BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VHS VARIABLE ANGLE PLATE

    MDR report key: 303624 · Received November 3, 2000

    Report

    Report Number
    1825034-2000-00077
    Event Type
    Injury
    Date Received
    November 3, 2000
    Date of Event
    September 28, 2000
    Report Date
    November 2, 2000
    Manufacturer
    BIOMET, INC.
    Product Code
    HRS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE IMPLANTED IN 1999. SUBSEQUENT RADIOGRAPHS SHOWED NON-UNION OF FRACTURE AND ONE FRACTURED SCREW. SURGERY PERFORMED 12 WEEKS LATER, NOTED THAT ALL FOUR PLATE SCREWS HAD FRACTURED. HARDWARE WAS REMOVED AND REPLACED WITH BIPOLAR PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VHS VARIABLE ANGLE PLATE FIXATION, TRAUMA, COMP. HRS BIOMET, INC. NA 897680

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R