BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ CONCEPTS TOTAL JOINT

    MDR report key: 8008880 · Received October 25, 2018

    Report

    Report Number
    MW5080815
    Event Type
    Injury
    Date Received
    October 25, 2018
    Date of Event
    September 23, 2015
    Report Date
    October 22, 2018
    Manufacturer
    TMJ SOLUTIONS, INC.
    Product Code
    LZD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD A UNILATERAL TMJ CONCEPTS DEVICE PUT IN ON (B)(6) 2015. DEVELOPED NUMBNESS FROM HER FOREHEAD TO CHIN. HER EYE WOULD NOT SHUT ALL OF THE WAY. IN 2016 THE DR SAY HETEROTOPIC BONE GROWING ON THE IMPLANT. SHE IS NOW EXPERIENCING MORE NUMBNESS, PALSY, MIGRAINES, SHARP STABBING PAIN, FACE DROOPING. SHE EXPERIENCES A METALLIC TASTE IN HER MOUTH SINCE THE IMPLANT. TMJ CONCEPTS SAID SHE MUST GET THE BONE REMOVED AND SHE HAS A 50/50 CHANCE OF SAVING THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844288 TMJ CONCEPTS TOTAL JOINT JOINT, TEMPOROMANDIBULAR, IMPLANT LZD TMJ SOLUTIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S