BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ IMPLANT'S INC. FOSSA EMINENCE

    MDR report key: 426505 · Received November 5, 2002

    Report

    Report Number
    MW1026649
    Event Type
    Injury
    Date Received
    November 5, 2002
    Report Date
    November 5, 2002
    Manufacturer
    TMJ IMPLANTS, INC.
    Product Code
    LZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO FROM MFR 12-13-02: TMJ IMPLANTS, INC HAS NO INFO FROM A MEDICAL PROFESSIONAL TO INDICATE THAT AN ADVERSE EVENT HAS OCCURRED. NO MDR WILL BE FILED IN RESPONSE TO THE ABOVE REFERENCED DOCUMENT.

    Description of Event or Problem · 1

    RECEIVED A CHRISTENSEN FOSSA BILATERALLY. ONE YEAR LATER PT BEGAN HAVING GRAND MAL SEIZURES FOR THE FIRST TIME. PT NOW HAS PERSISTENT MIGRAINE AND FACIAL SWELLING WHICH HAS CLOSED OFF THE EAR CANAL AND CAUSES BLACK EYES. SCREWS FROM FOSSA HAVE LOOSENED AND HAVE PENETRATED THROUGH TO THE ZYGOMATIC ARCH. PT IS IN NEED OF BOTH FOSSAS BEING REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TMJ IMPLANT'S INC. FOSSA EMINENCE TITANIUM FOSSA BILATERALLY LZD TMJ IMPLANTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention| S