BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ BILATERAL IMPLANTS

    MDR report key: 15298235 · Received August 25, 2022

    Report

    Report Number
    0002031049-2022-00039
    Event Type
    Injury
    Date Received
    August 25, 2022
    Date of Event
    August 17, 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
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 THE PATIENT¿S CT SCAN AND STONE MODELS, WHICH SHOWED THE PATIENT¿S CURRENT OCCLUSION, AND AN ORDER FOR NEW DEVICES WAS SUBMITTED. THE CORRECTED DATA FROM INITIAL EMDR WAS THE UNKNOWN LOT NUMBER BEING CORRECTED TO T-16-0792. STRYKER'S CLINICAL CONSULTANT REVIEWED THE CT SCAN, COMPARED IT WITH THE PROPOSAL PHOTOS, AND REPORTED THAT THE CONDYLE RESECTION WAS LOWER THAN PLANNED. OVERALL, THE TMJ DEVICES WERE DESIGNED AND MANUFACTURED PER SPECIFICATIONS. NO INDICATION WAS FOUND OF A DEVICE FAILURE, MALFUNCTION, OR OTHER PERFORMANCE ISSUES. A POSSIBLE CONTRIBUTING FACTOR THAT COULD BE IDENTIFIED IS THE SURGICAL TECHNIQUE OF THE ORIGINAL IMPLANTING SURGEON NOT PLACING THE IMPLANTS IN THE INTENDED POSITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ANTERIOR OPEN BITE AND THERE WILL BE A SECOND SURGERY PERFORMED TO REVISE THE MANDIBULAR COMPONENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ANTERIOR OPEN BITE AND THERE WILL BE A SECOND SURGERY PERFORMED TO REVISE THE MANDIBULAR COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417239 TMJ BILATERAL IMPLANTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS LZD TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS T16-0792

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention