Solitaire -C Cervical Spacer System - Zimmer Biomet...1 Introduction The Solitaire -C Cervical...

Surgical Technique

Solitaire™-C Cervical Spacer System

A Zero Profile Anterior Cervical Fusion Device

Large Graft Cavity and Multiple Footprint Options• Largeautograftcavityencouragesoptimal

healingenvironment• Comprehensiveofferingswiththree

spacerfootprints

Unique Spacer Band• Assistsdeviceplacementwithaccurate

radiographicvisualization• Color-codedwithscrewstoidentifyappropriate

screwdepth

Sophisticated Instruments Simplify Implantation• Uniqueinserterguideprovidesclearvisualization

ofholepreparationforscrewinsertion• Multiplescrewinserteroptions

B

Introduction ................................................ Page1

ProductOverview ........................................ Page2

FeaturesandBenefits .................................. Page3

Implants ...................................................... Page4

Instruments ................................................ Page5

SurgicalTechnique ..................................... Page9

Removal ...................................................... Page21

OrderingInformation .................................. Page22

Contents

IndicationsforUse ...................................... Page28

Contraindications ........................................ Page28

Warnings .................................................... Page28

Precautions ................................................. Page29

PotentialAdverseEffectsandComplications ...................................... Page30

Sterilization ................................................. Page30

FurtherInformation ..................................... Page31

1

Introduction

TheSolitaire™-CCervicalSpacerSystemisusedfor

stand-aloneanteriorcervicalinterbodyfusionprocedures

inskeletallymaturepatients.Itoffersseveraluniquefeatures

includingalargegraftcavity,threefootprintsizes(inboth

lordoticandparallel),auniquecolor-codedbandaroundthe

implantforeasierscrewidentification,andasophisticated

yetsimpleinstrumentationsystem.TheSolitaire™-CSystem

alsoofferstwolockingscrews(3.5mmand3.75mm)and

zeroprofileintheanteriorcervicalspine.

Thistechniqueguidedescribesasurgicaltechniqueusedby:

Todd J. Albert, M.D.

RichardRothmanProfessorandChair

DepartmentofOrthopaedicSurgery

ProfessorofNeurosurgery

Philadelphia,PA

J. Abbott Byrd, III, M.D.

StaffSurgeonandPresident

VirginiaBeach,VA

Andrew T. Dailey, M.D.

DepartmentofNeurosurgery

SaltLakeCity,UT

Yong H. Kim, M.D.

ClinicalAssistantProfessor

NewYork,NY

K. Daniel Riew, M.D.

Chief,CervicalSpineSurgery

StLouis,MO

Thesurgeonwhoperformsanyimplantprocedureis

responsiblefordeterminingtheappropriateproduct(s)and

utilizingtheappropriatetechnique(s)forsaidimplantationin

eachindividualpatient.

CAUTION:FederalLaw(USA)restrictsthisdevicetosale

byorontheorderofaphysician.

2

Solitaire™-C Spacers

TheSolitaire™-CSpacersarecomposedofaTitaniumalloy

faceplate,PEEK-OPTIMA®body,tantalummarkers,anda

Titaniumalloyband.TheTitaniumfaceplatesarecolor-coded

todenoteheight(seechartbelow).TheTitaniumbandsare

color-codedtodenotedepth.

Spacer Height Color

6mm Dark Green

7mm LightMagenta

8mm DarkBlue

9mm Gold

10mm Bronze

Spacer Depth Screw Length Color

12mm 12mm LightGreen

14mm 14mm Gold

15mm 15mm LightMagenta

Product Overview

Screws

Screwsareplacedatafixedtrajectoryof35°cephalad/

caudaland7°medial/lateral.Thescrewlengthisdefinedas

thedistance(inthelateralview)fromtheanteriorfaceofthe

spacertothetipofthescrew.Screwsarealsocolor-codedby

lengthwhichisdesignedtomatchspacerdepthandthecolor

oftheimplantband.Twoscrewsareintendedtobeplaced

intoeachspacersuchthatonescrewattachesthespacerto

thesuperiorvertebralbodyoftheaffectedlevelandtheother

screwattachesthespacertotheinferiorvertebralbodyofthe

affectedlevel.Screwslocktothetitaniumfaceplatebywayof

athreaded,cam-stylelockingmechanismthatistorquedwith

aminimumof14in.-lbs.tolockthescrewsinplace.Screws

aremanufacturedfromTitaniumalloy.

Screwsareofferedin3.5mmand3.75mmdiameters.The

3.5mmscrewsarefullycolored,whilethe3.75mmscrews

haveonlytheirheadscolored(whilethethreadsaresilver).

3

Features and Benefits

Large Graft Cavity and Multiple Footprint Options

• Largeautograftcavityencouragesoptimalhealingenvironment

• Comprehensiveofferingswiththreespacerfootprints

Unique Spacer Band

• Assistsdeviceplacementwithaccurateradiographicvisualization

• Color-codedwithscrewstoidentifyappropriatescrewdepth

Sophisticated Instruments Simplify Implantation

• Uniqueinserterguideprovidesclearvisualizationofholepreparationforscrewinsertion

• Multiplescrewinserteroptions

12mm 14mm 15mm

4

Implants

14mm

Spacers:

Footprint: 14mm(wide)x12mm(deep)

Heights:6.0mm–10mm(1.0mmincrements)

Shapes:ParallelandLordotic(7°)

Footprint:16mm(wide)x14mm(deep)



Footprint:18mm(wide)x15mm(deep)



Screws:

Length:12mm,14mm,15mm

Diameter:3.5mm

Length:12mm,14mm,15mm

Diameter:3.75mm

NOTE:Screwlengthisdefinedasthedistanceinthelateral

viewfromtheanteriorfaceofthespacertothetipofthe

screw.Thismeansscrewdepthwillbeequivalenttospacer

depthwhencorrespondingsizesareused.

5

Instruments

Trials

Rasps

Slim Inserter Guide

Open Inserter Guide

Inserter Handle

12mm Angled Awl

Fixed Angled Driver (45°)

Includes:

- AngledScrewDriverBit

- AngledDrillBit

- FixedAngledDriver

6

Tip with Malleable Shaft

Fixed Angle Bit Remover

Drill/Awl Sleeve

Spring-Loaded Drill/Awl Sleeve

Straight Drills

Straight Awls

Quick Connect Handle

Instruments (Continued)

7

Non-Retaining Flexible Driver

Threaded Screw Inserter

Torque Wrench Handle

Slide Hammer

Includes:

- SlideHammerAdapter

Driver Sleeve Family

Includes:

- DriverSleeve

- DriverforSleeves

- DriverSpringSleeve

Auto-Centering Driver

Non-Retaining Driver

Flexible Driver

8

Instruments (Continued)

Slotted Mallet

Graft Packing Caddy

Implant Remover

Includes:

- InnerShaft

- ImplantRemover

9

Surgical Technique

Step 1: Vertebral Body Distraction

Ifusingdistractionpins,placeonedistractionpininthe

vertebralbodysuperiortotheaffectedlevelandtheother

distractionpininthevertebralbodyinferiortotheaffected

level.ThePinDistractorisplacedoverthepinsandopened

asneededtodistractthevertebralbodies(beingcarefulnot

toover-distractthesegment).

Step 2: Discectomy and End-Plate Preparation

Usingrongeurs,pituitariesandcurettes,removethe

intervertebraldiscandosteophytesasneeded.Rasps

canalsobeusedtopreparetheendplatesandexpose

bleedingbone.

TheSolitaire™-Ctrialsandraspsaredouble-sidedfor

efficiency.Theseinstrumentscorrespondtotheimplant

footprintsandareavailablein5.0mm–10mmheightsin

1.0mmincrementssimilartotheimplants.(Pleasenote

thatthereisa5.0mmtrialandrasp,butthatheightisnot

availableinanimplant).

Also,theraspsaredesignedsothattheteethcutonthe

backstrokeastheinstrumentisbeingpulledawayfromthe

spinalcord.

NOTE:Aggressivepreparationoftheendplatemayremove

excessiveboneandweakentheendplate.

Usingastandardsurgicalapproach,exposethevertebral

bodiestobefused.Traditionalcervicalretractorsmaybe

used.Preparethefusionsitefollowingtheappropriate

techniqueforthespecificindication.

Figure1

Figure2

10

Surgical Technique (Continued)

Step 3: Implant Sizing

Usingthedouble-sidedraspsortrials,determinethe

appropriateimplantsizebysizingthediscspace.When

sizing,useincrementallylargersizesuntilatightfitis

achieved.Asecurefitisdesirabletomaintaindischeightand

stabilizethesegment,sothereshouldbenogapsbetween

thepreparedsiteandtrialorrasp.

Thetrialsandraspsarebothavailablewithorwithoutstops.

Thestopsallowforamaximumof2.0mmofcountersinkinto

thediscspace.

Oncethedesireddischeightisdetermined,selectthe

appropriateSolitaire™-Cimplant.Raspsandtrialshave

sleevesthatarecolor-codedtomatchtheheightofthe

correspondingspacer.

NOTE:Thetrial,raspandimplantheightsforeachparticular

sizeareallequal.Implantheightismeasuredtothesuperior/

inferiorsurfacesoftheTitaniumfaceplateandpeaksofthe

PEEK-OPTIMA®bodymacro-texture.Raspsaremeasuredto

thepeaksoftheteeth.

Step 4: Inserter Guide Assembly and Implant Attachment

TheSolitaire™-Csystemofferstwoinserterguideoptions,

slimandopen,thatthreadontotheinserterhandleand

facilitatescrewholepreparationandscrewinsertion

throughthesameinstrument.Bothguideoptionsallow

forvisualizationoftheimplant/endplateinterfaceand

screwinsertion.

Slim Inserter Guide

Thesliminserterguideprovidesvisualizationtothefrontof

thespaceronalateralx-ray.Thisinserterguidecanbeused

toplacescrewswithorwithoutholepreparation.Drill/Awl

andScrewsleevescanbeusedwiththisguide.

Open Inserter Guide

Theopeninserterguideprovidesmorevisualizationthanthe

sliminserterguide.Alldrivers,awlsanddrillsmustbein

contactwiththeguidearcduringuse.

NOTE:BiometSpinedoesnotrecommendfreehanding

Solitaire™-Cscrews.

