BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS

    MDR report key: 7976438 · Received October 17, 2018

    Report

    Report Number
    2031049-2018-00031
    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

    THE PATIENT RECEIVED BILATERAL IMPLANTS IN (B)(6) 2011. THE SURGEON REPORTED THAT AT THE TIME OF THE DEBRIDEMENT SURGERY THE COMPONENTS WERE WELL-FIXED. THE RIGHT FOSSA COMPONENT WAS TEMPORARILY REPLACED WITH A CEMENT SPACER, AND THE RIGHT MANDIBULAR COMPONENT AND THE LEFT TMJ DEVICES ARE STILL IN PLACE. THE SURGEON PLANS ON PLACING A REVISION RIGHT FOSSA COMPONENT AT A LATER TIME.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A DEBRIDEMENT SURGERY ON THE PATIENT'S LEFT AND RIGHT TMJ DUE TO SIGNIFICANT HETEROTOPIC BONE FORMATION. THE RIGHT FOSSA COMPONENT WAS EXPLANTED DURING THE DEBRIDEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813952 PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS TEMPOROMANDIBULAR JOINT IMPLANT LZD TMJ SOLUTIONS, INC. TYY-NNNRF W19032

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention