BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ CONCEPTS

    MDR report key: 3015725 · Received March 14, 2013

    Report

    Report Number
    MW5029422
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 14, 2013
    Manufacturer
    TMJ CONCEPTS
    Product Code
    LZD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TMJ CONCEPTS DEVICE IMPLANTED BILATERALLY IN 2010. I HAVE HAD MANY COMPLICATIONS SINCE THIS SURGERY. IN (B)(6) 2013 I UNDERWENT SURGERY ON THE LEFT PROSTHESIS WHICH WAS ROTATED AND THE SCREWS WERE BENT. I WILL BE GETTING A NEW PROSTHESIS TO REPLACE THE BROKEN SIDE. THE RIGHT PROSTHESIS IS FUNCTIONING FINE SO FAR. IN ADDITION TO THE LEFT JOINT PROBLEM I AM BEGINNING TO HAVE ALL KINDS OF IMMUNE ISSUES INCLUDING SENSITIVITY ISSUES. I ALSO HAVE INCREASED MEMORY LOSS, ACID REFLUX DISEASE, CANDIDA INFECTION THROUGH THE BODY AND NOW SJOGREN'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108259 TMJ CONCEPTS TMJ CONCEPTS LZD TMJ CONCEPTS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O| R