BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOMET

    MDR report key: 970425 · Received December 20, 2007

    Report

    Report Number
    MW5004799
    Event Type
    Other
    Date Received
    December 20, 2007
    Date of Event
    January 23, 2006
    Report Date
    February 21, 2006
    Manufacturer
    BIOMET OF MID OHIO
    Product Code
    LXH
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS INCIDENT INVOLVED A CONSIGNMENT INSTRUMENT TRIAL NECK/HEAD (JOINT) DEVICE CAME APART AFTER PLACED IN JOINT. NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET TRIAL NECK/HEAD LXH BIOMET OF MID OHIO

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR