BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS

    MDR report key: 8171889 · Received December 17, 2018

    Report

    Report Number
    2031049-2018-00045
    Event Type
    Injury
    Date Received
    December 17, 2018
    Date of Event
    November 20, 2018
    Report Date
    December 17, 2018
    Manufacturer
    TMJ SOLUTIONS, INC.
    Product Code
    LZD
    UDI-DI
    B004TYYNNNNM0
    PMA / PMN Number
    P980052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT RECEIVED BILATERAL TMJ IMPLANTS IN (B)(6) 2018. A WEEK AFTER SURGERY, THE PATIENT STARTED COMPLAINING OF PAIN AND SWELLING ON THE LEFT SIDE. THE PATIENT WAS TAKEN INTO SURGERY WITH A SIGNIFICANT ABSCESS AND THE LEFT TMJ IMPLANTS WERE AGGRESSIVELY SCRUBBED AND IRRIGATED WITH AN ANTIBIOTIC SOLUTION. THE PATIENT HAD DRAINS PLACED, AND HE DID WELL FOR TWO MONTHS. THEN AFTER A RECURRENT ABSCESS, THE SURGEON ELECTED TO REMOVE THE LEFT TMJ DEVICES AND PLACED AN ANTIBIOTIC SPACER. MICROBIOLOGY TESTING SHOWED GROWTH OF PREVOTELLA DENTICOLA AND STREPTOCOCCUS CONSTELLATUS. THE SURGEON PLANS ON PLACING REVISION COMPONENTS AFTER THE INFECTION HAS BEEN RESOLVED.

    Description of Event or Problem · 1

    THE PATIENT'S LEFT TMJ DEVICES WERE REMOVED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008505 PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS TEMPOROMANDIBULAR JOINT IMPLANT LZD TMJ SOLUTIONS, INC. TYY-NNNNM W44218 B004TYYNNNNM0

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention