BEUDAMED
    FDA Adverse Event Injury Summary report: N

    95 DEGREE DCS PLATE

    MDR report key: 181072 · Received August 4, 1998

    Report

    Report Number
    8030965-1998-00007
    Event Type
    Injury
    Date Received
    August 4, 1998
    Date of Event
    February 29, 1996
    Report Date
    June 30, 1998
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    DCS PLATE WAS IMPLANTED ON MAY 12, 1995 FOR A SEVERELY COMMINUTED FRACTURE OF THE LEFT FEMUR (BONE FRACTURED IN 17 PIECES). X-RAY TAKEN ON FEBRUARY 27, 1996 SHOWED A NON-UNION OF THE LEFT HIP AND THE PLATE WAS BROKEN. THE PLATE WAS REMOVED ON FEBRUARY 29, 1996.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 95 DEGREE DCS PLATE Implant DHS/DCS PLATES KWQ SYNTHES (USA) NA 1177

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention SCREWS (05/12/1995 TO 02/29/1996).