11

Selecttheinserterguide(openorslim)thatcorresponds

tothefinalimplantsizetobeused.Eachimplantwidthand

heighthasacorrespondingguidetipwhichiscolor-coded

tomatchaparticularspacerheight.Thereisastoponone

sideoftheinserterguidetofacilitateplacingthespacer

ata2.0mmcountersinkrelativetotheanteriorfaceofthe

vertebralbody.Thestopcanbeorientedinasuperioror

inferiordirectionbasedonsurgeonpreference.

Attachtheinserterguidetotheinserterhandlebythreading

thedistaltipoftheinserterhandlecompletelythroughthe

threadedholeoftheinserterguide.Theinserterguidewillbe

looseontheinserterhandleuntilthespacerisattached.

Alignthespacertotheinserterguide.Sincetheimplant

andtheinserterguidearebothrotationallysymmetric,

thesuperiorandinferiorsurfacesofbothdevicesare

interchangeable.Turntheinserterhandletothreadtheinner

shaftintothethreadedholeinthecenterofthespaceruntil

theassemblyisrigid.

O.R. Tip:Confirmproperorientationofguidetoimplantby

insertingadriverwithacenteringsleeveoptiondownoneof

theinserterguidetubes.Theinstrumentshouldeasilyseat

intotheguidewithnomanipulation.

Autograft Packing

Oncetheimplantisattachedtotheinserter,fillthecavitywith

autograft.Thegraftpackingcaddycanbeused.

12


Step 5: Implant Insertion

Impacttheimplantintothefusionsitebystrikingthe

proximalendoftheinserterhandle.Theslidehammerwith

adaptercanalsobeusedforinsertion.

EachimplantcontainstwoTantalummarkers1.0mmfrom

theposteriorwalloftheimplantthatcanbeusedasa

referencewhenusingfluoroscopy.

Additionally,theSolitaire™-CSpacerincorporatesauniquely

designedtitaniumbandaroundthespacerwhichassistswith

radiographicvisualizationatthefusionsite.

Releaseanydistractorsinusetoensurethattheimplantis

fullyengagedwithendplates.

Step 6: Screw Hole Preparation

Avarietyofdrills,awlsandcenteringsleevesareavailable

toaidinscrewholepreparationinordertomeet

anatomicalchallenges.

Awl and Drill Options

Straightawlsandstraightdrillsareavailablein12mm,14mm

and15mmlengthsandcorrespondtoequivalentscrew

lengths.Likethescrews,drilldepthismeasuredinthelateral

viewfromtheanteriorfaceofthespacertothetipofthedrill

orawl.Severalguidesleeveoptionsareavailablefordrills

aswellasawls.Additionally,drillsandawlsarecolor-coded

toaidininstrumentidentificationandensureproperdepth.

Straightdrillsandawlsarecolor-codedtomatchscrew

length.Angleddrillbitshavetheirowncolor-codingscheme.

12mm 14mm 15mm

Screws LightGreen Gold LightMagenta

Straight Drill LightGreen Gold LightMagenta

Straight Awl LightGreen Gold LightMagenta

Angled Drill Bit Silver Gold DarkGray

13

Thestraightdrill,straightawlandangledawl(45°)are

designedtoconnectdirectlytothequickconnecthandle.

Theangleddrillbitmustbeattachedtothefixedangledriver

(45°).Thisdrivermateswiththequickconnecthandle.

Toattachtheangleddrillbittothefixedangledriver(45°),

lineupthemalesquareofthedriverwiththefemalesquare

withinthebit.Whenthesquaresarealigned,themalesquare

onthedriverwillsitdeeperinthebit.Oncethesquaresare

aligned,applyforcetoseatthecantileverspringsonthebit

overtheretentionbumponthedriver.Theangleddrillbitwill

beretainedonthefixedangledriver(45°)untilitisremoved

withthefixedangledbitremoverasdescribedlaterin

thetechnique.

Angled Drill Bit Fixed Angled Driver (45°)

NOTE:Theoutersleevemustbeassembledontotheinner

shaftofthefixedangledriver(45°).Slidetheoutersleeve

overtheinnershaftandseatthefemalehexoverthemale

hexpriortoattachingthehandle.

Angled Awl

Anangledawlisavailableina12mmlengthandisnot

color-coded.Itdoesnotrequireanadditionalguidesleeve.

Thereisahardstopbetweentheawlandtheinsideofthe

faceplateonthespacer.

Theangledawlhasalaseretchedmarkingthatdisappears

insidetheinserterguidewhentheawlisfullyseatedinthe

spacerandatthecorrectdepth.

14


Centering Sleeve Options

Thefollowingcombinationsofdrills,awls,andsleevesareavailable:

Stra

ight

Aw

l

Stra

ight

Dril

l

Angl

ed D

rill B

it w

hich

atta

ches

to th

e F

ixed

Ang

le D

river

Drill/Awl Sleeve

X X


X X

Tip with Malleable Shaft (For Angled Drill. Must be used with Slim Inserter Guide.)

X

Short Centering Tip* (For Angled Drill. Must be used with slim inserter guide.)

X

NOTE:Allguidetubesortipsmustberemovedbeforescrewinsertion.

NOTE:Drillandawloptionsareusedwithcenteringsleevestoaidinscrewholepreparation.

*Specialorderinstrument

Drill/Awl Sleeve

Thissleeveisplaceddirectlyintoeitherstyleinserterguide

afterimplantinsertion.Straightawlsanddrillscanbeused

withthisinstrument.Bothhaveapositivehardstopjust

belowthecolor-codedbossthatcontactsthetopofthis

sleeve.Thissleevehasalaseretchedmarkingthatdisappears

insidetheinserterguidewhenitisfullyseatedinthespacer

andatthecorrectdepth.


