BEUDAMED
    FDA Adverse Event Other Summary report: N

    TOTAL TMJ IMPLANTS

    MDR report key: 1670607 · Received April 26, 2010

    Report

    Report Number
    MW5015718
    Event Type
    Other
    Date Received
    April 26, 2010
    Date of Event
    March 31, 2010
    Report Date
    April 26, 2010
    Manufacturer
    TMJ IMPLANTS, INC.
    Product Code
    LZD
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT WHO HAD RECEIVED TOTAL ALLOPLASTIC TMJ RECONSTRUCTIVE SURGERY OVER 10 YEARS EARLIER WAS IN A SERIOUS MVA IN WHICH CRANIO-MANDIBULAR STRUCTURES WERE TRAUMATIZED, NOW HAS POST TRAUMATIC TRISMUS AND JAW PAIN. SHE NEEDS TO BE EVALUATED BY HER SURGEON AND IMAGING ACCOMPLISHED TO DETERMINE DEGREE OF INJURY TO STRUCTURES AND IMPLANTS. THE DEVICES, APPARENTLY FUNCTIONED WELL UNTIL THE MVA AND WERE NOT THE CAUSE OF ANY PAIN OR DYSFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL TMJ IMPLANTS CHRISTENSEN TOTAL TMJ IMPLANTS LZD TMJ IMPLANTS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1