BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT-FITTED TMJ LEFT MANDIBULAR COMPONENT

    MDR report key: 12197726 · Received July 20, 2021

    Report

    Report Number
    2031049-2021-00049
    Event Type
    Injury
    Date Received
    July 20, 2021
    Date of Event
    September 17, 2021
    Report Date
    October 27, 2021
    Manufacturer
    TMJ SOLUTIONS, LLC.
    Product Code
    LZD
    UDI-DI
    B004TYYNNNNLM0
    PMA / PMN Number
    P980052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE SURGEON REMOVED THE LEFT TMJ DEVICES AND PLANS TO REVISION DEVICES.

    Additional Manufacturer Narrative · 1

    THE SURGEON PLANS TO REMOVE AND REPLACE THE MANDIBULAR COMPONENT WITH AN ALL TITANIUM DEVICE.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED TO THE SURGEON WITH PAIN, REDNESS, AND SWELLING. THE PATIENT'S METAL ALLERGY TESTS (LTT) ARE POSITIVE FOR NICKEL SENSITIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1091338 PATIENT-FITTED TMJ LEFT MANDIBULAR COMPONENT LEFT MANADIBULAR COMPONENT LZD TMJ SOLUTIONS, LLC. TYY-NNNNLM W58875 B004TYYNNNNLM0

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention