BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE-IMAS PEDICLE SCOPE

    MDR report key: 2945269 · Received February 1, 2013

    Report

    Report Number
    2530088-2013-10007
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Report Date
    March 30, 2011
    Manufacturer
    SYNTHES (USA) BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING... THE SAMPLE WAS RECEIVED IN TWO PIECES. VISUAL INSPECTION NOTED A FRACTURE ON THE HANDLING RING DIRECTLY AT THE SITE WHERE THE HANDLING RING MATES WITH THE HANDLE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND DO NOT SHOW ANY MANUFACTURING NONCONFORMANCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LUMBAR FUSION AT L5-S1, WHILE THE IMAS PEDICLE SCOPE WAS INSIDE THE PT BEING TORQUED, THE HANDLE OF THE SCOPE BROKE WHERE THE HANDLE/SCOPE INTERFACED. NOTHING WAS LEFT IN THE PT AND THE PT WAS UNHARMED. THE PROCEDURE WAS COMPLETED WITHOUT ADDITIONAL TIME ADDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44502 HANDLE-IMAS PEDICLE SCOPE FZX SYNTHES (USA) BRANDYWINE 6341076

    Patients

    Seq Age Sex Outcome Treatment
    1