BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIBLE HUMERAL NAIL

    MDR report key: 507364 · Received January 21, 2004

    Report

    Report Number
    2520274-2004-00003
    Event Type
    Injury
    Date Received
    January 21, 2004
    Date of Event
    January 8, 2004
    Report Date
    January 8, 2004
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON COMPLAINED THAT HE COULD NOT REMOVE THE FLEXIBLE HUMERAL NAIL FROM THE PT. THE PT'S FRACTURE HAD HEALED, BUT THE PT DEVELOPED BURSITIS AND EXPERIENCED PAIN. DURING THE PROCEDURE THE SURGEON HAD TO ENLARGE THE INCISION TO DIG AROUND THE IMPLANT AND REMOVE SOME BONE. THE ATTEMPTED REMOVAL RESULTED IN A FRACTURE IN THE PROXIMAL LATERAL CORTEX OF THE BONE. THE NAIL REMAINS IN THE PT AND THERE ARE NO FURTHER PLANS FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIBLE HUMERAL NAIL FLEXIBLE NAILS KWJ SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention