BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ CONCEPTS

    MDR report key: 2306839 · Received October 18, 2011

    Report

    Report Number
    MW5022729
    Event Type
    Injury
    Date Received
    October 18, 2011
    Date of Event
    March 9, 2009
    Report Date
    October 18, 2011
    Manufacturer
    TMJ SOLUTIONS
    Product Code
    LZD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD THE CHRISTENSEN TMJ ALL METAL JOINTS FOR 11 YEARS AND NEVER HAD ANY PROBLEMS WITH THEM UNTIL THEY WORE OUT. THESE IMPLANTS WERE REPLACED (B)(6) 2009 WITH TMJ CONCEPTS CUSTOM JOINTS. DURING THE SURGERY THE CUSTOMER IMPLANTS DIDN'T FIT RIGHT. SO MY DR HAD TO SAW BONE TO MAKE IT FIT, ADDING AN ADD'L HOUR TO MY SURGERY. MY NEW IMPLANTS WERE CONTAMINATED WITH (B)(6) AND I BELIEVE THE CONTAMINATION OCCURRED AT TMJ CONCEPT'S FACTORY. I HAD 5 PICC LINES AND WAS HOSPITALIZED AND NEARLY DIED DUE TO THIS. ON (B)(6) 2009 THE IMPLANTS WERE REMOVED. I LOST 46 LBS DUE TO ALL OF THIS. I DON'T BELIEVE MY SURGEON OR THE COMPANY FILED A MEDWATCH REPORT REGARDING THIS EVENT. I SPOKE WITH AN FDA STAFF MEMBER SEVERAL TIMES IN (B)(6) WHO STATED SOMEONE WOULD BE IN TOUCH, BUT NO ONE EVER FOLLOWED-UP WITH ME. TODAY I HAVE NO JAWS AND HAVE A 4 - 5 MM OPENING. TMJ CONCEPTS ALMOST COST ME MY LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TMJ CONCEPTS TMJ CUSTOM TOTAL JOINTS LZD TMJ SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| O| R| S