BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ IMPLANTS

    MDR report key: 550470 · Received July 27, 2004

    Report

    Report Number
    MW1032816
    Event Type
    Injury
    Date Received
    July 27, 2004
    Report Date
    July 23, 2004
    Manufacturer
    TMJ IMPLANTS INC.
    Product Code
    LZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TMJ IMPLANTS, INC. WAS UNABLE TO INVESTIGATE THIS SPECIFIC COMPLAINT. IN ORDER TO COMPLETE AN INVESTIGATION, THE FOLLOWING INFO IS NECESSARY: SPECIFIC DEVICE INFO SUCH AS PRODUCT NUMBER OR LOT NUMBER CONFIRMING THAT THE MEDWATCH IS RELATED TO COMPANY'S DEVICE. IN ADDITION, THE TYPE OF DEVICE LISTED IS A "TMJ DISC IMPLANTS - BILATERALLY". TMJ IMPLANTS, INC. DO NOT SUPPLY DISC IMPLANTS, COMPANY DOES PROVIDE BILATERAL FOSSA-EMINENCE PROSTHESES.

    Description of Event or Problem · 1

    RECEIVED FIRST BILATERAL DISC REPLACEMENT IN 2002 FROM DR. THREE-FOUR MONTHS AFTER THE SURGERY THERE WAS SLIGHT IMPROVEMENT. A FEW MONTHS LATER THE JAW BEGAN TO SEIZE UP, WHILE POPPING IN AND OUT OF THE JOINT, WHICH NEVER OCCURRED BEFORE. VISITS TO THE ORAL SURGEON BECAME FEWER AND FEWER UNTIL FINALLY STOPPED GOING AS IT WAS POINTLESS. TWO YEARS AFTER IMPLANT SURGERY IN MORE PAIN THAN EVER EXPERIENCED IN LIFETIME. RECENTLY SAW DR WHO SAID THERE WAS NOTHING ELSE HE COULD DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TMJ IMPLANTS TMJ DISC IMPLANTS - BILATERAL LZD TMJ IMPLANTS INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Disability