BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ CONCEPTS

    MDR report key: 4080812 · Received September 5, 2014

    Report

    Report Number
    MW5038117
    Event Type
    Injury
    Date Received
    September 5, 2014
    Date of Event
    August 17, 2013
    Report Date
    September 5, 2014
    Manufacturer
    TMJ CONCEPTS
    Product Code
    LZD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PT HAD A NEW LEFT SIDE CONDYLE IMPLANTED IN (B)(6) 2013. A FEW DAYS AFTER THE NEW IMPLANT WAS PUT IN, THE PT EXPERIENCED EXTREME PAIN AND SWELLING. SEVEN DAYS AFTER THE SURGERY THE INCISION OPENED UP AND STARTED DRAINING. SHE REPORTS THE DRAINING STARTED OUT AS PUS AND THEN CHANGED TO CLEAR, YELLOW, GREEN AND RED DRAINING. ON (B)(6) 2013, THE PT HAD THE DRAINING CULTURED BY A LOCAL DOCTOR. THE CULTURE REPORT STATES A FEW WBCS ON THE GRAM STAIN AND THE ORGANISMS COAG. (B)(6) WERE PRESENT. IN (B)(6) 2014, THE PT HAD A CT SCAN THAT REVEALED THE LEFT CONDYLE PROSTHESES WAS MALPOSITIONED. THE PT ALSO REPORTS HER C-REACTIVE PROTEIN, C4A, AND EBV HAVE BEEN ELEVATED. SHE HAS REPORTED CONTINUOUS LOW GRADE FEVERS, FATIGUE, LEFT SIDE SINUS PAIN AND SWELLING, LEFT SIDE EAR PAIN AND HEADACHES, DIZZINESS, BLURRED VISION, AND MUSCLE ACHES/PAINS THROUGHOUT HER BODY. SHE HAS RECENTLY DEVELOPED THYROID ISSUES WHICH IS THOUGHT TO BE FROM THESE INFECTIONS. SHE HAS BEEN ON OVER 10 ANTIBIOTICS OVER THE YEAR AND NOW HAS REPORTED SYSTEMIC CANDIDA AND ON 3 ANTIFUNGAL MEDS ALONG WITH SINUS MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543276 TMJ CONCEPTS TMJ IMPLANT LZD TMJ CONCEPTS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention| S