BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ CONCEPTS TMJ IMPLANT

    MDR report key: 4949747 · Received July 23, 2015

    Report

    Report Number
    MW5044872
    Event Type
    Injury
    Date Received
    July 23, 2015
    Report Date
    July 23, 2015
    Manufacturer
    TMJ SOLUTIONS, INC.
    Product Code
    LZD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I HAVE TMJ CONCEPTS TOTAL JOINT IMPLANT DEVICE. I AM CURRENTLY SUFFERING FROM THE FOLLOWING ISSUES: SEVERE ALLERGIC TO NICKEL, JAW IS STARTING TO FREEZE SHUT, ALWAYS FEEL TIRED LIKE I HAVE A BAD FLU, AND A BURNING FEELING IN MY HEAD AND NUMBNESS IN MY FEET AND HANDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478522 TMJ CONCEPTS TMJ IMPLANT TMJ CONCEPTS TMJ IMPLANT LZD TMJ SOLUTIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability