BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT-FITTED TMJ LEFT MANDIBULAR COMPONENT

    MDR report key: 9690010 · Received February 10, 2020

    Report

    Report Number
    2031049-2020-00006
    Event Type
    Malfunction
    Date Received
    February 10, 2020
    Date of Event
    September 3, 2020
    Report Date
    June 8, 2021
    Manufacturer
    TMJ SOLUTIONS, INC.
    Product Code
    LZD
    PMA / PMN Number
    P980052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS UNABLE TO MAINTAIN THE SURGEON'S PLANNED OCCLUSION AND THE PATIENT DISLOCATED. THE SURGEON ATTEMPTED TO REDUCE THE PATIENT'S DISLOCATION, BUT THE MANDIBULAR COMPONENT CONTINUED TO DISLOCATE. THE SURGEON PLANS ON PLACING A REVISION MANDIBULAR COMPONENT TO ACCOMMODATE THE PATIENT'S CURRENT OCCLUSION. THE DEVICE REMAINS IMPLANTED AT THIS TIME; HOWEVER, A SUPPLEMENT TO THIS MDR WILL BE SUBMITTED FOR THE REVISION SURGERY.

    Description of Event or Problem · 1

    THE PATIENT'S LEFT MANDIBULAR COMPONENT IS DISLOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148849 PATIENT-FITTED TMJ LEFT MANDIBULAR COMPONENT LEFT MANDIBULAR COMPONENT LZD TMJ SOLUTIONS, INC. TYY-NNNLM W28210

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other