BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT-FITTED TMJ LEFT MANDIBULAR COMPONENT

    MDR report key: 10833751 · Received November 12, 2020

    Report

    Report Number
    2031049-2020-00093
    Event Type
    Injury
    Date Received
    November 12, 2020
    Date of Event
    November 4, 2020
    Report Date
    November 12, 2020
    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

    THE PATIENT HAS A LONG HISTORY OF TMJ PAIN AND DYSFUNCTION. THE SURGEON PREVIOUSLY PERFORMED EXPLORATORY SURGERY AND REMOVED SYNOVIAL ENTRAPMENT (MFR. #2031049-2020-00004). HOWEVER, THE PATIENT'S PAIN PERSISTED. THE SURGEON ELECTED TO REMOVE THE LEFT TMJ IMPLANTS, AND REPORTED THAT THE DEVICES DID NOT EXHIBIT ANY HARDWARE FAILURE. MULTIPLE MDR'S WERE SUBMITTED FOR THIS EVENT ( REFERENCE 201349-2020-00092).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292318 PATIENT-FITTED TMJ LEFT MANDIBULAR COMPONENT LEFT MANDIBULAR COMPONENT LZD TMJ SOLUTIONS, INC. TYY-NNNNLM W48085

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention