BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS

    MDR report key: 8053810 · Received November 8, 2018

    Report

    Report Number
    2031049-2018-00037
    Event Type
    Injury
    Date Received
    November 8, 2018
    Date of Event
    October 9, 2018
    Report Date
    November 8, 2018
    Manufacturer
    TMJ SOLUTIONS, INC.
    Product Code
    LZD
    PMA / PMN Number
    P980052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT RECEIVED LEFT TMJ IMPLANTS IN (B)(6) 1998, AND ALREADY HAD RIGHT TMJ IMPLANTS FROM ANOTHER MANUFACTURER. SHE DEVELOPED CHRONIC INFLAMMATION AROUND BOTH JOINTS AND A CT SCAN SHOWED THAT THE PATIENT HAD HETEROTOPIC BONE FORMATION IN BOTH JOINTS. BOTH SIDES WERE FOUND TO BE WELL-FIXATED AND WERE REMOVED. THE SURGEON IS PLANNING ON PLACING REVISION COMPONENTS AT A LATER DATE.

    Description of Event or Problem · 1

    THE PATIENT'S LEFT TMJ DEVICES WERE REMOVED DUE TO HETEROTOPIC BONE GROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890962 PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS TEMPOROMANDIBULAR JOINT IMPLANT LZD TMJ SOLUTIONS, INC. TNN-NNNM W00357

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention