FlexHD® PLIABLETM Acellular Dermis

1 PATIENT RECORDT issue recipient records must be maintained by the consignee andtransplant facility for the purpose of tracing tissue posttransplantation. This will allow MTF to facilitate the investigationof actual or suspected transmission of communicable disease andtake appropriate and timely corrective action. A TissueTrace Tracking Form and peel-off stickers have been included with eachpackage of tissue. Please record the patient ID, name and addressof the transplant facility, allograft tissue information (using thepeel-off stickers) and comments regarding the use of the tissue onthe TissueTrace Tracking a system forelectronic submission may be the United States:Once completed, the bottom page of the form should be returned toMTF using the self-addressed, postage paid mailer.

2 Copies of thisinformation should be retained by the transplant facility for of the United States:Once completed, thebottom page of the form should be returned to the local allograftrepresentative or provider. Copies of this information should beretained by the hospital for future :Current MTF policies and procedures in compliancewith current FDA, AATB and other regulatory of Label SymbolsSee IFUDo Not ReuseProcessed By:125 May StreetEdison, NJ 08837 USAW ithin the United States: of the United States: recovery, processing and distribution costs were paid for by MTF, anon-profit : Restricted to use by a physician, dentist tissue forms and products are protected by one or more issued orlicensed United States patents.

3 A list of patents on available tissues andrelated technologies may be found on the MTF web site PLIABLE is a trademark of Musculoskeletal Transplant Foundation is a registeredtrademark of the Musculoskeletal Transplant Foundation, Edison, : 100024PI 76 Rev 1, 03/2012RM 1827 READ BEFORE USINGFlexHD PLIABLETMA cellular DermisDONATED HUMAN TISSUECAUTION: TISSUE IS FOR SINGLE PATIENT Processed. Passes USP <71> Sterility PLIABLE Is Not Terminally Sterilized. Do PLIABLE is human allograft skin minimally processed toremove dermal cells and is packaged in an ethanol PLIABLE tissue is processed from deep cut tissue fromwhich the epidermal layer has been physically removed.

4 Theprocess utilized preserves the extracellular matrix of the resulting allograft serves as a framework to support cellularrepopulation and vascularization at the surgical FOR USEFlexHD PLIABLE is processed to remove cells while maintainingthe integrity of the matrix with the intent to address the issues ofthe specific and nonspecific inflammatory responses. It is used forthe replacement of damaged or inadequate integumental tissue orfor the repair, reinforcement or supplemental support of soft tissuedefects. FlexHD PLIABLE should not be used for AbdominalWall Repair, Hernia Repair or other procedures in whichsubstantial tensile strength is needed.

5 In those instances, FlexHD should be EFFECTSP ossible adverse effects of using human skin include but are notlimited to: Local or systemic infection Dehiscence and/or necrosis due to poor revascularization Specific or nonspecific immune response to some componentof the graftWithin the United States: Adverse outcomes attributable to thetissue must be promptly reported to of theUnited States: Adverse outcomes attributable to the tissue mustbe promptly reported to your local applied properly, FlexHD PLIABLEhas been shown tosupport the migration of host cells from wound margins andsurrounding that could potentially inhibitintegration of FlexHD PLIABLE include, but are not limited to.

6 Fever Uncontrolled diabetes Pregnancy Low vascularity of the surrounding tissue Local or systemic infection Mechanical trauma Poor nutrition or poor general medical conditionTHIS TISSUE WAS RECOVERED FROM A DONORWITH DOCUMENTED PERMISSION FOR RECOVERYAND DONATION. THIS RECOVERY WASPERFORMED USING ASEPTIC AND PACKAGING WERE PERFORMEDUNDER ASEPTIC CONDITIONS. TERMINALSTERILIZATION AGENTS WERE NOTUSED IN THEPROCESS. Dehiscence and/or necrosis due to poor revascularization Inability to cooperate with and/or comprehend post-operativeinstructions Infected or nonvascular surgical sitesCAUTIONSDo not sterilize.

7 Do not known sensitizing agents arepresent in this tissue. FlexHD PLIABLE is packaged in an ethanolsolution and must be soaked in a sterile solution prior toimplantation. Care should be taken when using FlexHD PLIABLEin conjunction with electrical equipment. NOTE: No -lactamantibiotics are used during the processing of tissue in PLIABLE should not be used for Abdominal Wall Repair,Hernia Repair or other procedures in which substantial tensilestrength is needed. In those instances, FlexHD should be medical screening procedures have been used in theselection of all tissue donors for MTF (please see Donor Screeningand Testing).

8 Transmission of infectious diseases such as HIV orhepatitis, as well as a theoretical risk of the Creutzfeldt-Jakob(CJD) agent, may occur in spite of careful donor selection andserological INFORMATIONFlexHD PLIABLE is composed of an Acellular dermal tissue processing and packaging, this allograft was testedand showed no evidence of microbial growth, complying with therequirements of USP <71> Sterility not subjectallograft to additional sterilization of excess or unused tissue and all packaging that has beenin contact with the tissue in accordance with recognizedprocedures for discarding regulated medical waste FOR USES tandard accepted operative practices should be followed.

9 FlexHDPLIABLE is packaged in a sterilized foil pouch that is designed tobe passed directly into the sterile back the outer Tyvek Package and pass the inner foilpouch to the sterile FlexHD PLIABLE from the inner-foil pouchusing sterile gloves/forceps and immediately soak in asterile solution prior to the tissue has been removed from the inner pouch,discard the pouch and packaging solution outside of thesterile field and away from electrosurgical PLIABLE may be aseptically trimmed to fit thedimensions of the application tissue can beshaped with scissors or scalpel and rolled or folded todesired thickness.

10 At this point the FlexHD PLIABLE isready for application in the surgical the foil pouch containing FlexHD PLIABLEhas beenopened and exposed, the tissue shall be transplanted within 30minutes, otherwise, it can be maintained in a sterile saline bath andmust be implanted or discarded within 24 hours provided theallograft is maintained in an aseptic order to discern the dermal side from the epidermal side, notethat in most instances the epidermal side may have morepigmentation than the dermal side.