BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ CONCEPTS

    MDR report key: 3077237 · Received April 19, 2013

    Report

    Report Number
    MW5029888
    Event Type
    Injury
    Date Received
    April 19, 2013
    Date of Event
    March 1, 2011
    Report Date
    April 19, 2013
    Manufacturer
    TMJ CONCEPTS
    Product Code
    LZD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TMJ CONCEPTS DEVICE IMPLANTED IN (B)(6) 2011. WIRED SHUT FOR 10 WEEKS AND NEVER RECOVERED. LOST 35 LBS. VOMITING STARTED AFTER WIRES REMOVED WHICH LASTED A YR. SPECS OF FRESH BLOOD IN EAR FOR OVER 7 MONTHS. NOW SUFFERING FROM: PARALYSIS, NERVE DAMAGE, NUMBNESS IN LIP AREA, LOSS TASTE AND SMELL, CYSTS IN UTERINE LINING, KIDNEYS INFLAMED, NECK AND BACK ISSUES, OROMANDIBULAR TREMOR, STOMACH PROBLEMS, BALANCE AND DIZZINESS ISSUES, HEARING PROBLEMS, HEADACHES, MEMORY ISSUES, AND LEG AND EYE TWITCHING. PT HAD TO GIVE UP CAREER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170733 TMJ CONCEPTS TMJ CONCEPTS LZD TMJ CONCEPTS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| O| R