BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS

    MDR report key: 8011872 · Received October 28, 2018

    Report

    Report Number
    2031049-2018-00035
    Event Type
    Injury
    Date Received
    October 28, 2018
    Date of Event
    September 28, 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
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT RECEIVED BILATERAL IMPLANTS IN (B)(6) 2013. THE PATIENT HAD A 2.5 YEAR HISTORY OF INTERMITTENT RIGHT-SIDED FACIAL SWELLING, WHICH WAS ATTRIBUTED TO A CHRONIC BIOFILM INFECTION. SHE WAS ON MULTIPLE COURSES OF ANTIBIOTICS WHICH FAILED TO RESOLVE THE INFECTION. THE SURGEON REMOVED THE RIGHT TMJ IMPLANTS IN (B)(6) 2018 AND IS PLANNING ON PLACING REVISION IMPLANTS ONCE THE INFECTION HAS BEEN RESOLVED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851742 PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS TEMPOROMANDIBULAR JOINT IMPLANT LZD TMJ SOLUTIONS, INC. TYY-NNNM W25457

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention