BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ BILATERAL IMPLANTS

    MDR report key: 15220779 · Received August 12, 2022

    Report

    Report Number
    0002031049-2022-00033
    Event Type
    Injury
    Date Received
    August 12, 2022
    Date of Event
    July 29, 2022
    Report Date
    November 3, 2022
    Manufacturer
    TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS
    Product Code
    LZD
    PMA / PMN Number
    P980052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED AS THE SURGEON PROVIDED AN IMAGE THAT SHOWED THAT THE TMJ DEVICES WERE DISLOCATED. THE SURGEON WAS NOT ABLE TO REPLICATE THE DESIGNED PLAN BECAUSE OF THE PATIENT CONDITION. OVERALL, THIS EVENT DOES NOT INDICATE ANY DEVICE FAILURE, MALFUNCTION, OR OTHER PERFORMANCE ISSUES. THE LOT NUMBER HAS BEEN CORRECTED/UPDATE TO T19-0431. H3 OTHER TEXT : DEVICE NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO THE JOINT BEING DISLOCATED AND THE SURGEON COULD NOT GET THE MANDIBLE TO MOVE INTO THE PLANNED POSITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO THE JOINT BEING DISLOCATED AND THE SURGEON COULD NOT GET THE MANDIBLE TO MOVE INTO THE PLANNED POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1995032 TMJ BILATERAL IMPLANTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS LZD TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS T19-0431

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention