BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VHS VARIABLE ANGLE PLATE

    MDR report key: 225531 · Received May 27, 1999

    Report

    Report Number
    1825034-1999-00057
    Event Type
    Injury
    Date Received
    May 27, 1999
    Date of Event
    February 25, 1999
    Report Date
    May 26, 1999
    Manufacturer
    BIOMET, INC.
    Product Code
    HRS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ANGLE PLATE WAS IMPLANTED 98. REMOVAL AND REPLACEMENT OF THE DEVICE OCCURRED ON 99, DUE TO THE COLLAPSE OF THE PLATE COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VHS VARIABLE ANGLE PLATE Implant FIXATION, TRAUMA, COMP. HRS BIOMET, INC. NA 709590

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention