BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ CONCEPTS

    MDR report key: 548395 · Received September 27, 2004

    Report

    Report Number
    MW1033556
    Event Type
    Injury
    Date Received
    September 27, 2004
    Date of Event
    November 18, 2003
    Report Date
    September 27, 2004
    Manufacturer
    TMJ CONCEPTS
    Product Code
    LZD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN CONSTANT PAIN, MUCH WORSE THAN BEFORE SURGERY. REPORTER NEVER THOUGHT IT COULD GET THIS BAD. REPORTER'S BITE IS NOT STABLE AND IS CONSTANTLY CHANGING. JAW MUSCLES ARE NEVER AT REST. EXTREME FATIGUE, RESTING 20 HOURS A DAY. EXPERIENCING NUMBNESS IN FINGERS AND ARMS. REPORTER HAS NO APPETITE AND HAS LOST 30 LBS. SINCE SURGERY. ONLY ABLE TO EAT SOFT FOODS. UNABLE TO WORK. IF THIS DOESN'T GET BETTER REPORTER THINKING OF ENDING THEIR LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TMJ CONCEPTS TMJ TOTAL JAW JOINT REPLACEMENT DEVICE LZD TMJ CONCEPTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Disability