BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 MM TI CANCELLOUS LOCKING SCREW

    MDR report key: 560983 · Received May 6, 2004

    Report

    Report Number
    2530088-2004-00005
    Event Type
    Malfunction
    Date Received
    May 6, 2004
    Date of Event
    April 8, 2004
    Report Date
    April 8, 2004
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A LOCKING SCREW, IMPLANTED AT THE END OF JANUARY/FIRST PART OF 02/2004 WAS NOTED TO BE BACKING OUT ON A POST-OPERATIVE X-RAY. PT APPEARS TO BE FUSING AND THERE ARE NO PLANS FOR A RE-OPERATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.5 MM TI CANCELLOUS LOCKING SCREW LOCKING SCREWS HWC SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO PLATE