BEUDAMED
    FDA Adverse Event Death Summary report: N

    CHRISTENSEN TMJ IMPLANT

    MDR report key: 676278 · Received November 8, 2005

    Report

    Report Number
    MW4004090
    Event Type
    Death
    Date Received
    November 8, 2005
    Date of Event
    January 1, 2003
    Manufacturer
    TMJ IMPLANTS INC
    Product Code
    LZD
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR STATES SHE HAS A TOTAL JOINT REPLACEMENT AND REPOSITION OF BOTH JAWS. RPTR CUSTOMER CHRISTENSEN TMJ IMPLANTS MADE FOR THE RIGHT AND LEFT SIDE. THE CUSTOM MADE UNIT FOR THE RIGHT SIDE DID NOT FIT SO A STOCK IMPLANT WAS IMPLANTED. THE RIGHT SIDE IMPLANT SCREWS BACKOUT OUT. RIGHT UNIT HAS SINCE BEEN REMOVED. RPTR HAD AN EPISODE SIMILAR TO BELL'S PALSY AFTER THE FIRST SURGERY. SHE HAD A CHRONIC INFECTION DURING THE FIRST YEAR AFTER HER INITIAL SURGERY. RPTR HAS HAD CHRONIC PAIN SINCE THE ORIGINAL SURGERY. COMPLAINTANT CAN ONLY CLOSE RIGHT EYE ABOUT HALF WAY. THE LEFT IMPLANT SCREWS ARE BACKING OUT ACCORDING TO X-RAYS. CURRENTLY WAITING FOR THE LEFT UNIT TO FAIL. BOTH THE DR AND THE HOSP CLAIM THEY DO NOT HAVE THE UNIT. RPTR STATED SHE CONTACTED TMJ IMPLANTS, INC., AND THEY DID NOT HAVE A RECORD OF HER HAVING REC'D CHRISTENSEN TMJ IMPLANTS AND THEY DID NOT HAVE THE UNTI AT THEIR FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHRISTENSEN TMJ IMPLANT TMJ IMPLANTS LZD TMJ IMPLANTS INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death