BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURA GEN

    MDR report key: 1942120 · Received December 23, 2010

    Report

    Report Number
    MW5018714
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    December 9, 2010
    Report Date
    December 23, 2010
    Manufacturer
    INTEGRA LIFESCIENCES CORP
    Product Code
    GXQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS PERFORMING A POSTERIOR DECOMPRESSION OF FORAMEN MAGNUM WITH C1 LAMINECTOMY AND DURAPLASTY AND WAS TRYING TO UTILIZE DURAGEN DURAL REGENERATION MATRIX AND IT SEPARATED AT THE POINT OF CONTACT. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: DURAL REPAIR. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURA GEN DURAL REGENERATION MATRIX GXQ INTEGRA LIFESCIENCES CORP 1102683

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR