BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ SOLUTIONS

    MDR report key: 4080814 · Received September 6, 2014

    Report

    Report Number
    MW5038118
    Event Type
    Injury
    Date Received
    September 6, 2014
    Date of Event
    February 19, 2014
    Report Date
    September 6, 2014
    Manufacturer
    TMJ CONCEPTS
    Product Code
    LZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT HAD CONFIRMED BIOFILM INFECTION OF THE RIGHT TMJ CONCEPTS JOINT. STAPH COAG NEG AND P.ACNES. CONFIRMED 5-13. REMOVED (B)(6)- TREATED WITH DAPTOMYCIN PICC LINE FOR 9 WEEKS. NEW IMPLANT PLACED (B)(6) 2014. PT REMAINED ON PICC LINE UNTIL (B)(6). BIOFILM RETURNED. PT HAS LIMITED OPENING. PAIN AND SWELLING. PLACED ANOTHER PICC LINE UNTIL (B)(6) 2014 AND NOW ON SUPPRESSIVE ANTIBIOTICS. PT'S SYMPTOMS CLEARED WITH PICC LINE. PT IS NOW ON ORAL SUPPRESSIVE ANTIBIOTICS. PT IN SEVERE PAIN AND IS UNABLE TO WORK FULL TIME. IMPLANT IS NOT ALLOWING FULL OPENING AND IS JARRING. PT HAD ORIGINAL DEVICE IMPLANTED 8-10. SYMPTOMS OF INFECTION BEGAN SHORTLY AFTER IMPLANTATION. WAS REMOVED AFTER 30-40 CYCLES OF ANTIBIOTICS. NEW IMPLANT PUT IN (B)(6) 2014. PT ON SUPPRESSIVE BACTRIM ANTIBIOTICS WITH PICC LINE INVANZ (ALTERNATING). REASON FOR USE: JAW JOINT ANKYLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546984 TMJ SOLUTIONS TMJ IMPLANT LZD TMJ CONCEPTS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| O| R| S