BEUDAMED
    FDA Adverse Event Summary report: N

    TMJ CONCEPTS

    MDR report key: 3052853 · Received April 5, 2013

    Report

    Report Number
    MW5029703
    Date Received
    April 5, 2013
    Date of Event
    February 20, 2013
    Report Date
    April 5, 2013
    Manufacturer
    TMJ CONCEPTS
    Product Code
    LZD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT HAS BEEN HAVING SEVERE LEFT SIDE PAIN, HEADACHES, EARACHES, RATTLING NOISES, UNSTABLE BITE, SEVERE DECREASED ROM SINCE HER PROSTHESIS WAS IMPLANTED IN 2009. THE LEFT PROSTHESIS WAS EXPLANTED AND HER SURGEON NOTED THAT THE PROSTHESIS WAS ROTATED LATERALLY. IN ADDITION, THE CONDYLAR HEAD WAS JAMMED. THE SURGEON NOTED THE IMPLANT HAD POTENTIALLY ERODED INTO THE NATIVE MANDIBLE. IMMEDIATELY FOLLOWING REMOVAL OF LEFT JOINT PROSTHESIS, THE PT WAS ABLE TO OPEN FROM 12MM (PREOP) TO 45MM (POST OP). THE PT REPORTS ALL PAIN HAS SUBSIDED SINCE EXPLANT SURGERY AND ROM CONTINUES TO REMAIN AT 40 TO 45MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141748 TMJ CONCEPTS TMJ CONCEPTS LZD TMJ CONCEPTS

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention