BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIVA

    MDR report key: 14115593 · Received April 14, 2022

    Report

    Report Number
    3002924436-2022-00005
    Event Type
    Injury
    Date Received
    April 14, 2022
    Date of Event
    December 13, 2021
    Report Date
    May 12, 2022
    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

    AT THIS TIME, IT IS UNKNOWN IF THE GRAFT REMAINS IMPLANTED. A COMPREHENSIVE RECORDS RE-REVIEW IS BEING CONDUCTED. ONCE THE RESULTS ARE AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    RTI GERMANY CONDUCTED A BATCH DOCUMENTATION REVIEW FOR SERIAL ID (B)(6) MANUFACTURED FROM LOT PD18440001. ONE DEPARTURE FROM STANDARD OPERATING PROCEDURES WAS NOTED DURING THE RECORDS RE-REVIEW THAT WOULD NOT NEGATIVELY IMPACT THE MANUFACTURING OF PORCINE DERMIS XENOGRAFTS FROM LOT PD18440001. SERIAL ID (B)(6) WAS MANUFACTURED TO THE SPECIFICATION DETAILED IN SP-61100 "04", ANNEX 1-6 "02". THE GRAFT MET ALL ACCEPTANCE / INSPECTION CRITERIA PRIOR TO DISTRIBUTION. TO DATE, RTI GERMANY HAS DISTRIBUTED 29 FORTIVA® TISSUE MATRIX 1MM GRAFTS FROM THE LOT PD18440001 WITHOUT RELATED COMPLAINTS. THE PATIENT DID NOT UNDERGO ANY ACTIVE INTERVENTION. SWELLING IS A COMMON SYMPTOM ASSOCIATED WITH LYMPHEDEMA. THE MOST COMMON TYPE OF LYMPHEDEMA IS PAINLESS AND MAY SLOWLY DEVELOP 18 TO 24 MONTHS OR MORE AFTER SURGERY. IT IS MORE PLAUSIBLE THAT THE PATIENT'S ADVERSE EVENT WAS ASSOCIATED WITH A SOURCE OR EVENT EXTRINSIC TO THE XENOGRAFT IMPLANT. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    ON 03/16/2022, RTI SURGICAL, INC. AND TUTOGEN MEDICAL (B)(4), A WHOLLY SUBSIDIARY OF RTI SURGICAL, RECEIVED A COMPLAINT AS PART OF THE FORTIVA APPEAR TRIAL. THE REPORTED COMPLAINT INDICATED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A LEFT BREAST RECONSTRUCTION POST-MASTECTOMY, REMOVAL OF THREE LYMPH NODES ON THE LEFT SIDE, AND IMPLANTATION OF A FORTIVA DERMAL GRAFT. A SILICONE IMPLANT AND TWO DRAINS WERE ALSO PLACED. ON (B)(6) 2021, THE PATIENT HAD DEVELOPED LYMPHOEDEMA ON THE LEFT SIDE. IT IS UNKNOWN IF THE ADVERSE EVENT IS ASSOCIATED TO THE GRAFT OR TO THE PROCEDURE. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1410665 FORTIVA PORCINE DERMIS FTM TUTOGEN MEDICAL, GMBH PD18440001

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Other