BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ CONCEPTS

    MDR report key: 3088873 · Received April 26, 2013

    Report

    Report Number
    MW5030002
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 26, 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

    PT HAD TMJ CONCEPTS INSTALLED IN 2009. PT RECENTLY LEARNED FROM THE IMPLANTING SURGEON THAT HE MIS-MEASURED HER IMPLANT AND IMPLANTED IT ANYWAY. THE IMPLANT SHE RECEIVED WAS TOO LARGE FOR HER, SO HE USED BONE CEMENT TO MAKE IT FIT. PT HAS NOW LEARNED THE BONE CEMENT IS PUSHING AGAINST THE CEREBRAL ARTERIES WHICH IS PUSHING AGAINST HER TRIGEMINAL NERVE CAUSING A LOT OF PAIN. SINCE THEN PT HAS SEEN APPROXIMATELY 8 ORAL SURGEONS AND 7 INFECTIOUS DISEASE SPECIALISTS FOR HELP. PT IS SUFFERING FROM CONSTANT BURNING IN GUM AREA, A LARGE AMOUNT OF MUCUS DRAINAGE FROM NOSE, HEARING LOSS, FACIAL PARALYSIS, AND JAW GETS STUCK AND MUST BE PHYSICALLY MANIPULATED TO FREE IT UP. PT UNABLE TO WORK AND HAS A CERTIFIED NURSING ASSISTANT TO HELP HER. PT WILL HAVE TO HAVE SURGERY IN THE NEAR FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181492 TMJ CONCEPTS TMJ CONCEPTS LZD TMJ CONCEPTS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R| S