BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS

    MDR report key: 8011849 · Received October 28, 2018

    Report

    Report Number
    2031049-2018-00036
    Event Type
    Injury
    Date Received
    October 28, 2018
    Date of Event
    May 3, 2018
    Report Date
    October 26, 2018
    Manufacturer
    TMJ SOLUTIONS, INC.
    Product Code
    LZD
    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 IMPLANTS IN (B)(6) 2006. THE PATIENT STARTED TO NOTICE SYMPTOMS OF INTERMITTENT PAIN AND PREAURICULAR SWELLING IN (B)(6) 2017. IN (B)(6) 2018, THE PATIENT HAD A DEBRIDEMENT SURGERY OF THE LEFT TM JOINT WITH AN INSERTION OF A PICC LINE FOR THE ADMINISTRATION OF INTRAVENOUS ANTIBIOTICS. THE LEFT TMJ IMPLANTS WERE LATER REMOVED IN (B)(6) 2018 DUE TO THE PATIENT'S ONGOING SYMPTOMS. TISSUE SAMPLES WERE TAKEN FOR MICROBIOLOGICAL TESTING, AND THE RESULTS SHOWED GROWTH OF P. ACNES. THE SURGEON IS PLANNING ON PLACING REVISION COMPONENTS ONCE THE INFECTION IS RESOLVED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853026 PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS TEMPOROMANDIBULAR JOINT IMPLANT LZD TMJ SOLUTIONS, INC. TYY-NNNM W10604

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention