Transmissionputty

PI–78,Rev4,08/2016RM-1479READBEFOREUSINGDBMPuttyDEMINERALIZEDBONEMATRIXDONATEDHUMANTISSUECAUTION:DEVICEISFORSINGLEPATIENTUSEONLY.
AsepticallyProcessed.
PassesUSPSterilityTests.
DBMPuttyIsNotTerminallySterilized.
DESCRIPTIONDBMPuttyisprocessedhumanbonethathasbeendemineralizedandcombinedwithsodiumhyaluronate,whichisanaturallyderivedmaterialnotofanimaloriginthatisbothbiocompatibleandbiodegradable.
Thecombinationofdemineralizedboneandsodiumhyaluronateresultsinaputty-likeortexturedconsistencyforeaseandflexibilityofuseduringsurgicalapplication.
OSTEOINDUCTIVEPOTENTIALDBMPuttyisosteoconductive,andhasbeenshowntohaveosteoinductivepotentialinanathymicmousemodel.
EverylotoffinalDBMPuttyproductistestedinanathymicmousemodelorinanalkalinephosphataseassay,whichhasbeenshowntohaveapositivecorrelationwiththeathymicmousemodel,toensuretheosteoinductivepotentialofthefinalproduct.
Standardtestingperformedinanathymicmouseoralkalinephosphataseassaymustprovepositiveforlotrelease.
Itisunknownhowtheosteoinductivepotential,measuredintheathymicmousemodelorthealkalinephosphataseassay,willcorrelatewithclinicalperformanceinhumansubjects.
INDICATIONSFORUSEDBMPuttyisintendedfortheaugmentationofdeficientmaxillaryandmandibularalveolarridgesandthetreatmentoforal/maxillofacialanddentalintraosseousdefectsincluding:-Ridgeaugmentation-Fillingofcysticdefect-Fillingofextractionsites-Fillingoflesionsofperiodontalorigin-Craniofacialaugmentation-FillingofdefectsofEndodonticorigin-Mandibularreconstruction-Repairoftraumaticdefectsofthealveolarridge,excludingmaxillaryandmandibularfracture-Fillingresectiondefectsinbenignbonetumors,benigncystsorotherosseousdefectsinthealveolarridgewallDBMPuttycanbeusedwithautograftorbonemarrowaspirate.
DBMPuttyisforsinglepatientuseonly.
CONTRAINDICATIONSDBMPuttyisNOTintendedtoprovidestructuralsupportoftheboneduringthehealingprocess.
DBMPuttyisalsocontraindicatedforincompletemaxillofacialskullgrowth.
ADVERSEEFFECTSPossibleadverseeffectsofusingDBMPuttyinclude,butarenotlimitedto:PotentiallossofcontourofmaxillofacialskullInfectionofsofttissueand/orbone(osteomyelitis)FeverDeformityoftheboneatthesiteIncompleteboneingrowth,delayedunionornon-unionHypercalcemiaortransienthypercalcemiaFractureofthenewlyformedboneDiseasetransmissionandundesirableimmuneresponseWithintheUnitedStates:AdverseoutcomesattributabletothetissuemustbepromptlyreportedtoMTF.
OutsideoftheUnitedStates:Adverseoutcomesattributabletothetissuemustbepromptlyreportedtoyourlocalrepresentative.
CAUTIONSDonotsterilize.
Donotfreeze.
DBMPuttymayextrudeintofacialsofttissue.
TraceamountsofGentamicinmaybepresent.
Tissueisexposedtoprocessingsolutionsthatmaycontaindetergentsandalcohol.
Traceamountsofprocessingsolutionmayremain.
Cautionshouldbeexercisedifthepatientisallergictoanyofthesesubstances.
NOTE:No-lactamantibioticsareusedduringtheprocessingoftissueinDBMPuttyproducts.
ExtensivemedicalscreeningprocedureshavebeenusedintheselectionofalltissuedonorsforMTF(pleaseseeDonorScreeningandTesting).
TransmissionofinfectiousdiseasessuchasHIVorhepatitis,aswellasatheoreticalriskoftheCreutzfeldt-Jakob(CJD)agent,mayoccurinspiteofcarefuldonorselectionandserologicaltesting.
Closedsuctionordrainageisrecommendedtopreventfluidaccumulationinthewound.
Cautionshouldbetakenforthefollowingcircumstances:SeverevascularorneurologicaldiseaseFeverUncontrolleddiabetesPregnancyHypercalcemiaRenal-compromisedpatientsHistoryoforactivePott'sdiseaseOsteomyelitisatthesurgicalsiteSepsisinoraroundthesurgicalsiteInabilitytocooperatewithand/orcomprehendpost-operativeinstructionsDEVICEINFORMATIONDBMPuttyiscomposedofDemineralizedBoneMatrixandsodiumhyaluronate.
Thedemineralizedboneallograftinthisproductispreparedfromtissueprocuredfromadeceaseddonorusingasepticsurgicaltechniques.
TheboneusedinthePuttyiscorticalbone.
ThesetissuesweretreatedwithGentamicinandwerecleanedusingethanolandwashedwithpurifiedwater.
Thebonewasdemineralizedusinghydrochloricacid.
Thedemineralizedbonewasthenlyophilizedtoacontrolledmoisturecontent.
Thedemineralizedbonewascombinedwithsterile-filteredsodiumhyaluronatepriortopackaging.
Sodiumhyaluronateisanaturallyderivedmaterialthatisbiocompatibleandbiodegradable.
ThesodiumhyaluronateismixedinaphosphatebufferedsalineandisaddedtothedemineralizedbonetoaidinmaintainingphysiologicalpHaswellastoimprovethehandlingcharacteristicsofdemineralizedbone.
Sometissuesaretreatedwithlow-dosegammaradiation.
Forthesetissuesthecontainerlabelwillstate,"TreatedwithGammaRadiation.
"SamplesfromeachdonorlotofDBMPuttyweretestedandshowednoevidenceofmicrobialgrowth,complyingwiththerequirementsofUSPSterilityTests.
THISTISSUEWASRECOVEREDFROMADECEASEDDONORFROMWHOMLEGALAUTHORIZATIONORCONSENTHASBEENOBTAINED.
THISRECOVERYWASPERFORMEDUSINGASEPTICTECHNIQUES.
PROCESSINGANDPACKAGINGWEREPERFORMEDUNDERASEPTICCONDITIONS.
TERMINALSTERILIZATIONAGENTSWERENOTUSEDINTHEPROCESS.
DBMPuttyComponentsSizeBoneParticleDiameter212–850mSodiumhyaluronatecontent(byweightinsolution)4%Bonecontent(byweight)31%INSTRUCTIONSFORUSEDBMPuttyispackagedinaglasssyringeandmustbeextrudedintoasterilebasin,notdirectlyintotheoperativesite.
THESYRINGEISNOTANAPPLICATOR.
Careshouldbetakentoapplygentle,evenforcetotheplungerwhenextrudingDBMPuttyfromthesyringe.
Extremeforceappliedtotheplungermaycausetheglasssyringetobreak.
NOTE:Thisallografthasbeenasepticallypackagedintosterilizedpackagingcomponents.
Tomakereadyforuse,openthepackageusingaseptic/steriletechniques.
1.
Peelbacklidofoutertray.
2.
Passinnertraytosterilefield.
3.
Peelbacklidofinnertray.
4.
Removesyringefrominnertray.
5.
Removeprotectivecapfromendofsyringe.
6.
ExtrudeDBMPuttyintoasterilebasin.
7.
ShapeanduseDBMPuttyaspersurgeon'spreference.
DBMPuttycanbeusedaloneormixedwithautogenousbone(1:1ratiobyvolume)orwithbonemarrowaspirate(2.
0mL/2.
8gofDBMPuttyor2.
0cc/2.
8ccofDBMPutty).
Disposeofexcessorunusedtissueandallpackagingthathasbeenincontactwiththetissueinaccordancewithrecognizedproceduresfordiscardingregulatedmedicalwastematerials.
DONORSCREENING&TESTINGPriortodonation,thedonor'smedical/socialhistoryisscreenedformedicalconditionsordiseaseprocessesthatwouldcontraindicatethedonationoftissuesinaccordancewithcurrentpoliciesandproceduresapprovedbytheMTFMedicalBoardofTrustees.
DonorbloodsamplestakenatthetimeofrecoveryweretestedbyafacilitythatisCLIAcertifiedandregisteredwiththeFDA.
Thedonorbloodsamplesweretestedfor:HepatitisBsurfaceantigenHIV-1/2antibodyHepatitisBcoreantibodySyphilisHepatitisCantibodyHBV(NAT)HIV-1(NAT)HCV(NAT)Allinfectiousdiseasetestswerenegative.
Thisallografttissuehasbeendeterminedtobesuitablefortransplantation.
Theinfectiousdiseasetestresults,consent,currentdonormedicalhistoryinterview,physicalassessment,availablerelevantmedicalrecordstoincludepreviousmedicalhistory,laboratorytestresults,autopsyandcoronerreports,ifperformed,andinformationobtainedfromanysourceorrecordswhichmaypertaintodonorsuitability,havebeenevaluatedbyanMTFphysicianandaresufficienttoindicatethatdonorsuitabilitycriteriacurrentatthetimeofprocurement,havebeenmet.
Thistissueissuitablefortransplantation.
ThedonorsuitabilitycriteriausedtoscreenthisdonorareincompliancewiththeFDAregulationspublishedin21CFRPart1271HumanCells,Tissues,andCellularandTissueBasedProducts,asapplicable.
Allproceduresfordonorscreening,serologicandmicrobiologictesting,meetorexceedcurrentstandardsestablishedbytheAmericanAssociationofTissueBanks.
VIRALCLEARANCEANDINACTIVATIONApanelofmodelpotentialhumanvirusesrepresentingvariousvirustypes,sizes,shapesandgenomeswereevaluated.
Theviralinactivationtestingdemonstratedsuitableviralinactivationpotentialoftheprocessingmethodforawidespectrumofpotentialhumanviruses.
TheDBMPuttyprocessfurtherreducestheriskofviralcontaminationbeyonddonortestingandscreeningprocedures.
PACKAGING&LABELINGDBMPuttyisasepticallypackagedinasterilizedsyringe.
ThesyringecontainingDBMPuttyisinsidetwosterilizedplastictrays,eachsealedwithfoillids.
Theoutertrayislabeledandthenputinabox.
Thisallograftmustnotbeusedunderanyofthefollowingcircumstances:Ifthecontainersealisdamagedornotintactorhasanyphysicaldamage;Ifthecontainerlabeloridentifyingbarcodeisseverelydamaged,notlegibleorismissing;orIftheexpirationdateshownonthecontainerlabelhaspassed.
STORAGEStoreDBMPuttyatambienttemperature.
Norefrigerationorfreezingisrequired.
Itistheresponsibilityofthetransplantfacilityorcliniciantomaintainthetissueintendedfortransplantationintheappropriaterecommendedstorageconditionspriortotransplant.
PATIENTRECORDTissuerecipientrecordsmustbemaintainedbytheconsigneeandtransplantfacilityforthepurposeoftracingtissuepost-transplantation.
ATissueTraceTrackingFormandpeel-offstickershavebeenincludedwitheachpackageoftissue.
Theserialnumberandthetissuedescriptionhavebeenpreprintedonthepeel-offstickers.
PleaserecordthepatientID,nameandaddressofthetransplantfacility,allografttissueinformation(usingthepeel-offstickers),andcommentsregardingtheuseofthetissueontheTissueTraceTrackingForm.
AlternativelyasystemforelectronicsubmissionmaybeusedandsenttoMTFTTC@Sceris.
com.
WithintheUnitedStates:Oncecompleted,thebottompageoftheformshouldbereturnedtoMTFusingtheself-addressedmailer.
Copiesofthisinformationshouldberetainedbythetransplantfacilityforfuturereference.
OutsideoftheUnitedStates:Oncecompleted,thebottompageoftheformshouldbereturnedtothelocalallograftrepresentativeorprovider.
Copiesofthisinformationshouldberetainedbythehospitalforfuturereference.
Reference:CurrentMTFpoliciesandproceduresareincompliancewithcurrentFDA,AATBandotherregulatoryrequirements.
DefinitionsofLabelSymbolsSeeIFUDoNotReuseProcessedby:125MayStreetEdison,NJ08837USAWithintheUnitedStates:1.
800.
433.
6576OutsidetheUnitedStates:+1.
732.
661.
0202Allrecovery,processinganddistributioncostswerepaidforbyMTF,anon-profitorganization.
CAUTION:Federal(US)lawrestrictsthisdevicetosale,distributionandusebyorontheorderofaphysicianordentist.
Pleasenote:Humantissuefortransplantationshallnotbeoffered,distributedordispensedforVeterinaryUse.
MTFtissueformsandproductsareprotectedbyoneormoreissuedorlicensedUnitedStatespatents.
AlistofpatentsonavailabletissuesandrelatedtechnologiesmaybefoundontheMTFwebsitewww.
mtf.
org.
MTFMusculoskeletalTransplantFoundationandTissueTraceareregisteredtrademarksoftheMusculoskeletalTransplantFoundation,Edison,NJUSA.
2016MusculoskeletalTransplantFoundation.
CTO:100024