BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VHS VARIABLE ANGLE PLATE

    MDR report key: 280634 · Received June 2, 2000

    Report

    Report Number
    1825034-2000-00032
    Event Type
    Injury
    Date Received
    June 2, 2000
    Date of Event
    April 11, 2000
    Report Date
    June 1, 2000
    Manufacturer
    BIOMET, INC.
    Product Code
    HRS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT INSERTION OF VHS PLATE AND LAG SCREW IN 1999. PT FELL AND RADIOLOGRAPHS INDICATED A PORTION OF THE PLATE AT THE JUNCTION OF THE LAG SCREW HOLE FRACTURE. INITIAL FRACTURE SITE APPEARED HEALED AND HARDWARE WAS REMOVED IN 2000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VHS VARIABLE ANGLE PLATE FIXATION, TRAUMA, COMP. HRS BIOMET, INC. NA 132190

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R