BEUDAMED
    FDA Adverse Event Summary report: N

    ORTHO WIRE

    MDR report key: 30851 · Received March 4, 1996

    Report

    Report Number
    MW4001087
    Date Received
    March 4, 1996
    Report Date
    February 13, 1996
    Manufacturer
    KIRSCHNER MEDICAL CORP.
    Product Code
    LRN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAS HAD A CHRONIC BONE INFECTION FROM WIRE AND PLATE. SHE IS TRYING TO OBTAIN AS MUCH INFORMATION AS POSSIBLE ON DEVICES. SHE IS CONCERNED THAT DEVICES WERE NOT APPROVED AND WERE IMPLANTED ANYWAY. THE WIRE BEGAN COMING OUT OF HER ARM AND IT WAS RECOMMENDED IT BE REMOVED. RPTR ALSO SAW A SURGEON WHO RECOMMENDED PLATES BE REMOVED. (ALSO SEE 4001088)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO WIRE SURGICAL WIRE LRN KIRSCHNER MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 *