Thissleeveisintendedtobepre-attachedtostraightdrills

andawlspriortoinsertionintotheinserterguide.Both

straightdrillsandawlshaveabumpmid-wayalongtheshaft.

Toproperlyattachthespringsleeve,slidethesleeveontothe

straightdrillorawluntilthecantileverspringsonthespring

sleeveslideoverthebump.Nowthespringsleeveisretained

onthestraightdrillorawl.Toremovethesleeve,slideitover

thebumpintheoppositedirection.

Standarddrillsandawlshaveapositivehardstopjustbelow

thecolor-codedbossthatinteractswiththisguidetube.This

sleevehasalaseretchedmarkingthatdisappearsinsidethe

inserterguidewhenitisfullyseatedinthespacerandatthe

correctdepth.

Tip with Malleable Shaft for Angled Drill

Thetipwithmalleableshaftcanbeusedwithanystraightawl

ordrilloptionbutisprimarilyusedwiththeangleddrillbits.

Itisintendedtobeplaceddirectlyintotheinserterguideprior

toinsertingadrill.Ithasamalleablenitinolhandlethatcan

bepositionedtohelpavoidanatomicalchallenges.Angled

drillshaveavisiblehardstopthatcontactsthetopofthis

guide.Straightdrillsandawlshaveaninternalstop.

O.R. Tip:Whenusingthetipwithmalleableshaft,it

maybehelpfultoplaceitintotheinserterguideprior

toimplantinsertion.

15

16


Thefollowingdriveroptionsareavailable:

Threaded Screw Inserter

Thethreadedscrewinserterallowsforarigidscrew

attachmenttotheinserter.Theinternalthreadatthedistal

endoftheinsertermateswiththeexternalthreadonthehead

ofthescrew.Thethreadedscrewinserterisself-centering

whenusedwiththeslimguides.Ifusingtheopenguide,the

screwinsertershouldcontacttheguidearcasthescrewis

advancedtoensureproperscrewplacement.

Auto-centering Driver

Thisisastab-and-grabdriver.Ithasanincreasedshaft

diameteratthedistalendoftheDriver.Thisincreased

diameterworkswiththesliminserterguidetohelpensure

thatthescrewheadisproperlycenteredasitentersintothe

titaniumfaceplateofthespacer.Ifusingtheopenguide,the

auto-centeringdrivershouldcontacttheguidearcasthe

screwisadvancedtoensureproperscrewplacement.

Short Centering Tip for Angled Drill

Thecenteringtipisusedwiththeangleddrillbits.Itis

intendedtobeplaceddirectlyintothesliminserterguide

priortoinsertingadrill.Theangleddrillshaveavisiblehard

stopthatcontactsthetopofthisguide.Thecenteringtipalso

hasasmallholeattheproximalendofthetiptoaccepta

suturewhichwillaidinremovalafteruse.Asutureshouldbe

placedintheloopoftheshortcenteringtippriortouse.

NOTE:Theshortcenteringtipisnotapartofthekit,butis

availableasaspecialorderitemonly.

Screw Driver Options

Multiplescrewdriveroptionsareavailabletoaidinscrew

placementandhelpmeetsurgeonneedsandpreferences.All

drivershaveahexalobeinterfaceatthedistaltipandaquick

connectgeometryattheproximalendwhichengageswitha

quickconnecthandleortorquelimitinghandle.Alldriversare

compatiblewithboththeopenandsliminserterguides.

NOTE:Whenusingtheopeninserterguide,ensurethe

driverisincontactwiththearcoftheguideasthescrew

isadvanced.

17

Driver Sleeve

Driver Spring Sleeve

Driver for Sleeves

Thisdriverisastab-and-grabdriverthatisusedwith

sleevestohelpensurethatthescrewisenteringthetitanium

faceplateofthespacercenteredandatthepropertrajectory.

Boththedriverandthesleeveshavedarkgraycolor-coding

tohelpdifferentiatethemfromthedrill/awlsleevesand

denotethattheyshouldbeusedtogether.Likethedrilland

awlsleeves,thisdrivercanbeusedwiththedriversleeveor

thedriverspringsleeve.Thedriversleeveisplaceddirectly

intotheinserterguide.Thedriverforsleevescanthenbe

passeddownthissleevetoinsertthescrew.Alternatively,

thedriverspringsleeveisintendedtobepre-attachedtothe

driverforsleevespriortoinsertionintotheinserterguide.

Thestraightdriverforsleeveshasabumpmid-wayalong

theshaft.Toproperlyattachthedriverspringsleeve,slide

thesleeveontothedriveruntilthecantileverspringsonthe

springsleeveslideoverthebump.Nowthespringsleeveis

retainedonthedriver.Toremovethesleeve,slideitoverthe

bumpintheoppositedirection.

Driver Sleeve Family

Includes:

- DriverSleeve

- DriverforSleeves

- DriverSpringSleeve

18


Non-Retaining Driver

Thisdriverdoesnotfrictionallylocktothescrewsand

hasagoldtiptohelpdenotethatitisnotintendedtobe

stab-and-grab.Becauseitisnotastab-and-grab,this

driversitsdeeperintothescrew’shexalobedrivegiving

thedriver-to-screwinterfacemorestrength.Italsohasa

decreasedshaftdiameteratthedistalendofthedriver.

