BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIVA PORCINE DERMIS

    MDR report key: 4861463 · Received June 19, 2015

    Report

    Report Number
    3002719998-2015-00013
    Event Type
    Injury
    Date Received
    June 19, 2015
    Date of Event
    December 30, 2014
    Report Date
    June 19, 2015
    Manufacturer
    TUTOGEN MEDICAL GMBH
    Product Code
    FTM
    PMA / PMN Number
    K081538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: GRAFT WAS NOT RETURNED TO RTI FOR EVAL, THEREFORE A RE-REVIEW WAS PERFORMED OF THE MFG RECORDS, STERILIZATION RUN REPORTS, ENVIRONMENTAL MONITORING RESULTS, QUALITY CONTROL / ASSURANCE REVIEWS AND RELEASE, AND THE COMPLAINT DATABASE FOR RELATED COMPLAINTS ASSOCIATED WITH THE LOT. RESULTS: NO DEVIATIONS WERE NOTED DURING THE RECORDS RE-REVIEW FOR LOT# MP131501 THAT WOULD NEGATIVELY IMPACT THE IMPLANT. THE GRAFT UNDERWENT A VALIDATED STERILIZATION; TUTOPLAST WHICH INCLUDES TERMINAL STERILIZATION BY GAMMA IRRADIATION AFTER PACKAGING. ENVIRONMENTAL DATA AND RECORDS GENERATED DURING AND AROUND THE TIME OF PROCESSING FOR LOT # MP131501 WERE ACCEPTABLE. TO DATE, RTI HAS DISTRIBUTED (B)(4)FROM THE LOT WITHOUT RELATED COMPLAINTS. CONCLUSION GIVEN THAT THE IMPLANT ID (B)(4) WAS MANUFACTURED TO SPEC PRIOR TO DISTRIBUTION, THERE ARE NO RELATED COMPLAINTS ASSOCIATED WITH IMPLANTS DISTRIBUTED FROM THIS LOT, AND PT'S PRE-EXISTING CONDITIONS, IT IS MORE PLAUSIBLE THAT THE PT'S OUTCOME AND COMPLICATIONS WERE ASSOCIATED WITH A SOURCE OR EVENT EXTRINSIC TO THE XENOGRAFT IMPLANT.

    Description of Event or Problem · 1

    RTI SURGICAL, INC (RTI) AND TUTOGEN MEDICAL (B)(4), A WHOLLY OWNED SUBSIDIARY OF RTI RECEIVED A COMPLAINT ON (B)(6) 2014 REPORTING THAT A PT UNDERWENT ABDOMINAL HERNIA REPAIR WITH IMPLANTATION OF FORTIVA IMPLANT ON (B)(6) 2014. APPROX 7 MONTHS LATER, ON (B)(6) 2014, THE PT UNDERWENT AN EXPLORATORY PROCEDURE DUE TO UNEXPLAINED ABDOMINAL PAIN, WHERE IT WAS NOTED THAT THE IMPLANT HAD DISINTEGRATED. HOWEVER, IT WAS EXPLANTED. MEDICAL RECORDS WERE REQUESTED ON SEVERAL OCCASIONS. COPIES OF RECORDS WERE RECEIVED ON (B)(6) 2015. THE PT IS A (B)(6) MORBIDLY OBESE MALE WHO UNDERWENT ABDOMINAL HERNIA REPAIR UTILIZING FORTIVA PORCINE DERMIS ON (B)(6) 2014. HE PRESENTED TO THE SURGEON'S OFFICE ON (B)(6) 2014 COMPLAINING OF SHARP ABDOMINAL PAIN AND BULGING. AN ABDOMINAL CT SCAN REVEALED THE IMPLANT WAS INTACT, BECAME LAX AND HAD BEGUN TO BULGE WITHOUT EVIDENCE OF INCARCERATION. ON (B)(6) 2014, HE UNDERWENT AN ABDOMINAL WALL RECONSTRUCTION FOR RECURRENT INCARCERATED INCISIONAL HERNIA. IT WAS NOTED THAT THE CENTRAL PORTION OF THE HERNIATION HAD NO BIOLOGIC MESH; THE FORTIVA WAS EXPLANTED AND SUBMITTED FOR PATHOLOGY. THE PT HAD A XENOGRAFT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400561 FORTIVA PORCINE DERMIS PORCINE DERMAL TISSUE FTM TUTOGEN MEDICAL GMBH MP131501

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention