BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ CONCEPTS

    MDR report key: 7957051 · Received October 10, 2018

    Report

    Report Number
    MW5080480
    Event Type
    Injury
    Date Received
    October 10, 2018
    Date of Event
    October 7, 2016
    Report Date
    October 8, 2018
    Manufacturer
    TMJ CONCEPTS / TMJ SOLUTIONS, INC.
    Product Code
    LZD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SHE HAD HETEROTOPIC BONE AND TOTAL JOINTS REMOVED AND THE DR REFUSED TO PROVIDE PAIN MEDICINE. HE THREATENED TO LEAVE HER JOINTLESS INDEFINITELY IF SHE TAKES ANY PAIN MEDICINE WHILE WAITING FOR HER NEW TOTAL JOINT. HE SAYS HE IS MILITANT ABOUT THIS (I HAVE IN WRITING). SHE HAD HER ORIGINAL IMPLANTS 2 YEARS AGO. PT IS NOW (B)(6). HER SYMPTOMS WERE CLICKING JOINTS AND AN ORAL SURGEON REMOVED HER DISCS WITHOUT CONSERVATIVE TREATMENT. THERE IS VERY COMMON IN THIS FIELD WITHOUT STANDARDS. SHE QUICKLY ANKYLOSED AND WAS CONSIDERED END STAGE, SO SHE WAS IMPLANTED WITH TMJ CONCEPTS. (B)(6) 2018 SHE HAD SURGERY TO REMOVE HETEROTOPIC BONE AND THE SURGEON FAILED TO REMOVE IT ALL. THE DR ABANDONED HER. SHE WENT TO A NEW SURGEON AND HE REMOVED THE OLD TMJ CONCEPTS JOINTS THAT STILL HAD HETEROTOPIC BONE GROWING ALL OVER THE IMPLANTS. THE DR DID NOT GIVE HER ANY PAIN MEDS POST SURGERY. PAIN MGMT RECOMMENDED THAT SHE RECEIVES MEDICINE FOR PAIN BUT THE SURGEON DENIED IT. THE PT HAS AN ALLERGY TO NICKEL AND WAS STILL IMPLANTED THE TMJ CONCEPTS WITH NICKEL. THE SURGEON THREATENS HER WITH KEEPING HER JOINTLESS IF SHE TAKES PAIN MEDS. HE GAVE HER NO SYRINGES OR COUNSELING ON HOW TO EAT WHILE JOINTLESS. PT IS ALREADY UNDERWEIGHT. THIS PT IS AFRAID TO REPORT AS SHE HAS ALREADY BEEN ABANDONED BY HER PREVIOUS SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793336 TMJ CONCEPTS JOINT TEMPOROMANDIBULAR IMPLANT LZD TMJ CONCEPTS / TMJ SOLUTIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| R| S