BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PRECLUDE DURA SUBSTITUTE

    MDR report key: 3143366 · Received May 24, 2013

    Report

    Report Number
    2017233-2013-00325
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    August 1, 1995
    Report Date
    May 13, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    GXQ
    PMA / PMN Number
    K953969
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: NAKAGAWA, S, ET AL POSTOPERATIVE INFECTION AFTER DURAPLASTY WITH EXPANDED POLYTETRAFLUOROETHYLENE SHEET, NEUROL MED CHIR (TOKYO), 2003 MARCH; 43: 120-124. CONCLUSIONS: A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED BECAUSE THE LOT #'S REMAIN UNK. THE DEVICES WERE OT RETURNED TO GORE, S NO ENGINEERING INVESTIGATIONS COULD BE PERFORMED.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED, "POSTOPERATIVE INFECTION AFTER DURAPLASTY WITH EXPANDED POLYTETRAFLUOROETHYLENE SHEET," IT INDICATES 2 PTS DEVELOPED AN INFECTION REQUIRING REINTERVENTION. THESE INFECTION DID NOT RESOLVE AFTER REMOVAL OF THE INFECTED BONE AND ANTIBIOTIC IRRIGATION. THESE PTS REQUIRED VASCULARIZED FREE RECTUS ABDOMINUS MUSCLE FLAP TRANSFER AFTER REMOVAL OF EPTFE SHEETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231560 GORE PRECLUDE DURA SUBSTITUTE GXQ/DURA SUBSTITUTE GXQ W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention