BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ BONE SCREW 2.0MM X 8MM

    MDR report key: 16870682 · Received May 4, 2023

    Report

    Report Number
    0002031049-2023-00030
    Event Type
    Injury
    Date Received
    May 4, 2023
    Date of Event
    April 19, 2023
    Report Date
    July 21, 2023
    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
    MO, 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

    UPDATE: H6. CORRECTION: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THIS COMPLAINT # (B)(4) (61-2008) HAS BEEN ENTERED, BECAUSE THIS TYPE OF SCREW WAS LISTED IN THE TMJ CONCEPTS PLAN (T18-0634). THE BROKEN SCREWS REPORTED WERE IDENTIFIED TO BE 61-2010 (COMPLAINT # (B)(4)) ON THE POSTOPERATIVE IMAGES. THE TYPE OF SCREW (61-2008) OF THIS CURRENT COMPLAINT HAS NOT BEEN USED IN THE CASE AND THEREFORE, IT WAS CONSIDERED TO BE CONCOMITANT AND WILL BE UPDATED IN THE RECORD. H3 OTHER TEXT : IMPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCAN SHOWED THE IMPLANT WAS DISLOCATED AND THREE SCREWS WERE BROKEN. THERE WILL BE A REVISION SURGERY PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCAN SHOWED THE IMPLANT WAS DISLOCATED AND THREE SCREWS WERE BROKEN. THERE WILL BE A REVISION SURGERY PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621636 TMJ BONE SCREW 2.0MM X 8MM PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS LZD TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS 61-2008

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention