BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ CONCEPTS

    MDR report key: 935325 · Received October 25, 2007

    Report

    Report Number
    MW5004203
    Event Type
    Injury
    Date Received
    October 25, 2007
    Date of Event
    March 9, 2005
    Report Date
    October 25, 2007
    Manufacturer
    TMJ CONCEPTS
    Product Code
    LZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE SURGEON AT THE HOSPITAL. DID A TOTAL JOINT REPLACEMENT ON MY RIGHT TEMPOROMANDIBULAR JOINT AND INSTALLED A TMJ CONCEPTS REPLACEMENT JOINT. THIS PROSTHETIC JOINT HAS CAUSED CHRONIC PAIN AND INABILITY TO TALK, CARRY A CONVERSATION, LAUGH, OR CHEW. IT IS TOTALLY OBSOLETE, AND HAS MADE MY LIFE A PURE HELL OF CHRONIC PAIN, THAT HAS LED TO FIBROMYALGIA AND MISALIGNMENT OF MY TEETH, IT DOESN'T EVEN MOVE. THE PROSTHESIS WAS MANUFACTURED BY TMJ CONCEPTS. THE SURGEON WHO PERFORMED THE JOINT REPLACEMENT SAYS THERE IS NOTHING MORE HE CAN DO FOR ME, AND I CAN'T EVEN FIND ANOTHER DR. WHO CAN HELP RELIEVE THE EXCRUCIATING CHRONIC PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TMJ CONCEPTS TMJ CONCEPTS STEEL JOINT REPLACEMENT FOR LZD TMJ CONCEPTS TMJ CONCEPTS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention DAILY DRUG USE FOR PAIN| PHYSICAL THERAPY| TEMPORMANDIBULAR JOINT.| TMJ CONCEPTS TOTAL JOINT REPLACEMENT FOR| ON-GOING SINCE SURGERY AND BITE SPLINT THERAPY