PCB EVOLUTIONTM
Contents
1. PCB EVOLUTION 2 in 1 hybrid cervical plate cage Corporate Headquarters ALPHATEC SPINE INC 5818 El Camino Real Carlsbad CA 92008 USA TL 1 460 431 9286 www alphatecspine com International Headquarters SCIENT X ALPHATEC SPINE 22 avenue Jean Bart 78960 VOISINS LE BRETONNEUX FRANCE TL 33 0 1 39 30 69 30 FX 33 0 1 30 43 82 77 www scientx com www alphatecspine com This product is not available for sale in the United States of America Non contractual pictures Please read carefully the instructions for use bulletin Devices may be subject to modification Patented Scient x CY Alphatec Spine Solutions for the Aging Spine SURGICAL TECHNIQUE GUIDE PCB Evolution and the Scient x Alphatec Spine logo are registered trademarks of Alphatec Spine 2010 Alphatec Spine Inc All rights reserved Scient x CY Alphatee Spine Solutions for the Aging Spine DOMKT503 en revision 1 0 DMQ 11 057 Approval date June 201 1 FEATURES amp BENEFITS 2 in 1 hyond Cervical plate cage 2 in 1 system e Integrated plate cage for a secured system e Easy and fast insertion e Optimal fixation of the spinal segment Hybrid implant e Titanium plate for a better mechanical resistance Titanium TA6V ELI gives excellent biomechanical properties and allows scanner and MRI investigations An evolution of the 2 in 1 titanium cervical plate cage PCB Scient x has designed a 2 in 1 system2. collapse 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 PCB Evolution trials A set of PCB Evolution trials are used to determine the ideal implant size It exists a trial by implant size the color code facilitates the identification of the implant corresponding to the trial The trial is secured to the holder and is impacted into the intervertebral space Cervical distractor Screwdriver Distraction pin 3 5mm Trials 21DST02 for distraction pin 21FCD35 xx 21PCBH__F 21TRVO3 SURGICAL TECHNIQUE AI B 5 Holding the PCB Evolution El The plate cage holder is inserted in the slots on each side of the cylindrical opening on the anterior side of the plate The internal pin of the holder is screwed into the threaded hole of the plate The small dimensions of the tool allow to preserve visibility of the operative area while ensuring reliable fixation I Graft insertion Before the insertion of the plate cage bone graft material has to be compacted autologous bone substitute or inserted oreshaped block of bone substitute in the Implant to ensure good density and optimal contact with the vertebral endplates Option a Autologous allogenic bone graft or bo
3. combining a titanium plate and a PEEK cage The PCB Evolution allows disc height restoration by an anterior fixation and the radiotransparent cage permits a perfect visualization of cervical interbody fusion Its unique stabilization plate prevents any possibility of posterior impaction or anterior ejection of the cage Operative time saving Rapid and simplified identification of the available sizes thanks to color code e Radiotransparent PEEK cage to allow accurate fusion follow up PEEK is a biocompatible polymer which presents a modulus of elasticity close to that of cortical bone therefore enhancing bone growth The PCB Evolution plate cage is mainly used for the surgical treatment of e cervical hard and soft disc herniations e cervical degenerative pathologies on one or several levels e instabilities resulting in degenerative disc disease e corrections of spine statics disorders This implant can be implanted from C2 to C7 Anatomical shape e Pre lordosed low profile plate to minimize stress upon fixation screws e Cage height to ensure the restoration of the intervertebral space Multi level implantation Asymmetrical shape to combine several plate cages in multi segment arthrodesis The PCB Evolution implant is available in different sizes allowing a perfect adaptation to the patient s anatomical curvature Its anatomically designed shape fits perfectly the intervertebral space while minimizing stress
4. 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 e D contamination Plonger les implants et les instruments dans une solution bact ricide et fongicide de type chlorure did cyldim thylammonium dilu e a 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 e St rilisation Nous recommandons le mode de st rilisation en autoclave pour les implants et les instruments pr chauffage 25 a 110 C 1 bar vide 5 0 8 bar sous pression atmosph rique chauffage 5 a 120 C 1 bar vide 5 0 8 bar St rilisation 18 a 134 C 2 bars s chage 20 retour a l ambiante E R CLAMATIONS 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 E INFORMATIONS COMPL MENTAIRES Pour toute information compl mentaire contactez Scient x Notice titre informatif Sujet modification Notice compl te disponible aupr s de votre service client Additional informations Renseignements Ulteriori informazioni Informaci n co
5. 40 10 16 11VC40 16 Length Ref Length Ref Cervical revision screw Diameter 4 5 mm Length Ref Length Ref mm mm 12 11VC45 12R 16 11VC45 16R 14 11VCA5 14R 18 11VC45 18R Available sterile PCBH65 CE oass plate center length distance cage height Screwdriver for distraction pin 21TRVO3 Bender 2 1GINOS Plate cage holder 21PRE14 Socket 2150C07 Graft compactor 21COM06 Snap on handle 21MAEO1M Square end 21PCO2E Distraction pin 3 5 mm 21FCD35 xx Trials for 11PCBHxx 21POCBHXXF Screw tap 21TAROSE Screwdriver 21TRVOTE Length mm 14 21FCD35 14 1 6 21 FCD35 1 6 On request Delivery time to be confirmed with order
6. Evolution is bent in the sagittal plan to follow the cervical lordosis and is drilled to allow fixation to vertebrae Both superior and inferior plates are curved in the frontal plan they are diagonally opposite allowing the implantation of two PCB Evolution on two adjacent levels Several sizes are available to allow a better choice for each individual case The plate is made of surgical implant applications titanium alloy described by ISO standard 5832 3 or ASTM F 136 The cage is made of radiolucent PEEK Optima The PCB Evolution cervical system must not be used with components from other manufacturers nor with other screws than cervical ones of SCIENT X E INDICATIONS The PCB Evolution are surgical implants for cervical arthrodesis through anterior approach They are intersomatic spacing cages associated with fixation plates which main objectives are a radicular decompression by intersomatic distraction and a design facilitating interbody fusion Indications for use include e cervical discal hernia e cervical degenerative lesions of one or several vertebrae e instability resulting from degenerative disc diseases e corrections of spinal static disorders E CONTRAINDICATIONS Contraindications of PCB Evolution include e local infection or inflammation e spinal osteoporosis e vertebral tumorous affection e titanium and its alloys allergy or intolerance e incompatible patient s age or physical state e any case
7. Rinse with demineralized water 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 Sterilization We highly recommend to sterilise the kit by steam using the following conditions pre heating for 25 at 110 C 1 bar vacuum 5 0 8 bar under atmospheric pressure heating 5 at 120 C 1 bar vacuum 5 0 8 bar sterilization 18 at 134 C 2 bars drying 20 return to room temperature E COMPLAINTS Any complaints together with the reference and lot number of the incriminated product should be sent to Scient x E ADDITIONAL INFORMATION For further information contact SCIENT X Only for information Subject to modification without notification For updated IFU please contact your local customer service Additional informations Renseignements Ulteriori informazioni Informaci n complementaria scient x 22 avenue Jean Bart 78960 VOISINS LE BRETONNEUX FRANCE TL 33 0 1 39 30 69 30 FX 33 0 1 30 43 82 77 qualite scientx com Do not use if package is damaged Ne pas utiliser si l emballage est endommag Non utilizare se la confezionz appare dannegiata No utilizar si el emalaje esta da ado Non sterile Sterile Non st rile St rile Non sterile STERILE R Sterile No est ril Est ril Date of manufactur Manufacturer Date d
8. ant du proc d de d contamination Le fabricant n accepte aucune responsabilit concernant les produits r utilis s Attention aucun produit base de silicone de formald hyde ou de latex ne doit tre implant avec un implant Scient x E MANIPULATION STOCKAGE La manipulation du mat riel PCB Evolution doit tre effectu e aussi peu souvent que possible et avec pr cautions Le stockage des implants PCB Evolution dans leur conditionnement d origine doit tre r alis avec soin dans un environnement propre et sec Ne pas exposer les implants PCB Evolution des rayonnements ou des temp ratures extr mes Le non respect de ces prescriptions peut provoquer une baisse des caract ristiques m caniques pouvant conduire dans certains cas leur rupture Les instruments chirurgicaux sp cifiques l instrumentation PCB Evolution devront tre v rifi s sur le plan fonctionnel avant toute intervention i DECONTAMINATION NETTOYAGE ET STERILISATION Les produits livr s en sachets ne sont pas st riles 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 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
9. artir d alliage de titane implantable selon les normes ISO 5832 3 ou ASTM F 136 et la cage partir de PEEK afin de profiter de la radiotransparence de ce mat riau La plaque cage cervicale PCB Evolution ne doit pas tre utilis e avec des composants provenant d autres fabricants ni des vis autres que les vis cervicales SCIENT X E INDICATIONS La plaque cage cervicale PCB Evolution est un implant Chirurgical pour l arthrod se cervicale par voie ant rieure La partie cage est une cage intersomatique dont les principaux objectifs sont une d compression radiculaire par distraction intersomatique et une conception favorisant l ost ogen se Les indications comprennent e hernie discale cervicale e atteinte d g n rative cervicale a un ou plusieurs tages e instabilit s r sultant de discopathies d g n ratives e corrections de troubles de la statique rachidienne E CONTRE INDICATIONS Les contre indications de la plaque cage cervicale PCB Evolution comprennent e infection ou inflammation locale e ost oporose vert brale e affection vert brale maligne e allergie ou intol rance au titane ou ses alliages e age et tat physique du patient incompatibles e tout cas non compris dans les indications La plaque cage cervicale PCB Evolution n est pas con ue destin e ou vendue pour des utilisations autres que celles indiqu es E EFFETS SECONDAIRES POSSIBLES e infection e d placement d une vis cer
10. d rugined to thoroughly release the operating area and allow proper retraction using an autostatic distractor El Under scopic control the proper level is located 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 B Then the anterior vertebral ligament is incised down to the lateral uncovertebral articular processes before distracting the space Discectomy is then carefully performed if necessary with the help of a microscope 2 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 microscope for resecting the posterior disc material After full discectomy resecting the posterior osteophytes and the caudal part of the uncus allows foramen release Depending on the case the common posterior vertebral ligament may or may not need to be resected This essential surgical stage gives direct access to the anterior side of the medulla and nerve roots 3 Preparing the vertebral endplates 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 not to collapse the cancellous bone which would lead to secondary graft
11. de or latex based products should be implanted with a SCIENT X implant E HANDLING STORAGE The PCB Evolution should be handled with care as seldom as possible PCB Evolution implants in their original packaging should be stored in a clean dry environment Do not expose PCB Evolution to radiation or extreme temperatures Non compliance with these instructions may lead to deterioration in the mechanical properties that can cause rupture on insertion The special surgical instruments supplied with the PCB Evolution instrumentation must be checked to ensure that they are functional before any surgery E DECONTAMINATION CLEANING AND STERILIZATION Products delivered in sachets are not sterile For implants delivered sterile the implants are sterilized by Gamma radiation at doses of 25 to 40 kGy Sterilisation is valid 5 years from the date of manufacturing The expiry date of sterile parts is indicated on the packaging For implants and instruments delivered non sterile all implants and instruments delivered non sterile must be decontaminated cleaned and sterilized before and after use Implants and instruments in sachets must be removed from the original packaging for the following operations Recommended method e 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
12. e fabrication Fabricant Data di produzione Produttore Fecha de fabricaci n Fabricante Do not reuse Use only A usage unique Utiliser jusqu au Mono uso Utilizare entro De un solo uso Utilizar hasta el Read IFU Lire le mode d emploi Leggere le istruzioni Leer el modo de emplo Only for information Subject to modification without notification For updated IFU please contact your local customer service CE Date of revision 06 2010 Notice d instructions E OBJECTIF La plaque cage cervicale PCB Evolution est un implant destin aux traitements chirurgicaux du rachis cervical E DESCRIPTION GENERALE La plaque cage cervicale PCB Evolution combine une cage intersomatique et une plaque de fixation par vis cervicales La plaque et la cage sont assembl es de mani re rigide non articul e et sont non d montables La partie cage poss de une forme convexe sur ses faces sup rieure et inf rieure elle est largement ouverte sur ses parois inf rieure et sup rieure La partie plaque est compos e de deux pattes perc es pour la fixation par vis et excentr es dans le plan frontal en diagonale oppos e pour permettre la mise en place de deux plaque cages cervicales PCB Evolution sur deux tages adjacents La patte sup rieure est inclin e dans le plan sagittal pour pouser la lordose cervicale Plusieurs tailles sont propos es pour s adapter aux diff rentes morphologies La plaque est fabriqu e p
13. fitting the shape of the intervertebral chamber The selected plate cage will be placed on the centre line of the cervical spine The holder can be left in place until the Screws are secured Plate cage holder Graft compactor Socket Bender D1PRE14 21COM06 21S0C07 21CINO3 On request Delivery time to be confirmed with order Inserting the square end 9 Fixing the PCB Evolution The square end is used to prepare screw insertion into The selected screws are positioned using a screwdriver the cortical bone With its short cutting length it can only The conical hexagonal end provides security of the provide a predrilled hole The penetration length is limited screws during placement The screws are placed one by its special shape after the other always beginning with the inferior screw for final tightening to ensure the stiffness of the PCB Evolution vertebrae assembly The screw length is selected according to the clinical case and to the fixation mode used uncortical or bicortical Inserting the tao Closing the approach wound The screw tap is used to prepare screw insertion The tap The approach wound is closed atter rinsing The has a fixed stop limiting the penetration length to 14mm 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 Note The asymmetrical shape
