BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ CONCEPTS

    MDR report key: 3202302 · Received June 25, 2013

    Report

    Report Number
    MW5030717
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 25, 2013
    Manufacturer
    TMJ CONCEPTS
    Product Code
    LZD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED BILATERAL TMJ IMPLANTS BY TMJ CONCEPTS IN 2001. AFTER SURGERY, EYE NERVES COULDN'T MOVE AND EYE LIDS WOULDN'T CLOSE. TO THIS DAY, PT CONTINUES TO HAVE EYE PROBLEMS. RIGHT EYE LID DOESN'T CLOSE ALL THE WAY. PT IS UNABLE TO CHEW FOOD AND INSTEAD MUST CUT UP FOOD. ESSENTIALLY ON A SOFT FOOD DIET. PT FEELS JOINTS ARE SHUTTING DOWN AS OPENING HAS SIGNIFICANTLY DECREASED. PT ALSO SUFFERS FROM A CONSTANT EAR ACHE, TINNITUS, TM JOINT PAIN, EYE PAIN AND SKULL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288573 TMJ CONCEPTS TMJ CONCEPTS TOTAL JOINT DEVICE LZD TMJ CONCEPTS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention| S