BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHARLOTTE SNAP-OFF SCREW

    MDR report key: 1013954 · Received March 12, 2008

    Report

    Report Number
    1043534-2008-00039
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 12, 2008
    Report Date
    March 1, 2008
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HWC
    PMA / PMN Number
    K043583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETED. TRENDS WILL BE EVALUATED. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, A MEDWATCH 3500A HAS NOT BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    ALLEGED SCREW BROKE BELOW THE HEAD WHILE SURGEON WAS TIGHTENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHARLOTTE SNAP-OFF SCREW HWC WRIGHT MEDICAL TECHNOLOGY, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other