Thisallowsforadditionalversatilitywhichmaybe

necessaryduringscrewremovalorrevisioncases.

O.R. Tip:Allgold-tipdriversarenotintended

tobestab-and-grab,andwillnotretainthescrew.

Thegold-tipdriversareintendedforfinaltightening

orremoval.

O.R. Tip:Usinganon-retainingdriverduringfinaltightening

andscrewremovalcanreducethechanceofstrippingthe

screworthedriver.

Fixed Angle Driver (45°) and Angled Driver Bits

Thisangleddriveroptionhasastab-and-grabscrewinterface

aswellasarigidfixedangletoaidinscrewplacementand

helpaddressanatomicalchallengeswhichcanbefoundinthe

upperandlowerregionsofthecervicalspine.Driverbitsare

intendedtoattachtothefixedangleddriver.Todoso,lineup

themalesquareofthedriverwiththefemalesquarewithin

thebit.Whenthesquaresarealignedthemalesquareonthe

driverwillsitdeeperinthebit.Oncethesquaresarealigned

applyforcetoseatthecantileverspringsonthebitoverthe

retentionbumponthedriver.Thebitwillberetainedonthe

driveruntilitisremovedusingthebitremoverdescribedlater

inthistechnique.

Flexible Driver

Thisalternateangleddriveroptionhasastab-and-grabscrew

interfaceaswellasrobustflexiblelinks.Thisinstrument

contourstotheanatomyandhelpsaddressanatomical

challengeswhichcanbefoundintheupperandlowerregions

ofthecervicalspine.

19

Non-Retaining Flexible Driver

Thisdrivercombinesthebenefitsoftheflexibledriverwith

theversatilityofthenon-retainingdriver.Itisnotintendedto

beastab-and-grabdriver(goldtip),asitdoesnotfrictionally

engagewiththescrew.

Step 7: Screw Insertion

Reminder:Screwsareplacedatafixedtrajectoryof35°

cephalad/caudalandhavea7°medialconvergence.Theslim

guideswillfacilitatethistrajectory.Whenusingtheopen

guides,ensuretheinsertershaftremainsincontactwiththe

guidearctoensurethepropertrajectory.

Attachthequickconnecthandletothedesireddriveror

threadedscrewinserter.

Whenusingastab-and-grabdriver,affixthedesiredsize

screwtothedriverbyseatingthedistaltipofthedriverinto

thehexalobeonthescrewhead.Placethescrewintothe

appropriatescrewholethroughtheinserterguide.Inserteach

screwuntilsolidengagementofthecancellousthreadoccurs.

Repeatforthecontralateralhole.

When using the threaded screw inserter

Affixthedesiredsizescrewtothethreadedscrewinserterby

turningthescrewclockwisetomatetheexternalthreadon

thescrewheadwiththeinternalthreadofthescrewinserter

untilthescrewbottomsout.Insertthehexalobeonthedistal

tipoftheinserterintotheheadofthescrew.

Placethescrewintotheappropriatescrewholethrough

theinserterguide.WhileholdingtheT-handleofthescrew

insertersteady,turnthestraightquick-connecthandle

clockwisetoadvancethescrewoutofthesleeveandinto

thefaceplateofthespaceruntilsolidengagementofthe

cancellousthreadoccurs.Repeatforthecontralateralhole.

20


Step 8: Final Tightening

Attachthetorquewrenchhandletothedesireddriverand

insertthetipofthedriverintothehexalobedriveofthe

screw.Turnthehandleuntilanaudible“click”isheardat

(aminimumof)14in.-lbs.oftorque.

O.R. Tip:Theinserterguideshouldremainengaged

duringscrewinsertionandfinaltighteningtoserveas

acountertorque.

O.R. Tip:Torquewrenchcanbeattachedtothedriveratthe

beginningofthescrewinsertionprocess,ifpreferred,so

thereisnoneedtoswitchhandles.

NOTE:Biometdoesnotrecommendusingthefixedangle

driverforfinaltightening.Anyotherdriveroption(including

theflexibledriver)canbeusedforfinaltorquing.

Step 9: Inserter Guide Removal

Turntheinserterguidehandlecounterclockwiseuntilit

disengagesfromthespacer.Thetipwillbelooseontheshaft

butwillberetainedontheshaft.

21

Removal

Angled Driver Bit Removal

Thedriverbitand/ordrillbitsplacedonthefixedangledriver

shouldberemovedusingtheangleddriverbitremover.To

removeabit,lineupthelaseretchedlinesonthebitremover

andfixedangledriverhousing.Then,placethebitthrough

thecustomtipsoftheremoveruntilthefaceofthetips

contactthehousingofthefixedangledriver.Squeezethe

handlesoftheremovertodisengagethebit.

Implant Removal

ShoulditbecomenecessarytoremovetheSolitaire™-C

Spacer,thefollowingguidelinesshouldbeobserved:

• Removalfollowsthereverseorderofimplantation

• Softtissueontheanteriorsurfaceoftheimplant shouldberemoved

• Assembletheimplantremoverbyplacingtheinnershaft intotheimplantremover

• Attachtheimplantremovertotheimplantbyturning theknobclockwisetothreadtheinnershaftintothe

centerfixationholeonthespacer.Theflatsonthe removeraretobeparalleltotheinferiorandsuperiorsurfacesoftheimplant.

• Removethescrewsusingascrewdriver

• Oncescrewsareremoved,removeimplantfromwound site.Theslottedmalletorslidehammerwithadaptercan

beusedtoaidinimplantremovalifnecessary.Ifusingtheslidehammer,threadtheadaptertothedistalendoftheslidehammer.Thenslidetheadapterovertheproximalendoftheremover.

22

Ordering Information

Solitaire™-C Small-Medium Lordotic Implant Kit

(Catalog No. 14-531504)

Catalog # Description Qty/Set

14-520506 6Hx14Wx12DLordoticSpacer 2










Solitaire™-C Small-Medium Parallel Implant Kit

(Catalog No. 14-531505)


14-520706 6Hx14Wx12DParallelSpacer 2










23

Solitaire™-C Large Lordotic and Parallel Implant Kit

(Catalog No. 14-531506)












Solitaire™-C Screws (Catalog No. 14-531500)

Included in Standard Instrument and Screw Kit


14-531712 3.5mmx12mmScrew 6

14-531714 3.5mmx14mmScrew 6

14-531715 3.5mmx15mmScrew 6

14-531722 3.75mmx12mmScrew 6

14-531724 3.75mmx14mmScrew 6

14-531725 3.75mmx15mmScrew 6

24

Ordering Information (Continued)

Solitaire™-C Standard Instrument and Screw Kit

(Catalog No. 14-531500)


14-520635 InserterHandle 2

14-531563 Mallet 1

14-531565 QuickConnectHandle 2

14-531593 Drill/AwlSleeve 2

14-531594 Spring-LoadedDrill/AwlSleeve 2

14-531602 12mmAwl** 2

14-531604 14mmAwl** 2

14-531605 15mmAwl** 2

14-531612 12mmDrill** 2

14-531614 14mmDrill** 2

14-531615 15mmDrill** 2

14-531571 DriverSleeve 2

14-531572 DriveSpringSleeve 2

14-531574 DriverforSleeves 2

14-531575 Auto-CenteringDriver 1

14-531576 Non-RetainingDriver 1

14-531577 ThreadedScrewInserter 1

14-531578 TipwithMalleableShaft 2

14-531579 ShortCenteringTip* 0

14-531581 FixedAngleDriver(45°) 2

14-531582 AngledDriverBit 2

14-531632 12mmAngledDrillBit** 2



14-531583 FixedAngledBitRemover 1

14-531702 12mmAngledAwl** 2

14-531585 FlexibleDriver 1

14-531586 Non-RetainingFlexibleDriver 1

14-531588 TorqueWrench 1

14-531590 ImplantRemover 1

14-531561 InnerShaft 1

14-531591 SlideHammer 1

14-531592 SlideHammerAdapter 1

14-531595 GraftPackingCaddy 1

*DenotesSpecialOrderItem

**DenotesSingleUseOnly

Solitaire™-C Standard Instrument and Screw Kit

(Catalog No. 14-531500) (Continued)


14-520636 14Wx6HSlimGuideTip 1















14-520666 14Wx6HOpenGuideTip 1















25

Solitaire™-C Small-Medium Lordotic Rasp and Trial Kit

(Catalog No. 14-531501)


14-531890 5/6Hx14Wx12DLordoticRasp(w/oStops) 1






14-531750 5/6Hx14Wx12DLordoticTrial(w/oStops) 1






14-531830 5/6Hx14Wx12DLordoticRasp(withStops) 1






14-531640 5/6Hx14Wx12DLordoticTrial(withStops) 1






26

Ordering Information (Continued)

Solitaire™-C Small-Medium Parallel Rasp and Trial Kit

(Catalog No. 14-531502)


14-532140 5/6Hx14Wx12DParallelRasp(w/oStops) 1






14-532020 5/6Hx14Wx12DParallelTrial(w/oStops) 1






14-532080 5/6Hx14Wx12DParallelRasp(withStops) 1






14-531960 5/6Hx14Wx12DParallelTrial(withStops) 1






27

Solitaire™-C Large Lordotic, Parallel Rasp and Trial Kit

(Catalog No. 14-531503)


























28

Indications and Contraindications

Indications for Use

TheSolitaire™-CCervicalSpacerSystemisindicatedfor

stand-aloneanteriorcervicalinterbodyfusionprocedures

inskeletallymaturepatientswithcervicaldegenerativedisc

diseaseatonelevelfromC2toT1.Cervicaldegenerative

discdiseaseisdefinedasintractableradiculopathyand/or

myelopathywithherniateddiscand/orosteophyteformation

onposteriorvertebralendplatesproducingsymptomatic

nerverootand/orspinalcordcompressionconfirmedby

radiographicstudies.TheSolitaire™-CCervicalSpacerSystem

istobeusedwithautograftandimplantedviaananterior

approach.TheSolitaire™-CCervicalSpacermustbeimplanted

withtheSolitaire™-CTitaniumScrewsthatarepartofthe

system.Thiscervicaldeviceistobeusedinpatientswho

havehadsixweeksofnon-operativetreatment.

