BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ CONCEPTS

    MDR report key: 2163569 · Received July 7, 2011

    Report

    Report Number
    MW5021313
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 28, 2009
    Report Date
    July 7, 2011
    Manufacturer
    TMJ SOLUTIONS
    Product Code
    LZD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECEIVED TMJ CONCEPTS DEVICE IN (B)(6) 2009. THIS WAS MY 7TH JAW SURGERY AND IT WAS THE WORST SURGERY I'VE EVER BEEN THROUGH. DURING THE 12 HOUR PROCEDURE, MY AIRWAY WAS CUT OFF. SINCE THE PROCEDURE, I'VE HAD TO GO THE E.R. THREE TIMES DUE TO THE INTENSE PAIN. MY ORAL SURGEON, DR. (B)(6), ALSO DID WORK ON MY NOSE AND SINUSES AND I NOW HAVE ALLERGIES AND MY EARS ARE CONSTANTLY STUFFED UP. I NEVER HAD ALLERGY ISSUES BEFORE THIS PROCEDURE. MY BITE IS NOW SO FAR OFF AND MY MOUTH NOW HAS A REALLY DEEP PALATE. MY LIPS AND FACE BURN, AND JAW IS NON-FUNCTIONAL. MY MEMORY IS SHOT AND I SUFFER FROM HEADACHES IN BACK OF HEAD/BASE OF SKULL AREA. SINCE THE PROCEDURE, I FEEL LIKE A MANIKIN, NOTHING FEELS NATURAL. IT'S ALL MECHANICAL. I'M TAKING MORE MEDICATION THAN EVER BEFORE FOR THE PAIN. EVERY TIME I POP A PILL I HATE IT! I'VE EXPRESSED MY CONCERNS TO DR. (B)(6) AND HAVE NOT RECEIVED ANY GOOD ANSWERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TMJ CONCEPTS TMJ CONCEPTS TMJ TOTAL JOINT LZD TMJ SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| O| R| S