BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ UNILATERAL IMPLANTS (BUNDLED COST)

    MDR report key: 15491143 · Received September 27, 2022

    Report

    Report Number
    0002031049-2022-00043
    Event Type
    Injury
    Date Received
    September 27, 2022
    Date of Event
    August 30, 2022
    Report Date
    December 15, 2022
    Manufacturer
    TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS
    Product Code
    LZD
    PMA / PMN Number
    P980052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 OPERATIVE NOTES THAT SHOWED THAT THE UNILATERAL DEVICE WAS REMOVED. THE CORRECTED DATA IS AS FOLLOWS: LOT NUMBER REPORTED ON EMDR INITIAL WAS T-21-1031 AND LATER FOUND TO BE LOT NUMBER T-20-1031. BASED ON THE INVESTIGATION, THERE IS NO INDICATION OF AN INCORRECTLY WORKING PRODUCT OR ANY DESIGN, MATERIAL, OR MANUFACTURING-RELATED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD TMJ CONCEPTS PROTHESIS IMPLANTED AND RECENTLY COMPLAINED OF MALOCCLUSION AND A HEARING LOUD POP. SURGEON IS LIKELY TO PERFORM A SECOND SURGERY TO REMOVE AND REVISE THE DEVICES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD TMJ CONCEPTS PROTHESIS IMPLANTED AND RECENTLY COMPLAINED OF MALOCCLUSION AND A HEARING LOUD POP. SURGEON IS LIKELY TO PERFORM A SECOND SURGERY TO REMOVE AND REVISE THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2077342 TMJ UNILATERAL IMPLANTS (BUNDLED COST) PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS LZD TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS T-20-1031

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention