BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIVA PORCINE DERMIS

    MDR report key: 9785538 · Received March 4, 2020

    Report

    Report Number
    3002924436-2020-00007
    Event Type
    Injury
    Date Received
    March 4, 2020
    Date of Event
    January 9, 2020
    Report Date
    March 4, 2020
    Manufacturer
    TUTOGEN MEDICAL GMBH
    Product Code
    FTM
    PMA / PMN Number
    K142070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MED WATCH SUBMITTED ONLY TO CORRECT LOT #, THE LOT # WAS INITALLY SUBMITTED AS PD17270001. THE CORRECT LOT# SHOULD HAVE BEEN PD17210001.

    Additional Manufacturer Narrative · 1

    THE GRAFT REMAINS IMPLANTED. THEREFORE, A COMPREHENSIVE RECORDS RE-REVIEW WAS CONDUCTED. THERE WERE NO DEPARTURES NOTED DURING RECORDS RE-REVIEW THAT WOULD NEGATIVELY IMPACT THE PROCESSING OF XENOGRAFTS MANUFACTURED FROM LOT PD17270001. MANUFACTURING RECORDS INDICATED THAT SERIAL ID (B)(4) MET ALL SPECIFICATIONS AND RELEASE CRITERIA PRIOR TO DISTRIBUTION. TO DATE, TMI HAS MANUFACTURED AND DISTRIBUTED A TOTAL OF 24 XENOGRAFTS FROM THE LOT WITHOUT RELATED COMPLAINTS. PORCINE DERMIS ALLOGRAFTS UNDERGO A VALIDATED STERILIZATION METHOD: TUTOPLAST®, WHICH INCLUDES TERMINAL STERILIZATION BY GAMMA IRRADIATION AFTER PACKAGING. TO DATE, OUR INVESTIGATION INDICATES THAT THE REPORTED COMPLICATIONS ARE MORE LIKELY ASSOCIATED WITH A SOURCE OR EVENT EXTRINSIC TO THE XENOGRAFT IMPLANT.

    Description of Event or Problem · 1

    RTI SURGICAL, INC. (RTI) AND TUTOGEN MEDICAL GMBH (TMI), A WHOLLY OWNED SUBSIDIARY OF RTI, RECEIVED A COMPLAINT AS PART OF HTE FORTIVA APPEAR TRIAL. THE REPORTED COMPLAINT INDICATED THAT A PATIENT UNDERWENT LEFT BREAST RECONSTRUCTION WITH IMPLANTATION OF A FORTIVA PORCINE DERMIS GRAFT AND A SILICONE IMPLANT ON (B)(6) 2019. THE PATIENT DEVELOPED NIPPLE NECROSIS TO LEFT BREAST REQUIRING SURGICAL DEBRIDEMENT ON (B)(6) 2020. SHE WAS TREATED WITH ANTIBIOTICS. THE AFFECTED AREA CONTINUED TO BREAK DOWN LEADING TO DEHISCENCE ON (B)(6) 2020. ON (B)(6) 2020, FURTHER NIPPLE DEBRIDEMENT WAS PERFORMED, AS WELL AS REMOVAL OF THE SILICONE IMPLANT AND CHANGED TO A TISSUE EXPANDER. THE FORTIVA XENOGRAFT REMAINS IMPLANTED. THE PATIENT WAS DISCHARGED ON (B)(6) 2020. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249323 FORTIVA PORCINE DERMIS PORCINE DERMIS GRAFT FTM TUTOGEN MEDICAL GMBH (1) PD17210001

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Other