BEUDAMED
    FDA Adverse Event Other Summary report: N

    DURAGEN XS DURAL RENERATION MATRIX 3X3 GRAFT

    MDR report key: 2605021 · Received March 6, 2009

    Report

    Report Number
    1121308-2009-00044
    Event Type
    Other
    Date Received
    March 6, 2009
    Date of Event
    January 23, 2009
    Report Date
    March 6, 2009
    Manufacturer
    INTEGRA LIFESCIENCES
    Product Code
    GXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE PT DEVELOPED AN INFECTION FOLLOWING A LAMINECTOMY FOR RESECTION OF DURAL SINUS TRACT AND INTRAMEDULLARY LIPOMA RESECTION WITH A TETHERED CORD RELEASED. SHE IS NOW AN OUTPATIENT ON ANTIBIOTIC THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAGEN XS DURAL RENERATION MATRIX 3X3 GRAFT NA GXQ INTEGRA LIFESCIENCES 1073337

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR SURGICAL| TISSEEL| BACITRACIN 50,000 UNITS IN 1000ML NORMAL SALINE| AS ANTIBIOTIC IRRIGATION INTO THE SURGICAL SITE| SURGIFOAM