BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NTI

    MDR report key: 11163359 · Received January 12, 2021

    Report

    Report Number
    MW5098794
    Event Type
    Injury
    Date Received
    January 12, 2021
    Date of Event
    April 4, 2019
    Report Date
    January 10, 2021
    Manufacturer
    NDX NATIONAL DENTEX LABS
    Product Code
    OCO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PRIOR TO THE ABOVE DATE, MY (FORMER) DENTIST INFORMED ME THAT DUE TO MY BRUXISM, WHICH IS NIGHTTIME GRINDING, I WAS BEGINNING TO HAVE AN OPEN BITE. AT THIS TIME, IT WAS ONLY ABOUT A MILLIMETER. I ASKED HIM WHAT I COULD DO, AND AT FIRST, HE SAID "NOTHING." THEN HE SAID IF I WANTED TO GET IT FIXED, I COULD GO TO AN ORTHODONTIST. I ASKED HIM IF A NIGHTGUARD WOULD PREVENT IT FROM GETTING WORSE. HE AGREED THAT WOULD HELP. SO, WE STARTED THE PROCESS AND FINALLY AFTER 2 MOS. I RECEIVED MY GUARD. I EXPRESSED CONCERN THAT I DIDN'T THINK IT WAS GOING TO PROTECT MY TEETH AND WAS TOLD THAT IT WOULDN'T BE A PROBLEM. ON APRIL 4 WHEN I HAD SEEN AN ORTHODONTIST BECAUSE I DECIDED I COULDN'T DEAL WITH MY OPEN BITE ANYMORE, I DISCOVERED THAT THE GUARD HAD CAUSED THE OPEN BITE TO WORSEN. THE GUARD WAS SEVERAL MILLIMETERS THICK AND MY OPEN BITE WAS 4 MILLIMETERS OPEN. I THOUGHT IT WAS BECAUSE IT WAS THICK IN THE FRONT. SO THAT DAY I WENT IN AND SPOKE WITH THE DENTIST ABOUT IT. HE AGREED TO CHANGE THE GUARD FOR ME AND TOLD ME MY TEETH MAY CORRECT THEMSELVES. I DID RESEARCH AND DISCOVERED THAT THIS TYPE OF GUARD CALLED AN NTI HAS CAUSED OTHER PEOPLE TO GET AN OPEN BITE AS WELL. IT IS BECAUSE THE DEVICE IS DESIGNED NOT TO COVER ALL OF THE TEETH ON ONE ARCH. THIS IS HOW THESE TYPES ARE MADE. AND SINCE IN MY CASE I ALREADY HAD A SMALL OPEN BITE TO BEGIN WITH, I DON'T UNDERSTAND WHY I WAS GIVEN THIS TYPE OF DEVICE. THEY'RE FOR MIGRAINE SUFFERERS. I HAVE NEVER HAD A MIGRAINE IN MY LIFE. I NEVER RECEIVED ANY WARNING WHATSOEVER. NO VERBAL, NO LITERATURE, NO CONSENT FORM. I FIGURED IT OUT. I WENT TO SEVERAL ORTHODONTISTS AND DENTISTS BECAUSE A COUPLE OF ORTHODONTISTS TOLD ME I NEEDED JAW SURGERY, AND I NEEDED TO KNOW FOR SURE. I WOUND UP ASKING A JAW SURGEON ALSO. I DIDN'T NEED THE JAW SURGERY, BUT IF I HAD, THIS CERTAINLY WOULD HAVE BEEN A LOT MORE SERIOUS. I WANT TO PREVENT THIS FROM HAPPENING TO OTHERS. IF THERE IS A LAW THAT A PATIENT SHOULD BE WARNED, THEN IT HAS BEEN VIOLATED. IF THERE IS NOT A LAW, THEN THERE SHOULD BE ONE. I HAVE HAD TO GET BRACES FOR THIS PROBLEM, AND I HATE IT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54257 NTI MOUTHGUARD, MIGRAINE/TENSION HEADACHE OCO NDX NATIONAL DENTEX LABS NONE

    Patients

    Seq Age Sex Outcome Treatment
    1