14. fusion osseuse La stabilit secondaire de l implant est garantie par la mise en place de deux vis cervicales sp cifiquement d velopp es pour la PCB Evolution La plaque de la PCB Evolution pr sente deux orifices con us pour recevoir les vis et s adapter parfaitement la g om trie de leurs t tes Si la lordose de la plaque doit tre modifi e cette op ration doit tre faite uniquement sur l ailette sup rieure et ne doit pas d passer 5 de correction L angulation de la plaque ne doit pas tre modifi e de fa on r p t e Un contr le radiographique permet de constater le bon positionnement de la cage par rapport aux vert bres et des vis dans les corps vert braux Apr s implantation le num ro de lot et la r f rence de la plaque cage cervicale PCB Evolution implant e doivent syst matiquement tre enregistr s dans le dossier chirurgical du patient Ce produit est usage unique ne doit en aucun cas tre r utilis Bien que le dispositif puisse para tre en parfait tat il peut pr senter de petits d fauts ou des contraintes r siduelles r sultant d une utilisation ant rieure et pouvant mener une rupture en fatigue De plus veuillez noter que la d contamination des dispositifs r utilis s n est pas valid e et que les dispositifs n ont pas t con us en ce sens La r utilisation d un tel produit pourrait mener une contamination crois e et ou une d gradation du mat riel r sult
15. mplementaria scient x 22 avenue Jean Bart 78960 VOISINS LE BRETONNEUX FRANCE TL 33 0 1 39 30 69 30 FX 33 0 1 30 43 82 77 qualite scientx com Do not use if package is damaged Ne pas utiliser si l emballage est endommag Non utilizare se la confezionz appare dannegiata No utilizar si el emalaje est da ado Non sterile Sterile Non st rile St rile Non sterile STERILE R Sterile No est ril Est ril Date of manufactur Manufacturer Date de fabrication Fabricant Data di produzione Produttore Fecha de fabricaci n Fabricante Do not reuse Use only A usage unique Utiliser jusqu au Mono uso Utilizare entro De un solo uso Utilizar hasta el Read IFU Lire le mode d emploi Leggere le istruzioni Leer el modo de emplo A titre informatif Sujet modification Notice compl te disponible aupr s de votre service client CE Date of revision 06 2010 IMPLANTS amp INSTRUMENTS Hybrid plate cage Depth 16 mm Width 13 5 mm Plate thinness 0 8mm Color code Ref 16 17 18 silver 19 O Cage height Plate length Center distance mm mm mm D A ew 11PCBH75 Pre shaped bone substitute for 11PCBHxx OBX3PCBHXX Short hybrid plate cage Depth 14 mm Width 13 5 mm Cage height Plate length Center distance er g mm g mm OX 0 Meteo Ref Cervical distractor 21DST02 Cervical screw Diameter 4 mm mm mm 10 11VC
16. ne substitute The compaction is achieved with the graft compactor as the implant is maintained in the socket A Option b Pre shaped block of bone substitute Scient x offers a pre shaped block of bone substitute perfectly matching the PCB Evolution cage shape This block is made of biphasic ceramic hydroxyapatite tricalcium phosphate The block of bone substitute is inserted by the top in the cage while the implant is maintained into the socket B Being slightly higher than the cage the pre shaped bone substitute provides high compression of the graft and optimum contact with the adjacent vertebral endplates A notch on the posterior part of the bone substitute helps to locate its top part fa Bending of the plate optional A bender is provided in the set on request The bender is meant to help the surgeon contour the plate to best fit with the patient s specific anatomy Warning Scient x does not recommend multiple contouring or excessive bending The plate cage is positioned on the socket to secure the plate cage while bending The bender is then slid on the upper wing of the plate and a moderate bending Is applied Warning The bending of the plate should only be done on the upper wing of the implant 6 Positioning the PCB Evolution The PCB Evolution implant is inserted by exerting slight pressure on the holder The convex part of the cage facilitates cage positioning in the interbody space fully
17. not described in the indications The PCB Evolution are not designed intended or sold for uses other than those indicated E POSSIBLE ADVERSE EFFECTS e infection e instrumentation intolerance e screw displacement e damage of the intervertebral disc at above and or below the level of surgery Note Additional surgery may be necessary to correct some of these adverse reactions Warnings A successful result is not always achieved in every surgical case This fact is especially true in spinal surgery where many extenuating circumstances may compromise the results E OPERATING PRECAUTIONS The surgeon is to be thoroughly familiar with the PCB Evolution the method of application the instruments and the operating procedures recommended by SCIENT X The correct choice of the size of the PCB Evolution is very important this must be done in relation to the clinical case and the desired correction The use of a Caspar type distractor to open the intervertebral space which will receive the implant and the use of the trial implants for PCB Evolution to choose the best size of cervical system are recommended Before implantation of the PCB Evolution the vertebral endplates must be carefully prepared by removing the cartilaginous layer and roughening the subchondral bone It is important not to remove any of the bony endplate as this could lead to subsidence of the plate cage The cage must be filled with autologous bone allogeno
18. of the PCB Evolution allows its use in multi segment arthrodesis Post operative care The PCB Evolution ensures immediate cervical spine stability however in some cases according to the physician s advice an external collar or brace can be Snap on handle added for the patient s comfort 21MAEO1M Implant removal before fusion If the instrumentation needs to be removed the cervical approach is used down to the instrumented area The PCB Evolution holder inserted in the cylindrical threaded hole of the plate prevents any movement of the implant during removal The screws are removed using the gt hexagonal screwdriver When both screws are removed Square end Screw tap the use of a rugine between the cortical layer and the Screwdriver 21PCO2E 21TAROSE plate will facilitate extraction 21I RVO1E INSTRUCTIONS OF USE PCB EVOLUTION 2 in 1 hybrid cervical plate cage INSTRUCTIONS IMPLANTS amp INSTRUMENTS Instruction for use E OBJECTIVE The PCB Evolution implants are intended for surgical cervical treatments E GENERAL DESCRIPTION The PCB Evolution consists of an intersomatic cage integrated with a plate of fixation by cervical screws The plate and the cage are assembled in anon articulated rigid way and they can not be dismantled The cage part of the PCB Evolution has a convex shape on its superior and inferior faces and is widely opened on its inferior and superior parts The plate part of the PCB
19. upon fixation screws The PCB Evolution helps to restore the disc height and maintains correct spine static This one piece implant makes the placement easier and thereby reduces operative time Immediate stability Stabilization plate to prevent the pull out of the cage Optimized fusion Large graft surface to enhance bone fusion SURGICAL TECHNIQUE 1 Surgical protocol patient positioning El 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 sternocleido mastoid muscle The shoulders are lowered and fixed with self adhesive strips in order to release the inferior cervical spine M 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 detachments are created to avoid muscle tension The aponeurotic planes are sectioned with the finger up to the anterior surface of the spine fa The muscles along the neck are separated an
20. us bone or a bone substitute to facilitate the bone fusion Secondary anchorage is achieved by insertion of two cervical screws specifically developed for PCB Evolution The PCB Evolution plate presents two slots designed to receive the screws and perfectly fit to the geometry of the head screws If modification of the plate lorsosis is necessary make sure this gesture is only realized on the upper wing of the plate This correction must not exceed 5 The modification of the plate angulation should not be repeated An Xray check up makes it possible to confirm that the PCB Evolution has been correctly positioned relative to the vertebrae After implantation lot numbers and references of all the components of the implanted PCB Evolution must systematically be recorded in the surgical file of the patient This product is a single use device Under no circumstances should it be reused While the device may appear to be undamaged it may have small defects or internal stress patterns as a result of the prior implantation or removal that could lead to fatigue failure Additionnaly please note that the removed implant has not been designed or validated so as to allow for decontamination of microorganisms Reuse of this product could lead to cross infection and or material degradation as a result of the decontamination process The company accepts no responsability for products which have been reused Attention no silicone formaldehy
21. vicale e atteintes des tages vert braux adjacents l arthrod se e intol rance au mat riel Note Une intervention chirurgicale suppl mentaire peut tre n cessaire pour corriger un effet secondaire 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 E PR CAUTIONS OP RATOIRES Le chirurgien doit tre parfaitement familiaris avec la plaque cage cervicale PCB Evolution la m thode d application les instruments et la technique op ratoire La taille de la plaque cage cervicale PCB Evolution doit tre choisie en fonction du cas clinique et de la correction d sir e Le choix de cette taille est primordial puisqu il agit directement sur la stabilit primaire de l implant Il est recommand d utiliser un distracteur de type Caspar pour ouvrir l espace intervert bral destin recevoir la cage et d utiliser les fant mes de plaque cage afin de choisir la taille la plus adapt e Avant implantation de la plaque cage cervicale PCB Evolution 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 plaque cage cervicale PCB Evolution doit tre remplie d os autologue allog nique o d un substitut osseux pour obtenir la
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