BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS

    MDR report key: 7976437 · Received October 17, 2018

    Report

    Report Number
    2031049-2018-00030
    Event Type
    Injury
    Date Received
    October 17, 2018
    Date of Event
    September 19, 2018
    Report Date
    October 17, 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 BILATERAL IMPLANTS IN (B)(6) 2014. THE SURGEON IS PLANNING ON PLACING REVISION COMPONENTS AT A LATER DATE.

    Description of Event or Problem · 1

    THE PATIENT'S LEFT AND RIGHT TMJ DEVICES WERE REMOVED DUE TO SIGNIFICANT HETEROTOPIC BONE FORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813948 PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS TEMPOROMANDIBULAR JOINT IMPLANT LZD TMJ SOLUTIONS, INC. TYY-NNNM W29270

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention