BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANGEA

    MDR report key: 745036 · Received July 19, 2006

    Report

    Report Number
    745036
    Event Type
    Malfunction
    Date Received
    July 19, 2006
    Date of Event
    July 6, 2006
    Report Date
    July 19, 2006
    Manufacturer
    SYNTHES USA, INC.
    Product Code
    HXC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    EARLY FEEDBACK FROM THE MANUFACTURER INDICATES THAT THERE WAS A FAILURE OF THE TORQUE WRENCH AND ONE ADDITIONAL INSTRUMENT VERSUS THE SPINAL IMPLANTS. THE TORQUE WRENCH WAS DAMAGING THE LOCKING CAPS AND RESULTED IN THE DEVICE FAILURE.PARTIAL SURGERY WAS COMPLETED AND PATIENT WILL BE BROUGHT BACK FOR SECONDARY SURGERY IN A WEEK'S TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PANGEA WRENCH, SURGICAL TORQUE HXC SYNTHES USA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *