BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METAL TMJ IMPLANT

    MDR report key: 35918 · Received August 28, 1996

    Report

    Report Number
    MW1009811
    Event Type
    Injury
    Date Received
    August 28, 1996
    Date of Event
    January 12, 1994
    Report Date
    June 23, 1996
    Manufacturer
    VITEK, INC.
    Product Code
    LZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS METAL IMPLANT WAS PUT IN RT TMJ ON 1/12/94. SINCE RPTR HAS HAD SEVERE CHRONIC PAIN, NUMBNESS, INFECTION, AND IT POPS AND CRACKS AT TIMES, RPTR FINDS IT IS IIMPOSSIBLE TO CHEW OR OPEN HER MOUTH VERY FAR. RPTR WAS INFORMED THAT THE TISSUE AND BONE HAS DETERIORATED AND POSSIBLE THE DEVICE HAS BROKEN. RPTR HAS CHRONIC PAIN THAT RADIATES UP THROUGH THIS RT SIDE OF HER HEAD AND DOWN THROUGH HER NECK AND SHOULDERS. RPTR HAS TO GO TO THE HOSP EVERY COUPLE OF MONTHS TO HAVE IT MANUALLY MANIPULATED AND SHE IS ON STADOL, BECAUSE THE PAIN IS UNBEARABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 METAL TMJ IMPLANT Implant TMJ IMPLANT LZD VITEK, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention| S 2-94-9-94