BEUDAMED
    FDA Adverse Event Injury Summary report: N

    13MM UNIVERSAL FEMORAL NAIL 400MM

    MDR report key: 1933018 · Received December 14, 2010

    Report

    Report Number
    2520274-2010-00243
    Event Type
    Injury
    Date Received
    December 14, 2010
    Report Date
    November 17, 2010
    Manufacturer
    SYNTHES (USA)
    Product Code
    JDS
    PMA / PMN Number
    K914371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. MANUFACTURE SITE AND MANUFACTURE DATE CANNOT BE DETERMINED WITHOUT A LOT NUMBER. INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    ATTORNEY ADVISED THE PT WAS IMPLANTED WITH A 13MM UNIVERSAL FEMORAL NAIL 400MM ON AN UNK DATE. POST OPERATIVE THE NAIL 'FAILED' AND WAS REMOVED ON AN UNK DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 13MM UNIVERSAL FEMORAL NAIL 400MM UNIVERSAL FEMORAL NAIL JDS SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention SCREWS