BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ BILATERAL IMPLANTS

    MDR report key: 15620750 · Received October 17, 2022

    Report

    Report Number
    0002031049-2022-00047
    Event Type
    Injury
    Date Received
    October 17, 2022
    Date of Event
    September 21, 2022
    Report Date
    December 15, 2022
    Manufacturer
    TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS
    Product Code
    LZD
    PMA / PMN Number
    P980052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT YET BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED AS THE SURGEON PLACED AN ORDER FOR PURCHASING BILATERAL TMJ SET ON THE ID PORTAL AND RETURNED THE LEFT TMJ EXPLANT DEVICES. THE IMPLANTING SURGEON REPORTED DIFFICULTY PLACING THE CONDYLAR COMPONENT ON THE RIGHT SIDE DUE TO THE PATIENT'S BONE QUALITY. THE ENGINEERING DEPARTMENT REVIEWED THE IMAGING AND REPORTED THAT THE BONE QUALITY WAS MARGINAL IN THE FOSSAE, WHICH HAD BEEN REMODELED. THE MANDIBLE SHOULD BE REPOSITIONED MORE ANTERIORLY, AND THIS CAN ONLY BE ACHIEVED BY REMOVING THE LEFT TMJ DEVICES TO GET THE MANDIBLE IN AN EFFICIENT POSITION. HOWEVER, THE JAW WAS SLIGHTLY YAWED, AND A MINOR CORRECTION WAS NEEDED FOR SYMMETRY. THIS COMPLAINT ADDRESSES THE REMOVAL OF THE LEFT SIDE DEVICES. THE REMOVAL OF THE RIGHT-SIDE DEVICES IS AD-DRESSED IN PI 2728749. CORRECTED DATA: THE CATALOG NUMBER ORIGINALLY REPORTED WAS CHG010 AND IT WAS LATER FOUND TO BE CHG020. ADDITIONALLY, THE LOT NUMBER WAS CORRECTED TO T16-0271. OVERALL, THE REMOVAL OF DEVICES WAS TO THE SYMMETRY ADVANCEMENT OF THE MANDIBLE, AND IT COULD ONLY BE ACHIEVED WHEN BOTH SIDES ARE REVISED, SO THIS EVENT IS UNRELATED TO TMJ DEVICE FAILURE, MALFUNCTION, OR OTHER PERFORMANCE ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED IN ORDER TO ACHIEVE THE MANDIBULAR POSITION WANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED IN ORDER TO ACHIEVE THE MANDIBULAR POSITION WANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2352575 TMJ BILATERAL IMPLANTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS LZD TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS T16-0271LF AND LM

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention