BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHATEC MOD.HIP.SCREW

    MDR report key: 165143 · Received April 27, 1998

    Report

    Report Number
    2027467-1998-00001
    Event Type
    Injury
    Date Received
    April 27, 1998
    Date of Event
    August 19, 1995
    Report Date
    April 27, 1998
    Manufacturer
    ALPHATEC MFG., INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ON APRIL 25, 1995, AFTER SUFFERING A FALL AND INJURING HIS RIGHT HIP, THE PT WAS SEEN IN THE EMERGENCY ROOM. ORTHOPEDIC CONSULTATION WITH DR. WAS REQUESTED. ON 4/26/95 DR. REDUCED A DISPLACED SPIRAL SUBTROCHANTERIC FRACTURE WITH A COMPRESSION SCREW AND 130 DEGREE SIDE PLATE WITH EIGHT HOLES. FIVE WEEKS POST OP, THE PT REPORTED NO PAIN AND WAS 50% WEIGHT BEARING DUE TO PROLONGED HEALING. THREE MONTHS AND THREE WEEKS, POST OP, THE PT WAS RE-EXAMINED AFTER FEELING A POP IN HIS RIGHT THIGH. THE X-RAYS SHOWED A FRACTURED SIDE PLATE WITH SIDE SCREWS BACKING OUT. THE DEVICE WAS REMOVED APPROXIMATELY ONE WEEK LATER AND REPLACED WITH AN IM ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHATEC MOD.HIP.SCREW Implant HIP TRAUMA IMPLANT HWC ALPHATEC MFG., INC. NA M2712-2, M2848-4

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R