BEUDAMED
    FDA Adverse Event Other Summary report: N

    TMJ FOSSA-EMINENCE PROSTHESIS

    MDR report key: 394192 · Received May 10, 2002

    Report

    Report Number
    1721760-2002-00001
    Event Type
    Other
    Date Received
    May 10, 2002
    Date of Event
    January 30, 2002
    Report Date
    May 9, 2002
    Manufacturer
    TMJ IMPLANTS, INC.
    Product Code
    LZD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER TEN YEARS OF CONTINUAL WEAR, THE PATIENT HAD BI-LATERAL TOTAL SURGERY TO REPLACE THE EXISTING TEMPORMANDIBULAR JOINT PROSTHESES SYSTEM. DURING SURGERY, IT WAS NOTED THAT THE LEFT FOSSA-EMINENCE DEVICE WAS FRACTURED ALONG THE SCREW LINE. ALL OF THE EXISTING TMJ IMPLANTS, INC. DEVICES WERE REMOVED AND REPLACED BY TMJ IMPLANTS, INC. DEVICES, WHICH WERE SPECIFICALLY MADE ACCORDING TO THE PATIENT'S ANATOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TMJ FOSSA-EMINENCE PROSTHESIS TEMPOROMANDIBULAR JOINT PROSTHESIS SYSTEM LZD TMJ IMPLANTS, INC. FEL-24 M

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other