BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ CONCEPTS

    MDR report key: 2410427 · Received January 5, 2012

    Report

    Report Number
    MW5023748
    Event Type
    Injury
    Date Received
    January 5, 2012
    Date of Event
    January 5, 2012
    Report Date
    January 5, 2012
    Manufacturer
    TMJ SOLUTIONS
    Product Code
    LZD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD TMJ CONCEPTS BILATERAL TMJ IMPLANT DEVICES IMPLANTED IN (B)(6) 2010 BY DR. (B)(6). THIS WAS MY FIRST SET OF JAW IMPLANTS. I'M MUCH WORSE OFF NOW THAN BEFORE SURGERY. I HAVE DEVELOPED AN ALLERGIC REACTION TO THE PROSTHESIS AND NEED TO HAVE FURTHER ALLERGY TESTING DONE. I HAVE ALSO DEVELOPED SEVERE ALLERGIC REACTIONS TO MEDICATIONS. SINCE THE SURGERY I'VE LOST (B)(6) AND HAVE TROUBLE MAINTAINING MY WEIGHT. IN TOTAL, I'VE LOST (B)(6). I CAN'T CHEW AND MY DESIRE TO EAT IS GONE. I HAVE DEVELOPED A LISP. TALKING HURTS AND MY TEETH CAUSE ME EXTREME PAIN WHEN THEY TOUCH ONE ANOTHER. I WEAR A RETAINER TO PREVENT MY TEETH FROM HITTING. I AM ONLY ABLE TO GET ONE FINGER IN MY MOUTH AND AM UNABLE TO MOVE MY JAW FROM SIDE-TO-SIDE. MY BOTTOM LIP IS NUMB AND THE TOP LIP IS SWOLLEN AND TINGLES. DR. (B)(6) ALSO DID SURGERY ON MY NOSE WHICH CAUSED A LOT OF SCAR TISSUE AND LOTS OF PAIN. I'VE LOST MY HEARING SINCE THE SURGERY AND HAVE FLUID THAT WILL NOT DRAIN OUT CAUSING A LOT OF EAR PRESSURE. I SUFFER FROM CHRONIC SINUS INFECTIONS. IT HAS ALSO AFFECTED THE TEAR DUCTS IN MY RIGHT EYE. THE SURGERY HAS CHANGED THE WAY I LOOK: MY NOSE, CHEEKS AND FACE ARE DIFFERENT AND I DON'T RECOGNIZE MYSELF. I HAVE TROUBLE CONCENTRATING AND I TEND TO FORGET THINGS. ALL OF THIS HAS GREATLY AFFECTED MY QUALITY OF LIFE AND I STRUGGLE TO BE ABLE TO PERFORM MY JOB. I CONTACTED THE MANUFACTURER ABOUT MY CONCERNS AND I WAS TOLD DR. (B)(6) HAD NOT INFORMED THEM OF MY PROBLEMS. TMJ CONCEPTS DIDN'T HAVE MUCH TO SAY EITHER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening| O| R