Contraindications

Contraindicationsinclude,butarenotlimitedto:

1. Infection,systemic,spinalorlocalized

2. Morbidobesity

3. Signsoflocalinflammation

4. Feverorleukocytosis

5. Metalsensitivity/allergiestotheimplantmaterials

6. anymedicalorsurgicalconditionwhichwouldpreclude

thepotentialbenefitofspinalimplantsurgery,suchas

theelevationofsedimentationrateunexplainedbyother

diseases,elevationofwhitebloodcount(WBC),ora

markedleftshiftintheWBCdifferentialcount

7. Grosslydistortedanatomydueto

congenitalabnormalities

8. Rapidjointdisease,boneabsorption,osteopenia,and/or

osteoporosis(osteoporosisisarelativecontraindication

sincethisconditionmaylimitthedegreeofobtainable

correction,theamountofmechanicalfixation,and/orthe

qualityofthebonegraft)

9. Anycasenotneedingabonegraftandfusionorwhere

fracturehealingisnotrequired

10. Anypatienthavinginadequatetissuecoverageoverthe

operativesite

11. Anypatientunwillingtocooperatewith

thepostoperativeinstructions

12.Priorfusionatthelevel(s)tobetreated.

Warnings

Thesurgeonshouldbeawareofthefollowing:

1. Thecorrectselectionoftheimplantisextremely

important.Thepotentialforsuccessisincreasedbythe

selectionofthepropersize,shapeanddesignofthe

implant.Thesizeandshapeofthehumanspinepresents

limitingrestrictionsofthesizeandstrengthofimplants.

2. Thesurgeonmustensurethatallnecessaryimplants

andinstrumentsareonhandpriortosurgery.Thedevice

mustbehandledandstoredcarefully,protectedfrom

damage,includingfromcorrosiveenvironments.They

shouldbecarefullyunpackedandinspectedfordamage

priortouse.

3. Allinstrumentsmustbecleanedandsterilizedprior

tosurgery.

4. Donotreuseimplants/devices.Whileanimplant/device

mayappearundamaged,previousstressmayhave

createdimperfectionsthatwouldreducetheservice

lifeoftheimplant/device.

5. Donottreatpatientswithimplants/devicesthathavebeen

evenmomentarilyplacedinorusedonadifferentpatient.

6. Properimplantselectionandpatientcomplianceto

postoperativeprecautionswillgreatlyaffectsurgical

outcomes.Patientswhosmokehavebeenshownto

haveanincreasedincidenceofnonunion.Therefore,

thesepatientsshouldbeadvisedofthisfactand

warnedofthepotentialconsequences.

29

7. Postoperativecareisimportant.Thepatientshouldbe

instructedinthelimitationsofhis/herimplantandshould

becautionedregardingweightbearingandbodystress

ontheappliancepriortosecurebonehealing.

8. Patientswithpreviousspinalsurgeryatthelevel(s)tobe

treatedmayhavedifferentclinicaloutcomescomparedto

thosewithoutaprevioussurgery.

9. TheSolitaire™-CSpacermustbeimplantedwiththe

Solitaire™-CTitaniumscrewsthatarepartofthesystem.

10. TheSolitaire™-CCervicalSpacerSystemhasnot

beenevaluatedforsafetyandCompatibilityinthe

MRenvironment.TheSolitaire™-CCervicalSpacer

Systemhasnotbeentestedforheatingormigration

intheMRenvironment.

Precautions

Preoperative:

1. Onlypatientsthatmeetthecriteriadescribedinthe

indicationsshouldbeselected.

2. Careshouldbeusedinthehandlingandstorageof

theimplantcomponents.Theimplantsshouldnot

bescratchedorotherwisedamaged.Implantsand

instrumentsshouldbeprotectedduringstorage

especiallyfromcorrosiveenvironments.

3. BiometSpineimplantsshouldnotbeusedwithimplants

orinstrumentsfromanothermanufacturerforreasonsof

metallurgy,mechanicsanddesign.

Intraoperative:

1. Anyinstructionmanualsshouldbecarefullyfollowed.

2. Atalltimes,extremecautionshouldbeusedaroundthe

spinalcordandnerveroots.Damagetonervesmayoccur

resultinginalossofneurologicalfunctions.Bonegrafts

mustbeplacedintheareatobefused.

Postoperative:

1. Thephysician’spostoperativedirectionsandwarningsto

thepatientandthecorrespondingpatientcomplianceare

extremelyimportant.

2. Detailedinstructionsontheuseandlimitationsof

thedeviceshouldbegiventothepatient.Ifpartial

weight-bearingisrecommendedorrequiredprior

tofirmbonyunion,thepatientmustbewarnedthat

bending,looseningorbreakageofthecomponentsare

complicationswhichcanoccurasaresultofexcessive

orearlyweight-bearingorexcessivemuscularactivity.

Theriskofbending,loosening,orbreakageofaninternal

fixationdeviceduringpostoperativerehabilitationmay

beincreasedifthepatientisactive,orifthepatient

isdebilitated,demented,orotherwiseunabletouse

crutchesorothersuchweightsupportingdevices.The

patientshouldbewarnedtoavoidfallsorsuddenjoltsin

spinalposition.

3. Toallowmaximumchancesforasuccessfulsurgical

result,thepatientordeviceshouldnotbeexposed

tomechanicalvibrationsthatmayloosenthedevice

construct.Thepatientshouldbewarnedofthispossibility

andinstructedtolimitandrestrictphysicalactivities,

especiallylifting,twistingmotionsandanytypeofsport

participation.Thepatientshouldbeadvisednotto

smokeorconsumealcoholduringthebonegraft

healingprocess.

4. Ifanonuniondevelopsorifthecomponentsloosen,

bend,and/orbreak,thedevice(s)shouldberevisedand/

orremovedimmediatelybeforeseriousinjuryoccurs.

Failuretoimmobilizeadelayedornonunionofbonecan

resultinexcessiveandrepeatedstressesontheimplant.

Bythemechanismoffatiguethesestressescancause

eventualbending,loosening,orbreakageofthedevice(s).

Itisimportantthatimmobilizationofthespinalsurgical

sitebemaintaineduntilfirmbonyunionisestablished

andconfirmedbyradiographicexamination.Thepatient

mustbeadequatelywarnedofthesehazardsandclosely

supervisedtoensurecooperationuntilbonyunion

isconfirmed.

30

Indications and Contraindications (Continued)

5. Anyretrieveddevicesshouldbetreatedinsuchamanner

thatreuseinanothersurgicalprocedureisnotpossible.

Aswithallorthopaedicimplants,noneoftheSolitaire-C

CervicalSpacerSystemcomponentsshouldeverbe

reusedunderanycircumstances.

Potential Adverse Effects and Complications

Possibleadverseeffectsinclude,butarenotlimitedto:

1. Bending,loosening,migrationorfractureoftheimplants

orinstruments

2. Lossoffixation

3. Sensitivitytoametallicforeignbody,includingpossible

tumorformation

4. Skinormusclesensitivityinpatientswithinadequate

tissuecoverageovertheoperativesite,whichmayresult

inskinbreakdownand/orwoundcomplications

5. Nonunionordelayedunion

6. Infection

7. Nerveorvasculardamageduetosurgicaltrauma,

includinglossofneurologicalfunction,duraltears,

radiculopathy,paralysisandcerebralspinalfluidleakage

8. Gastrointestinal,urologicaland/orreproductivesystem

compromise,includingsterility,impotencyand/orlossof

consortium

9. Painordiscomfortattheoperativeand/orbonegraft

donorsite

10. Bonelossduetoresorptionorstressshielding,orbone

fractureat,aboveorbelowthelevelorsurgery(fracture

ofthevertebra)

11.Hemorrhageofbloodvesselsand/orhematomas

12.Misalignmentofanatomicalstructures,including

lossofproperspinalcurvature,correction,reduction

and/orheight

13.Bursitis

14.Inabilitytoresumeactivitiesofnormaldailyliving

15.Reoperation

16.Death

Sterilization

Unlesssuppliedsterile,devicesmustbesterilizedprior

tosurgicaluse.Productprovidedsterileissterilizedby

exposuretoaminimumdoseof2.5Megarads(25kGy)

gammaradiation.Wherespecified,donotuseimplantsafter

expirationdate.Re-sterilizationisnotrecommended.

Forproductsuppliednon-sterile,allpackagingmaterials

mustberemovedpriortosterilization.Thefollowingsteam

sterilizationparametersarerecommended:

U.S.SterilizationParameters:

Cycle:Pre-vacuumSteam

Temperature:270°F/132°C

Time:4minutes

DryingTime:30minutes

NOTE:Allowforcooling

FDAclearedsterilizationwrapsshouldbeusedtomaintain

sterilityafterprocessing.

SterilizationParametersforUseOutsideofU.S.:

Cycle:Pre-vacuumSteam

Temperature:275°F/135°C

Time:3minutes

DryingTime:30minutes

NOTE:Allowforcooling

31

Further Information

Biometdoesnotrecommendstackingoftraysduringthe

sterilizationprocess.

Individualsorhospitalsnotusingtherecommendedmethod,

temperature,andtimeareadvisedtovalidateanyalternative

methodsorcyclesusinganapprovedmethodorstandard.

Additionalinformationaboutinstrumentation(including

assembly/disassembly)maybefoundinthesystemsurgical

technique,referenceguideand/orassociatedpackageinserts.

RefertotheBiometNon-sterileInstrumentIFUforfull

processinginstructionsforinstruments.

Forfurtherinformation,pleasecontacttheCustomer

ServiceDepartmentat:

BiometSpine

310InterlockenParkway,Suite120,

Broomfield,CO80021

303.443.7500•800.447.3625

biometspine.com

32

Notes:

C

Broomfield,CO•800.447.3625biometspine.com•BSP231088L04/14

©2014BiometSpine,LLC.Allrightsreserved.AlltrademarksarethepropertyofBiomet,Inc.oroneofitssubsidiariesunlessotherwiseindicated.PEEK-OPTIMA®isaregisteredtrademarkofInvibio®Limited.RxOnly.

AtBiomet,engineeringexcellenceisourheritageand

ourpassion.Forover25years,throughvarious

divisionsworldwide,wehaveappliedthemost

advancedengineeringandmanufacturingtechnology

tothedevelopmentofhighlydurablesystemsfora

widevarietyofsurgicalapplications.

Tolearnmoreaboutthisproduct,

contactyourlocalBiometSalesRepresentativetoday.

Solitaire™-C Cervical Spacer SystemA Zero Profile Anterior Fusion Cervical Device

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