BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ CONCEPTS

    MDR report key: 7978763 · Received October 17, 2018

    Report

    Report Number
    MW5080628
    Event Type
    Injury
    Date Received
    October 17, 2018
    Date of Event
    September 19, 2018
    Report Date
    October 16, 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

    PATIENT ORIGINALLY HAD DISC REMOVAL DUE TO TMJ AND SHE ANKYLOSED QUICKLY. THE PATIENT HAD JOINT REPLACEMENTS IN 2016. SHE QUICKLY GREW HETEROTOPIC BONE (WITHIN A YEAR AND A HALF). "I WAS SCHEDULED TO HAVE MY TMJ CONCEPTS OUT BUT THE 1ST DOCTOR TRIED 2X TO REMOVE THE BONE GROWTH. HE ONLY GOT ABOUT 40% OF THE BONE GROWTH AND HE IGNORED THE BONE AROUND MY CONDYLAR HEADS THAT HE HAD ALREADY KNOWN ABOUT FROM MY CT. THE DOCTOR LEFT ME PARALYZED ON BOTH SIDES OF MY FACE FOR MONTHS. THEN HE ABANDONED ME WHEN I WAS COMPLAINING THAT MY PAIN WAS NOT GONE BECAUSE HE DIDN¿T GET ALL THE BONE. I FOUND A NEW DOCTOR AND HE REMOVED MY CONCEPTS JOINTS LAST MONTH. HE REFUSED TO GIVE ME PAIN MEDICINE POST SURGERY AND SAID HE WAS GOING TO DETOX ME FROM MY CHRONIC PAIN MEDS POST SURGERY (WHILE IN THE HOSPITAL AND RECOVERING FROM SURGERY". PATIENT WANTED TO DIE AS THE PAIN WAS AWFUL AFTER HAVING FACIAL AND JAW SURGERY. SHE IS NOW WIRED AND JOINTLESS. SHE IS WAITING FOR NEW JOINTS TO BE MADE. CONCERNED THAT SHE IS AM ALLERGIC TO NICKEL BECAUSE OF THE BONE GROWTH. PATIENT IS ALLERGIC TO COSTUME JEWELRY. DENTIST TOLD ME HE HAS AN INTUITION THAT PATIENT WOULD BE SENSITIVE TO ANY MATERIAL. HE WILL NOT ALLOW PATIENT TO GET THE NICKEL FREE. PATIENT HAD HER ORIGINAL IMPLANTS 2 YEARS AGO. HER SYMPTOMS WERE CLICKING JOINTS AND AN ORAL SURGEON REMOVED HER DISC WITHOUT CONSERVATIVE TREATMENT. THIS IS VERY COMMON IN THE 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 SURROUNDING THE TMJ CONCEPTS AND THE SURGEON FAILED TO REMOVE IT ALL. THE DOCTOR 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 DOCTOR DID NOT GIVE HER ADEQUATE PAIN MEDS POST SURGERY. SURGEON THREATENS TO KEEP HER JOINTLESS INDEFINITELY. PAIN MANAGEMENT RECOMMENDED THAT SHE RECEIVE MEDICINE FOR PAIN BUT THE SURGEON DENIED IT. THE PATIENT IS BEING IMPLANTED WITH THE CHROME/NICKEL DESPITE A POSSIBLE ALLERGY TO 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. PATIENT IS ALREADY 28 LBS UNDERWEIGHT. THIS PATIENT IS AFRAID TO REPORT AS SHE HAS ALREADY BEEN ABANDONED BY HER PREVIOUS SURGEON. THE CURRENT DOCTOR SENT HER A LETTER STATING HE WILL ESSENTIALLY HOLD HER HOSTAGE UNTIL SHE PEES CLEAN AND IS FREE OF ANY NARCOTICS. HE ALSO SAID HE WILL KEEP HER JOINTLESS UNTIL SHE IS NOT TAKING ANY PAIN MEDICINE. THIS PATIENT HAS CHRONIC PAIN. SHE IS TERRIFIED OF REMAINING JOINTLESS. SHE IS WIRED AND ALREADY 28 LBS UNDERWEIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817181 TMJ CONCEPTS JOINT, TEMPOROMANDIBULAR IMPLANT LZD TMJ SOLUTIONS INC.

    Patients

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