BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VHS VARIABLE ANGLE PLATE

    MDR report key: 232964 · Received July 16, 1999

    Report

    Report Number
    1825034-1999-00071
    Event Type
    Injury
    Date Received
    July 16, 1999
    Date of Event
    June 14, 1999
    Report Date
    July 16, 1999
    Manufacturer
    BIOMET, INC.
    Product Code
    HRS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING INSERTION OF A VARIABLE ANGLE PLATE IN 06/14/1999, THE LAG SCREW BENT AND WAS NOT ABLE TO BE PLACED IN THE SIDE PLATE. COMPONENT WAS REPLACED WITH A FIXED ANGLE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VHS VARIABLE ANGLE PLATE Implant FIXATION, TRAUMA, COMP. HRS BIOMET, INC. NA 552800

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention