BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIVA

    MDR report key: 12782828 · Received November 9, 2021

    Report

    Report Number
    3002924436-2021-00033
    Event Type
    Injury
    Date Received
    November 9, 2021
    Date of Event
    May 19, 2021
    Report Date
    November 3, 2021
    Manufacturer
    TUTOGEN MEDICAL, GMBH
    Product Code
    FTM
    PMA / PMN Number
    K142070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE BATCH DOCUMENTATION INCLUDING THE ENDOTOXIN TEST, THE INDIVIDUAL DONOR PROTOCOL, THE IKZ PROTOCOL, THE RANDOM SAMPLE TEST AND THE STERILIZATION CERTIFICATE WERE REVIEWED. A DISCREPANCY WAS FOUND WHICH, HOWEVER, HAD NO EFFECT ON THE COMPLAINT GRAFT. ACCORDING TO THE DOCUMENTATION, THE PRODUCT WAS THEREFORE MANUFACTURED IN ACCORDANCE WITH THE SPECIFICATION. DURING THE TREND ANALYSIS, 12 COMPARABLE COMPLAINTS WITH 13 PRODUCTS WERE FOUND FOR THE SAME PRODUCT CODE. SINCE THIS IS NOT A SPONTANEOUS REPORT, BUT AN INCREASE IN FREQUENCY DUE TO THE CLINICAL STUDY, THERE IS NO TREND. BASED ON THE DATA RECEIVED AND THE INSPECTION OF THE BATCH DOCUMENTATION, THERE IS NO INDICATION OF THE UNSTERILITY OF THE AFFECTED PRODUCTS. BASED ON THE RESULTS OF THIS INVESTIGATION, IT IS MORE PLAUSIBLE THAT THE PATIENT'S ADVERSE REACTION WAS ASSOCIATED WITH A SOURCE OR EVENT EXTRINSIC TO THE XENGRAFT IMPLANT.

    Description of Event or Problem · 0

    RTI SURGICAL, INC (RTI) AND TUTOGEN MEDICAL (B)(4), A WHOLLY SUBSIDIARY OF RTI, RECEIVED A COMPLAINT ON 06/30/2021, AS PART OF THE FORTIVA APPEAR TRIAL. THE REPORTED COMPLAINT INDICATED THAT A PATIENT WAS IMPLANTED WITH A FORTIVA PORCINE DERMIS ON (B)(6) 2021 AND ON AN UNKNOWN DATE. ON (B)(6) 2021, THE PATIENT DEVELOPED SEROMAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1678605 FORTIVA PORCINE DERMIS, PRODUCT CODE FTM FTM TUTOGEN MEDICAL, GMBH PD18300001

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other