BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 1810127 · Received August 17, 2010

    Report

    Report Number
    2520274-2010-00153
    Event Type
    Injury
    Date Received
    August 17, 2010
    Report Date
    July 19, 2010
    Manufacturer
    SYNTHES (USA)
    Product Code
    NKB
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PART OR LOT NUMBER PROVIDED. CANNOT BE DETERMINED WITHOUT PART AND LOT NUMBER. NO CONCLUSION CAN BE DRAWN, INVESTIGATION NOT COMPLETED. DEVICE HISTORY RECORD REVIEW CANNOT BE REQUESTED WITHOUT PART AND LOT NUMBER OF DEVICE.

    Description of Event or Problem · 1

    PT IS A FIT YOUNG MALE WITH AN AO 31C3 FRACTURE. PROXIMAL FEMORAL PLATE WAS INSERTED WITH CONICAL SCREWS USED FOR COMPRESSION OF FRAGMENTS. PT WAS UP OUT OF BED MOBILIZING THE FOLLOWING DAY. PLATE BENT AT THE SECOND SCREW HOLE INTO AN UNACCEPTABLE POSITION AND WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI PROXIMAL FEMUR PLATE NKB SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention CONICAL SCREWS