P E E K A N A T O M I C A L C E R V I C A L C A G E
Contents
1. Esterilizaci n Recomendamos la esterilizaci n en autoclave para los implantes y los instrumentos precalentamiento 25 a 110 C 1 bar vac o 5 0 8 bares bajo presi n atmosf rica calefacci n 5 a 120 C 1 bar vac o 5 0 8 bares esterilizaci n 18 a 134 C 2 bares secado 20 retorno a temperatura ambiente RECLAMACIONES Cualquier reclamaci n acompa ada de la referencia y del n mero de lote del producto correspondiente debe dirigirse a la sociedad Scient x Fecha de la actualizaci n del folleto 24 07 2006 CE 0459 2001 Additional information Renseignements Weitere Angaben Informac es complementares SCIEN TI X B timent Calypso Parc Ariane 3 5 rue Alfred Kastler 78284 Guyancourt FRANCE TL 33 0 1 39 30 69 30 FX 33 0 1 30 43 82 77 www scientx com info scientx com Samarys Poster presented at the CSRS Meeting Barcelona June 2003 0 EVALUATION OF AN INTERVERTEBRAL CERVICAL CAGE FILLED WITH INJECTABLE BONE SUBSTITUTE Authors H Pascal Moussellard E Aguado Y Catonn J L Rouvillain G Daculsi Service d Orthop dic H pital Pierre Zobda Quitman Cit La Meynard 97200 Fort de France Martinique Laboratoire de Chirurgie Ecole nationale V t rinaire de Nantes Roste de Gachet BP 49706 44307 Names cedex 03 France Service d Orthop die H pital Piti Salpetri amp re 47 Ed de l h pital 75013 Pari2. PEEK ANATOMICAL CERVICAL CAGE X SCIENT X YOUR EXPERTISE Samerus ee RES ANO ERNNENESIRTES Ihe gu 6 2 28 A Features and Benefits of PEEK OPTIMA PEEK OPTIMA by Invibio is a pure PEEK material designed to meet spine hip and dental implants requirements Young s Modulus GPa 200 150 Stainless 5 Safety PEEK OPTIMA 100 Elasticity prevents sinking Titanium Cortical TA6V less risk of penetration 50 Cancellous Rupture modulus is lower than metal bone less risk of bone damage 0 Withstands repeated autoclave sterilizations Medical imaging X ray CT MRI Radiolucent material to allow accurate fusion follow up Embedded gold markers to facilitate implant placement verification Enhanced bone fusion No stress shielding Biocompatibility Optimum load repartition No carbon fibres no risk of inflammatory reaction Bone growth enhancement thanks to micromovements CE marked and cleared by FDA for long term implantation in the human body Interbody arthodesis is a secure and efficient technique to treat cervical spine pathologies The Samarys anterior cage answers all the requirements di of this technique lts unique design allows a maximum interbody fusion The Samarys cage anatomical design offers an optimum a a Stability stability and its wide range of sizes allows a perfect adaptation t
3. l emballage doit tre intact r ception Si le syst me de kit en d p t est utilis la composition compl te du kit doit tre attentivement v rifi e Le bon tat de tous les implants et instruments doit tre contr l avant toute utilisation Les conditions de stockage doivent permettre de maintenir l int grit des implants des ancillaires associ s et de leurs emballages respectifs Les produits endommag s ne doivent pas tre utilis s et doivent tre retourn s SCIENT X gt Attention Aucun produit base de silicone de formald hyde ou de latex ne doit tre implant avec un implant SCIENT X D CONTAMINATION NETTOYAGE STERILISATION Les produits livr s en sachets ne sont pas st riles gt Pour les implants livr s st riles Les implants sont st rilis s par rayonnement Gamma la dose de 25 40 kGy Le d lai de p remption est de 5 ans La date limite d utilisation des l ments st riles est indiqu e sur l emballage gt Pour les implants et instruments livr s non st riles Tous les implants et instruments livr s non st riles doivent tres d contamin s nettoy s et st rilis s avant et apr s utilisation Les implants et les instruments en sachet doivent tre sortis de leur emballage d origine pour les op rations suivantes M thode conseill e D contamination Plonger les implants et les instruments dans une solution bact ricide et fongicide de type chlorure did c
4. 00 211CC2A01 Cage holder with stopper 211CC2A03 Socket for Samarys cage 2150C02 Screwdriver for distraction pin 21TRVO3 Pliers 030929 On request AN ATOMIC AL SIMIVVS vicar cace B timent Calypso Parc Ariane 3 TL 33 0 1 39 30 69 30 5 rue Alfred Kastler FX 33 0 1 30 43 82 77 78284 Guyancourt FRANCE wwwscientx com info scientx com Please read carefully the instructions for use bulletin Devices may be subject to modification Patented 88BTN11CC2A A Version 2 0 July 2006
5. BENWIRKUNGEN e Infektion e postoperative Migration des Implantats Verletzung der an die Spondylodese angrenzenden Wirbeletagen Unvertraglichkeitsreaktion auf das Material gt Hinweis Zur Korrektur einer Nebenwirkung kann eine zus tzliche Operation erforderlich werden 2 Warnung Nicht jeder operative Eingriff ergibt immer ein zufriedenstellendes Ergebnis Das gilt vor allem auch bei Wirbels ulenoperationen wo das Ergebnis durch viele u ere Faktoren beeintr chtigt werden kann VORSICHTSMASSNAHMEN BEI DER OPERATION Der Chirurg muss mit dem anterioren Zervikal Cage Samarys der Applikationsmethode dem Instrumentarium und der Operationstechnik vertraut sein sie ist ahnlich wie beim Cage CBK Bei der Auswahl der Gr e des anterioren Zervikal Cages Samarys lasse man sich von dem klinischen Fall und der gew nschten Korrektur leiten Zum Offnen des Zwischenwirbelraums in den der K fig implantiert werden soll empfiehlt sich die Verwendung eines Distraktors vom Caspar Typ Vor der Implantation des anterioren Zervikal Cages Samarys werden die Abschlussplatten der Wirbelk rper sorgfaltig k rettiert und angefrischt ohne sie jedoch br chig zu machen damit der K fig nicht einsinkt Der anteriore Zervikal Cage Samarys muss mit autologem allogenem Knochen oder einem Knochenersatz angef llt werden um die Knochenfusion zu erm glichen Die richtige Positionierung des K figs im Verh ltnis zu den Wirbeln wird mit R ntg
6. Screwdriver for distraction pin 21TRVO3 3 Preparing the vertebral plates The endplate preparation is performed with a curette This step must be sufficiently thorough in order to extract all discal debris but not so pronounced as to collapse the cancellous bone which would lead to secondary graft collapse The intersomatic height may be restored in different ways autologous heterologous graft or interbody cages Plate positioning is performed after resecting the anterior osteophytes This step is necessary to obtain a close contact between the plate and the anterior vertebral body surface The choice of the plate and its correct positioning are essential steps of the osteosynthesis 4 Placing the trials implant A set of implant trials is used to determine the ideal implant size The width of the trials is 17 or 20 mm and their height is from 5 to 7 mm These different sizes allow to find the implant that will fit to the anatomies and the needs of the patient The trial is secured to the holder and is impacted into the intervertebral space Having no retaining edges the trial can easily be removed Trial implant 21CC2Axx xx 5 Graft harvesting and cage filling The cage can be filled with a bone substitute or an autologous graft In cases of autogeneous bone grafting the graft harvesting is performed by way of a 15 mm Bone collection device incision on the anterior iliac crest A specific SL trefine can
7. be adapted by impact on the iliac crest and allows to obtain a transcortical harvesting on different angles Generally one or two samples are enough to fill the cage The closing of the iliac bone flap is made after haemostesis with wax Socket for Samarys cage 2150C02 hu hy my 3 a PA A WE The cage is positioned on its socket during the filling phase The upper and lower faces of the cage are widely opened to offer optimum graft volume and contact area A graft pusher matching the cage shape is used to compact the graft Graft pusher 21COMO03 5 Installing the cage After filling the cage is secured to the holder tool The holder is then positioned onto the cage The end piece of the holder is inserted on the front side of the implant and ensures full locking The holder has small dimensions and locks in continuation of the cage The cage can be impacted or installed with slight distraction on the distractor The stop secured at the top end of the holder allows impacting the implant The holder is removed after implanting the cage Cage holder 21CC2Axx Note The cervical cage ensures immediate post operative stability of the spine but in some cases according to the physician s advice internal fixation with an anterior cervical osteosynthesis plate or external collar or brace can be added according to the surgeon s habits Closing the approach wound The approach
8. bis 40 kGy sterilisiert Die Verfallszeit betr gt f nf Jahre Das Verfallsdatum der sterilen Teile steht auf der Verpackung gt Bei nicht steril gelieferten Implantaten und Instrumenten Alle nicht steril gelieferten Implantate und Instrumente m ssen vor und nach Gebrauch dekontaminiert gereinigt und sterilisiert werden Die Implantate und Instrumente in Beuteln m ssen aus ihrer Originalverpackung genommen und folgenden Behandlungen unterzogen werden Empfohlene Methode Dekontamination Die Implantate und Instrumente in eine bakterizide und fungizide zu 0 5 verd nnte L sung vom Typ Didecyldimethylammonium Chlorid tauchen 5 ml auf 1 Liter lauwarmes Wasser Baddauer 20 Min Danach mit demineralisiertem Wasser absp len e Reinigen Die Implantate und Instrumente in einer Maschine Typ LANCER mit geeigneten Reinigungsmitteln waschen absp len und trocknen Es d rfen keine Mittel verwendet werden die das Material angreifen konnten Chlor Formalin usw Sterilisation Wir empfehlen die Autoklav Sterilisation f r Instrumente Vorheizen 25 bei 110 1 Bar 5 Vakuum 0 8 Bar unter atmosph rischem Druck Heizen 5 bei 120 1 Bar 5 Vakuum 0 8 bar Sterilisation 18 bei 134 C 2 bar Trocknen 20 R ckgang auf Raumtemperatur REKLAMATIONEN Alle Reklamationen m ssen zusammen mit der Referenz und der Chargennummer des beanstandeten Produktes an die Firma Scient x geschickt werden Let
9. de permettre une d compression radiculaire par distraction intersomatique et une conception favorisant l ost ogen se Les indications comprennent stabilisation apr s cure de hernie discale cervicale ou d ost ophytose compressive sur les racines nerveuses et ou sur la moelle instabilit intervert brale d g n rative CONTRE INDICATIONS Les contre indications de la cage cervicale ant rieure Samarys comprennent infection ou inflammation locale ost oporose vert brale affection vert brale maligne allergie ou intol rance au PEEK ge et tat physique du patient incompatibles tout cas non compris dans les indications La cage cervicale ant rieure Samarys n est pas concue destin e ou vendue pour des utilisations autres que celles indiqu es EFFETS SECONDAIRES POSSIBLES infection migration post op ratoire de l implant atteintes des tages vert braux adjacents l arthrod se intol rance au mat riel gt Note Une intervention chirurgicale suppl mentaire peut tre n cessaire pour corriger un effet secondaire gt Avertissements Un r sultat enti rement satisfaisant n est pas syst matiquement obtenu chaque op ration chirurgicale Cela est particuli rement vrai en chirurgie du rachis o de nombreux l ments ext rieurs peuvent compromettre les r sultats PRECAUTIONS OP RATOIRES Le chirurgien doit tre parfaitement familiaris avec la cage cerv
10. ebrales para avivarlos pero sin tornarlos fr giles en evitaci n del riesgo de hundimiento de la caja La caja cervical anterior Samarys debe rellenarse con hueso aut logo alog nico o con un sustitutivo seo para lograr la fusi n sea El control radiol gico permite confirmar que la caja est en posici n correcta respecto a las v rtebras Tras el implante el n mero de lote y la referencia de la caja cervical anterior Samarys implantada deben anotarse sistem ticamente en el informe quir rgico del paciente Los implantes son para un solo uso Una vez extra do un implante nunca debe volver a implantarse gt Atenci n No debe implantarse ning n producto a base de silicona formal debido o l tex con un implante SCIENT X EMBALAJE Los implantes suministrados est riles est n acondicionados en embalajes est riles individuales Los implantes suministrados no est riles y sus instrumentos son suministrados en uno o varios contenedor uno varios kit excepto en el caso de renovaci n de kit s en dep sito Cada kit debe estar cerrado y sellado el embalaje debe estar intacto a la recepci n Si se utiliza el sistema de kit en dep sito la composici n completa del kit debe ser atentamente verificada El buen estado de todos los implantes e instrumentos debe ser controlado antes de cualquier uso Las condiciones de almacenamiento deben permitir mantener la integridad de los implantes del material auxiliar asociado
11. ecci n vertebral maligna alergia o intolerancia a la polieterotercetona PEEK edad y estado f sico del paciente incompatibles cualquier caso no incluido en las indicaciones La caja cervical anterior Samarys no est pensada ni se vende para otros usos que los indicados EFECTOS SECUNDARIOS POSIBLES infecci n desplazamiento postoperatorio del implante afectaci n de los estratos vertebrales adyacentes a la artrodesis intolerancia al material 2 Nota Puede ser necesaria una intervenci n quir rgica complementaria para corregir un efecto secundario gt Advertencia No siempre se obtienen resultados completamente satisfactorios en todas las intervenciones quir rgicas Ello es especialmente aplicable a la cirug a de la columna vertebral en que son numerosos los elementos externos que pueden comprometer los resultados PRECAUCIONES OPERATORIA El cirujano debe estar perfectamente familiarizado con la caja cervical anterior Samarys el m todo de implantaci n los instrumentos y la t cnica operatoria similar a la de la caja CBK El tama o de la caja cervical anterior Samarys se debe escoger en funci n del caso cl nico y de la correcci n que se desee hacer Se recomienda utilizar un distractor separador tipo Caspar para abrir el espacio intervertebral destinado a recibir la caja Antes del implante de la caja cervical anterior Samarys debe hacerse un cuidadoso curetaje de los platillos vert
12. en kontrolliert Nach der Implantation m ssen immer die Los und Bestellnummern der implantierten anterioren Zervikal Cages Samarys in die Operationsunterlagen des Patienten eingetragen werden Die Implantate sind nur zum einmaligen Gebrauch Explantierte Implantate d rfen auf keinen Fall wiederverwendet werden gt Achtung Bei SCIENT X Implantaten d rfen keine silikon oder formaldehyd oder latexhaltigen Produkte implantiert werden VERPACKUNG Die steril gelieferten Implantate sind einzeln steril verpackt Die nicht steril gelieferten Implantate und ihre Instrumente werden in einem oder mehreren Beh ltern so genannten Sets geliefert au er bei der Auff llung von vor Ort gelagerten Sets Jedes Set muss verschlossen und versiegelt sein die Verpackung muss bei Erhalt intakt sein Wird des gelagerte Setsystem verwendet muss die vollst ndige Zusammensetzung des Sets sorgi ltig berpr ft werden Der einwandfreie Zustand s mtlicher Implantate und Instrumente muss vor jeder Anwendung kontrolliert werden Die Lagerbedingungen m ssen zur Erhaltung der Integritat der Implantate des Zubeh rs und ihrer jeweiligen Verpackungen geeignet sein Verwenden Sie besch digte Produkte nicht und senden Sie sie an SCIENT X zur ck DEKONTAMINATION REINIGUNG UND STERILISATION Die in Beuteln gelieferten Produkte sind nicht steril gt Bei steril gelieferten Implantaten Die Implantate werden mit Gammastrahlen bei einer Dosis von 25
13. eral phase were explanted Results SCANNING ELECTROMIC MICROSCOPY SEM _JEDL ISM 6300 Try Japon Qualitative analysis Quantitative analysis Polarized Light 4 1 d 5 EMPTY CAGE Le xm J us TE 7 Pres hem Ls Paradas Ii Sa CAGE BONE s re Ix CAGE Discussion Mary human clinical studies showed that fusion can be achieved in the cervical spine without amy graft material We tested thus the implantation of an empty cage The systematic absence of fusion emphasizes the need for a graft material into the cage Average fusion rate of cervical spine arthrodesis using autologous bone graft with animal models is 46 8 range 38 62 1 2 5 6 17 8 10 11 12 In our study we observed a fusion rate of 80 for cages associated to auto logous bone This very high rate of fusion validates the use of the cage with autologous bone for cervical arthrodesis The results of the quantitative SEM analysis for the bone substitute IBS are very closed to those obtained with autologous graft The association of BCP granules Lo the HPMC vehicle phase nearly gives IBS the struc ture of a totally interconnected macroporous ceramic 3 3 This kind of structure helps the dynamic of the ceramic resorption bone substitution process and allows an early newly formed bone appearance 4 The use of this biomaterial s bone substitute is very promising Conclusion This histological study valida
14. g the following conditions pre heating 25 min at 110 C 1 bar vacuum 5 min 0 8 bar under atmospheric pressure heating 5 min at 120 C 1 bar vacuum 5 min 0 8 bar sterilization 18 min at 134 C 2 bar drying 20 min return to room temperature COMPLAINTS Any complaints together with the reference and lot number of the incriminated product should be sent to Scient x Date of revision of this package insert 2006 07 24 0459 2001 Notice d instructions La cage cervicale ant rieure Samarys est un implant destin aux traitements chirurgicaux du rachis cervical DESCRIPTION GENERALE La cage cervicale ant rieure Samarys a t con ue pour permettre la stabilisation et l arthrod se inter somatique cervical La cage cervicale ant rieure Samarys pr sente une forme convexe sur sa face sup rieure et des ouvertures sur les faces sup rieures et ant rieures Plusieurs hauteurs et largeurs sont propos es pour s adapter aux diff rentes morphologies d espaces inter vertebraux La cage cervicale ant rieure Samarys est fabriqu e partir de PEEK La cage cervicale ant rieure Samarys ne doit pas tre utilis e avec des composants provenant d autres fabricants INDICATIONS La cage cervicale ant rieure Samarys est un implant chirurgical pour l arthrod se cervicale par voie ant rieure con ue pour optimiser la fusion osseuse C est une cage intersomatique dont les principaux objectifs sont
15. gen des Zwischenwirbelraums passenden H hen und Breiten Der anteriore Zervikal Cage Samarys ist aus Polymer PEEK Der anteriore Zervikal Cage Samarys darf nicht zusammen mit Komponenten von anderen Herstellern verwendet werden ANWENDUNGSGEBIETE Der anteriore Zervikal Cage Samarys ist ein chirurgisches Implantat zur Spondylodese im Bereich der HWS durch anteriore Fixierung und seine Konzeption optimiert die Knochenfusion Die vornehmliche Zweckbestimmung dieses interkorporellen Kafigs ist die Wurzeldekompression durch intervertebrale Aufdehnung und seine Konzeption beg nstigt die Osteogenese Zu den Indikationen z hlen e Stabiliserung nach operativer Behandlung eines zervikalen Bandscheibenprolapsus oder einer Osteophytose mit Nervenwurzel und oder R ckenmarkskompression degenerative intervertebrale Instabiltitat KONTRAINDIKATIONEN Zu den Kontraindikationen des anteriore Zervikal Cages Samarys z hlen e Infektion oder rtliche Entz ndung vertebrale Osteoporose b sartige Wirbelerkrankung Allergie gegen oder Unvertraglichkeit mit Polyetheretherketon PEEK Patient in einem nicht operationsf higen Alter oder Gesundheitszustand alle nicht unter die Anwendungsgebiete fallenden Befunde Der anteriore Zervikal Cage Samarys ist ausschlie lich f r die erw hnten Verwendungszwecke konzipiert Er eignet sich f r keinen anderen Verwendungszweck und wird auch nicht dazu zum Verkauf angeboten M GLICHE NE
16. iated to autologous bone graft or injectable bone substitute Material amp Methods Implant description Animal model Fusion assessment methods amp Samarys cervical cage a The goat has been chosen because of its validation as a model for The instrumented levels were fixed with methyl Scient x Guyancourt France the cervical spine metacrylate and prepared for undecalcified sectioning made of PEEK Poly Ether Ether Keton E A Fourteen animals underwent discectomy 3 44 cage insertion radiolucent x AS osteosynthesis Histological examination polarized light microscopy lordotic Moval s staining s dimensions 11310 w17 x h5 6 mm ue The 14 animals were divided into 3 groups Scanning Electronic microscopy SEM Injectable Bone Substitute IBS MBCP gel cae moe Nes We considered interbody fusion complete only if there was bone Biomatlante Vigneux de Bretagne France CAGE SPON BONE TIN e considered inter usion complete only if there was bon The MBCP gel is made of 2 phases n 6 bridging the disc space continuously rom endplate to endplate a mineral phase granules of biphasic calcium phosphate ceramic CAGE BONE SUBSTITUTE IBS n 5 160 hydroxvapatite 40 B tricalcium phosphate polymeric phase cellulose derivative polymer HPMC Goals were killed at 6 months postoperative and the 3 04 levels hydroxy propsi methyl celiulose vehicle for the calcium phosphate min
17. icale ant rieure Samarys la m thode d application les instruments et la technique op ratoire similaire celle de la cage CBK La taille de la cage cervicale ant rieure Samarys doit tre choisie en fonction du cas clinique et de la correction d sir e Il est recommand d utiliser un distracteur de type Caspar pour ouvrir l espace intervert bral destin recevoir la cage Avant implantation de la cage cervicale ant rieure Samarys les plateaux vert braux doivent tre curet s soigneusement et aviv s sans tre fragilis s pour viter les risques d enfoncement de la cage La cage cervicale ant rieure Samarys doit tre remplie d os autologue allog nique ou d un substitut osseux pour obtenir la fusion osseuse Un contr le radiographique permet de constater le bon positionnement de la cage par rapport aux vert bres Apr s implantation le num ro de lot et la r f rence de la cage cervicale ant rieure Samarys implant e doivent syst matiquement tre enregistr s dans le dossier chirurgical du patient Les implants sont usage unique Un implant d simplant ne doit jamais tre r implant EMBALLAGE Les implants livr s st riles sont conditionn es dans des emballages st riles individuels Les implants livr s non st riles et leurs instruments sont livr s dans un o plusieurs conteneur un des kit sauf dans le cas de r assortiment de kit s en d p t Chaque kit doit tre ferm et scell
18. o each patient s anatomy The particular shape and the pure PEEK composition of this implant ensure an excellent bone fusion Increased stability and fusion Original design for an optimum primary stability to restore the interbody space and preserve cervical lordosis a gt Large graft surface to enhance bone fusion Anatomical shape Reinforced security Designed to maximise contact with the 3 Inferior and superior teeth on surface intervertebral endplates to avoid risks of migration i 3 5RAA A 1 Surgical protocol Patient positioning The procedure is performed under general anesthesia with endotracheal intubation The patient is positioned in supine position on a standard table The head is placed in a neutral position or rotated in the opposite direction to the approach Rotation should be approximately 30 to limit stress on the sterno cleido mastoid muscle The shoulders are lowered and fixed with self adhesive strips in order to release the inferior cervical spine The skin incision targets the level of the lesion to be treated It is marked on the skin after locating the lesion with an image intensifier It may be horizontal along a skin fold extended to the opposite side of the median line in the case of bilateral approach or beyond according to the number of levels to be treated The platysma muscle is sectioned on the same plane as the skin then two upper and lower detachment
19. s France Equipe INSERM Mat riaux d int r t biologique EMI 9903 Facult de Chirurgie Dentaire place Alexis Ricordeau BP 84215 44042 Nantes cedex France Introduction Anterior cervical discectomy and arthrodesis with use of autogenous iliac crest bone graft Robinson and Cloward procedures is the gold standard procedure to treat degenerative changes of the cervical spine resulting in neck pain and or cervical myelopathy and radiculopathy The main problem of this procedure remains the morbidity associated to the iliac graft harvest The ideal system should respond to the following specifications a good primary stability a disc height conservation biocompatible material able to provide bony fusion with respect to both conditions fusion rate fusion obtained with autologous bone graft morbidity rate lt morbidity rate of the gold standard procedure We intend to evaluate an arthrodesis system combining an impacted intervertebral PEEK cage and an injectable bone substitute Thanks to its design and its mechanical strength the cage is a self stable implant primary stability and restores the local lordosis as well as the discal height The use of a bone substitute avoids the iliac bone harvest and then the morbidity associated Lo this procedure The parameter we will focus on is therefore the fusion rate Objective Qur objective is to evaluate the fusion rate of the arthrodesis obtained with a PEEK intervertebral cage assoc
20. s are created to avoid muscle tension The aponeurotic planes are sectioned with the finger up to the anterior surface of the spine The muscles along the neck are separated and rugined to thoroughly release the operating area and allow proper retraction using an autostatic distractor Under scopic control the proper level is located then the Caspar distractor pins are positioned in the middle of the vertebral bodies over and under lying the discal space to be treated and parallel to the endplates Then the anterior vertebral ligament is incised down to the lateral unco vertebral articular processes before distracting the space Discectomy is then carefully performed if necessary with the help of a microscope B Discectomy and preparation of the surgical site The discectomy starts with the rectangular excision of the anterior part of the annulus fibrosus using a scalpel The disc material is resected using curettes and rongeurs It may prove necessary to use a microscope for resecting the posterior disc material After full discectomy resecting the posterior osteophytes and the caudal part of the uncus allows foramen release For simple disc herniations it may prove sufficient to open the ligament toward the root and remove the herniation This essential surgical stage gives direct access to the anterior side of the medulla and nerve roots Cervical distractor 21DST02 Distraction pin 6 3 5 21FCD35 xx
21. ted the use of the impacted Scient x cage for cervical arthrodesis The fusion rate obtained when cage autologous bone are associated is the highest fusion rate reported in the literature The use of the IBS bone substitute is very promising Research is still in progress to improve the conditions of use of this material particularly to control the filling of the cage volume Recent advances in bone substitute and intervertebral cages give the opportunity to considerably reduce the morbidity rate at the donor site ViPS LSA Ne iS INSTRUMENTS Implants PEEK cervical cage Length 15 mm Height mm Width mm Reference 5 17 11CC2A17 5 6 11CC2A17 6 7 11CC2A17 7 8 11CC2A17 8 9 11CC2A17 9 10 11CC2A17 10 5 20 11CC2A20 5 6 11CC2A20 6 7 11CC2A20 7 8 11CC2A20 8 co 11CC2A20 9 10 11CC2A20 10 Available sterile 11CC2A_ Short PEEK cervical cage Length 13 mm x mm Width mm Reference 110C2AC17 5 6 11CC2AC17 6 Instruments Trial implant for Reference 11CC2A17 5 21CC2A17 5F 11CC2A17 6 21CC2A17 6F 11CC2A17 7 21CC2A17 7F 11CC2A20 5 21CC2A20 5F 11CC2A20 6 21CC2A20 6F 11CC2AC17 5 21CC2AC17 5F h1QCgACU L 6 21CC2ACI7 6F 6 21CC2AC17 6F Distraction pin 3 5 21FCD35 14 16 21FCD35 16 18 21FCD35 18 Bone collection device guide 20 1 3 Bone collection device 20 2 3 Graft pusher for bone collection device 20 3 3 Graft pusher 21COMO03 Cervical distractor 21DST02 Cage holder 2
22. teogenesis The indications include stabilisation after treatment of a herniated cervical intervertebral disc or osteophytosis compressing the nerve roots or spinal cord degenerative intervertebral instability CONTRAINDICATIONS The contra indications for the Samarys anterior cervical cage include local infection or inflammation vertebral osteoporosis malignant vertebral disease allergy or intolerance to PEEK incompatible patient age and physical condition all cases not included in the indications The Samarys anterior cervical cage has not been designed intended or sold for uses other than those indicated POSSIBLE ADVERSE EFFECTS infection post operative migration of the implant damage to the vertebrae adjacent to the arthrodesis intolerance to the material gt Note An additional surgical operation may be needed to correct any adverse event gt Warnings An entirely satisfactory result is not always obtained at each and every operation This is particularly true in spinal cord surgery where many external factors can compromise the results OPERATING PRECAUTIONS The surgeon must be thoroughly familiar with the Samarys anterior cervical cage the method of application the instruments and the operating technique similar to that of the CBK cage The size of the Samarys anterior cervical cage must be chosen in relation to the individual clinical case and the desired correc
23. tion It is recommended to use a Caspar type distractor to open the intervertebral space intended for implanting the cage Before implanting the Samarys anterior cervical cage a careful curetage of vertebral faces must be conducted to expose healthy tissue but without making them fragile to prevent the cage from slipping inwards The Samarys anterior cervical cage must be filled with autologous or allogenic bone or with a bone substitute to obtain bone fusion The correct positioning of the cage with respect to the vertebrae is confirmed by radiology After implantation the batch number and the reference of the implanted Samarys anterior cervical cage must always be recorded in the patient s surgical records This can be done using one of the labels attached to the sterile packaging The implants are single use removed implant must never be implanted again gt Warnings No silicone formaldehyde or latex based products should be implanted with a SCIENT X implant PACKAGING Implants delivered sterilized are conditioned in individual sterile packages Implants delivered non sterile and their instruments are delivered in one or more containers one or more kits except in the case of non assorted kits for stocks Each kit must be closed and sealed The packaging must be intact upon reception If the stocked kit system is used complete kit composition must carefully be checked The proper state of all implants and instrumen
24. ts must be checked prior to any use Storage conditions must enable implant accessories and packaging integrity to be maintained Damaged products must never be used and must be returned to SCIENT X products must not be used but must be returned to SCIENT X DECONTAMINATION CLEANING STERILISATION Products delivered sachets are not sterile gt For the implants delivered sterile The implants are sterilized by Gamma radiation at doses of 25 to 40 kGy The expiry date is 5 years The expiry date of sterile parts is indicated on the packaging gt For implants and instruments not sterile on delivery All implants and instruments delivered non sterile must be decontaminated cleaned and sterilised before and after use Implants and instruments in sachets must be removed from the original packaging for the following operations Recommended method Decontamination Plunge the implants and instruments into a bactericidal and fungicidal solution of the didecyldimethylammonium chloride type diluted to 0 5 5mL to 1 litre water Length of soaking 20 min Rinse with demineralized water e Cleaning Wash the implants and instruments in a LANCER type machine with suitable cleaning products rinse and dry Any product that might damage the equipment is forbidden such as bleach formol etc It is essential to sterilise the kit by steam using the following conditions Sterilization It is essential to sterilise the kit by steam usin
25. wound is closed after rinsing The haemostasis is checked and a suction drain is placed on the anterior face of the spine The platysma muscle must be carefully restored and the skin closed by intradermic stitches with resorbable thread Removing the implant If the instrumentation must be removed before fusion the cervical approach is used down to the instrumented area Bone bridges between the implant and the vertebral bodies must be sectioned The holder is placed on the cage to facilitate implant removal Samarys Instructions for use The Samarys anterior cervical cage is an implant intended for the surgical treatment of the cervical vertebrae GENERAL DESCRIPTION The Samarys anterior cervical cage has been designed for stabilisation and arthrodesis between the cervical vertebrae The Samarys anterior cervical cage is convex in shape on its upper face and on the openings on the upper and anterior faces It comes in several sizes to adapt to the variable morphology of the inter vertebral spaces The Samarys anterior cervical cage is made from PEEK The Samarys anterior cervical cage must not be used with components coming from other manufacturers INDICATIONS The Samarys anterior cervical cage is a surgical implant for cervical arthrodesis by anterior route designed to optimize bone fusion It is an intersomatic cage whose main function is radicular decompression by intersomatic distraction and a design favouring os
26. y de sus embalajes respectivos Los productos da ados ser utilizados y deben ser devuetos a SCIENT X DESCONTAMINACI N LIMPIEZA Y ESTERILIZACI N Los productos entregados en bolsas no son est riles gt Para los implantes que se entregan est riles Los implantes est n esterilizados por radiaci n Gamma a dosis de 25 a 40 kGy El plazo de caducidad es de 5 a os La fecha l mite de uso de los elementos est riles viene indicada en el embalaje gt Para los implantes e instrumentos que se entregan sin esterilizar Todos los implantes e instrumentos que se entregan sin esterilizar deben ser descontaminados limpiados y esterilizados antes y despu s de su USO La descontaminaci n disminuye la poblaci n de microorganismos y facilita la limpieza adem s la esterilizaci n solamente ser eficaz si el material est limpio M todo aconsejado e Descontaminaci n Sumergir los implantes y los instrumentos en una soluci n bactericida y fungicida de tipo cloruro didecilmetilamonio diluida al 0 5 5 ml por 1 litro de agua tibia Duraci n del remojo 20 min Enjuagar con agua desmineralizada Limpieza Lavar los implantes y los instrumentos en una m quina tipo LANCER con productos de limpieza adaptados enjuagar y secar Debe evitarse todo producto susceptible de alterar el material lej a formol Es obligado esterilizar el kit por el procedimiento de vapor de agua ajust ndose a los siguientes par metros
27. yldim thylammonium dilu e 0 5 5ml pour 1 litre d eau ti de Dur e du trempage 20 min Rincer l eau d min ralis e e Nettoyage Laver les implants et les instruments en machine de type LANCER avec des produits de nettoyage adapt s rincer s cher Tout produit susceptible d alt rer le mat riel est proscrire eau de javel formol ll est imp ratif de st riliser le kit par le proc d vapeur d eau en utilisant les param tres suivants St rilisation Nous recommandons le mode de st rilisation en autoclave pour les implants et les instruments pr chauffage 25 110 C 1 bar vide 5 0 8 bar sous pression atmosph rique chauffage 5 120 C 1 bar vide 5 0 8 bar st rilisation 18 134 C 2 bars s chage 20 retour l ambiante RECLAMATIONS Toute r clamation accompagn e de la r f rence et du num ro de lot du produit incrimin doit tre transmise la soci t Scient x Date de r vision de cette notice 24 07 2006 0459 2001 Gebrauchsanweisung Der anteriorer Zervikal Cage Samarys ist ein Implantat zur chirurgischen Behandlung der Halswirbels ule ALLGEMEINE BESCHREIBUNG Der anteriore Zervikal Cage Samarys ist speziell zur Stabilisierung und Spondylodese der Halswirbel konzipiert Der anteriore Zervikal Cage Samarys hat eine konvexe Oberseite und grofe Offnungen oben und seitlich Es gibt ihn in mehreren zu den verschiedenen Ausgestaltun
28. zte berarbeitung dieser Gebrauchsanweisung 24 07 2006 0459 2001 Manual de instrucciones La caja cervical anterior Samarys es un implante para tratamiento quir rgico de la columna cervical DESCRIPCI N GENERAL La caja cervical anterior Samarys ha sido concebida para la estabilizaci n y la artrodesis intersom tica cervical La caja cervical anterior Samarys tiene forma convexa en la cara superior y aberturas en las caras superiores y anteriores Se fabrica en varias alturas y anchuras para adaptarla a las diversas morfolog as de los espacios intervertebrales La caja cervical anterior Samarys se fabrica en material PEEK La caja cervical anterior Samarys no debe utilizarse con elementos procedentes de otros fabricantes INDICACIONES La caja cervical anterior Samarys es un implante quir rgico para artrodesis cervical por v a anterior concebido para lograr una fusi n sea ptima Es una caja intersom tica cuyos principales objetivos son lograr la descompresi n radicular por separaci n intersom tica y favorecer la osteog nesis gracias a su dise o Las indicaciones son estabilizaci n tras cura de hernia discal cervical o de osteofitosis compresiva sobre las ra ces nerviosas y o sobre la m dula inestabilidad intervertebral degenerativa CONTRAINDICACIONES Las contraindicaciones de la caja cervical anterior Samarys son infecci n o inflamaci n local osteoporosis vertebral af
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