BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NTI-TSS DENTAL DEVICE

    MDR report key: 551955 · Received September 9, 2004

    Report

    Report Number
    MW1033519
    Event Type
    Injury
    Date Received
    September 9, 2004
    Date of Event
    June 25, 2004
    Report Date
    September 9, 2004
    Manufacturer
    KELLER LABS
    Product Code
    LQZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR WAS GIVEN A CUSTOM MADE "NTI-TSS" DENTAL DEVICE BY THEIR DENTIST TO HELP WITH BRUXISM. IT WAS SUPPOSED TO STOP THEM FROM GRINDING. THE NTI-TSS WEBSITE STATES THAT THIS PRODUCT WORKS FOR EVERYONE; THEIR DENTIST SAID THAT THEY HAVE USED IT WITH 100 PTS WITH GOOD RESULTS. WELL, THE RESULT FOR RPTR WAS THAT THE DEVICE WAS NOT ONLY INEFFECTIVE BUT HAS DONE DAMAGE TO THEIR JAW ALIGNMENT, BITE, AND FACIAL APPEARANCE. THE DEVICE CAUSED THEM TO GRIND THEIR FRONT TEETH INSTEAD OF THEIR MOLARS. EVEN THOUGH RPTR ONLY WORE IT FOR TWO WEEKS, RPTR'S JAW AND THEIR BITE HAVE NOT RETURNED TO "NORMAL." DURING THE TWO WEEKS RPTR WORE IT RPTR SUFFERED EXTREME HEADACHES, FACIAL PAIN, AND THEIR FRONT TEETH LOOSENNED. RPTR HAS BEEN BACK TO THEIR DENTIST NUMEROUS TIMES BUT THEY DON'T UNDERSTAND WHY THIS HAS HAPPENNED AND DOESN'T KNOW WHAT TO DO ABOUT IT. RPTR'S TEETH ARE ACTUALLY MOVING POSITION SINCE RPTR CAN BARELY BITE DOWN WITHOUT FORCING THEIR LOWER JAW BACK. THEIR FRONT LOWER TEETH ARE SHIFTING BACK BECAUSE THEY ARE CONSTANTLY PUSHING AGAINST THEIR UPPER TEETH. EATING AND CHEWING IS CHALLENGING SINCE THEY CAN'T ACTUALLY TOUCH THEIR UPPER AND LOWER MOLARS TOGETHER WITHOUT EFFORT. THEREFORE, RPTR'S LOWER JAW SPASMS WHEN THEY CHEW. THE NTI-TSS WEBSITE CLAIMS THAT THERE HAVE BEEN NO CLAIMS AGAINST IT. RPTR IS NOT THE ONLY ONE HARMED BY THIS DEVICE. PLEASE WARN THE PUBLIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NTI-TSS DENTAL DEVICE DENTAL DEVICE TO STOP NIGHTTIME CLENCHING & GRINDING LQZ KELLER LABS NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other| R