BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ CONCEPTS

    MDR report key: 2500129 · Received March 16, 2012

    Report

    Report Number
    MW5024680
    Event Type
    Injury
    Date Received
    March 16, 2012
    Date of Event
    December 1, 2011
    Report Date
    March 16, 2012
    Manufacturer
    TMJ SOLUTIONS
    Product Code
    LZD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(6) 2010, PT RECEIVED TMJ CONCEPTS DEVICE ON RIGHT SIDE DUE TO ARTHRITIS IN THE JOINT. POST SURGERY, PT HAD 50% OPENING AND THE PAIN SUBSIDED, HOWEVER, PT'S BITE FELT OFF. PT CONTINUED TO INFORM ORAL SURGEON OF THE BITE ISSUE AND WAS ADVISED BY TO HAVE DENTAL WORK DONE. (B)(6) 2011, PT UNDERWENT RESTORATIVE DENTAL WORK, 4 NEW CROWN, AND 3 INFECTED TEETH WERE EXTRACTED. DENTAL WORK WAS COMPLETED IN (B)(6) 2011 AND AT THIS PONT THE PT COULD NO LONGER OPEN HER JAW ON THE RIGHT SIDE. EATING, DRINKING, SLEEPING AND TALKING IS LIKE TORTURE. PT'S BITE HAS COLLAPSED, IS UNABLE TO CLOSE MOUTH AND TEETH ARE HANGING OUT. PT DISCUSSED CONCERNS WITH ORAL SURGEON WHO SAID THE JOINT IS FINE AND THE PROBLEM IS A DENTAL ISSUE. PT SAW DENTIST WHO SAID IT'S NOT A DENTAL MATTER AND THAT THE RIGHT JAW IS OUT OF ALIGNMENT AND SHE NEEDS SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R