BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NERVE HOOK CUSHION BULL TIP

    MDR report key: 1193623 · Received October 8, 2008

    Report

    Report Number
    MW5008587
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    September 29, 2008
    Report Date
    October 8, 2008
    Manufacturer
    SPECIALTY SURGICAL INSTRUMENTATION
    Product Code
    GDG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE BACK SURGERY, THE SURGEON WAS USING THE NERVE HOOK TO MOVE THE NERVE AND THE TIP BROKE OFF. HE WAS UNABLE TO VISUALIZE IT, FLUOROSCOPY DONE INTRAOPERATIVELY SHOWED THE TIP INSIDE THE DISC. ATTEMPTS TO REMOVE IT WERE UNSUCCESSFUL. THE TIP REMAINS IN THE DISC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NERVE HOOK CUSHION BULL TIP NERVE HOOK GDG SPECIALTY SURGICAL INSTRUMENTATION

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other