BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS

    MDR report key: 11739658 · Received April 28, 2021

    Report

    Report Number
    2031049-2021-00028
    Event Type
    Injury
    Date Received
    April 28, 2021
    Date of Event
    November 5, 2020
    Report Date
    April 28, 2021
    Manufacturer
    TMJ SOLUTIONS, LLC.
    Product Code
    LZD
    UDI-DI
    B004TYYNNNNM0
    PMA / PMN Number
    P980052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT DEVELOPED SEVERE PAIN AFTER RECONSTRUCTION OF THE JOINT WITH TMJ DEVICES. THE PATIENT'S ALLERGY TESTS (LTT, MELISA) CONFIRMED THAT THE PATIENT IS HIGHLY REACTIVE TO NICKEL. THUS, THE SURGEON REMOVED THE PATIENT'S DEVICES AND PLANS TO REPLACE ALL-TITANIUM TMJ DEVICES SOON.

    Description of Event or Problem · 1

    THE SURGEON REMOVED THE PATIENT'S TMJ DEVICES DUE TO MATERIAL SENSITIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634546 PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS TEMPOROMANDIBULAR JOINT IMPLANT LZD TMJ SOLUTIONS, LLC. TYY-NNNNM W45048 B004TYYNNNNM0

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention