BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NTI

    MDR report key: 1306026 · Received February 4, 2009

    Report

    Report Number
    MW5009881
    Event Type
    Injury
    Date Received
    February 4, 2009
    Date of Event
    July 14, 2008
    Report Date
    February 4, 2009
    Manufacturer
    NTI
    Product Code
    LQZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2006, I WAS PRESCRIBED AN NTI NIGHTGUARD BY MY DENTIST, DR. BOB KOENITZER, TO HELP WITH GUM RECESSION DUE TO BRUXISM. IN 2007, I TELL DR THAT "MY BITE IS OFF" AND HE TELLS ME THAT IT IS NORMAL AND NO MEASUREMENTS ARE TAKEN. I SEE HIM AGAIN FOR A CLEANING APPROX THREE MONTHS LATER, AND NO MEASUREMENTS ARE TAKEN OR INQUIRY ABOUT MY BITE IS MADE. I SEE HIM AGAIN FOR A CLEANING FOUR MONTHS LATER, AND MENTION THAT MY JAW IS NOW HURTING. AGAIN, NOTHING ABOUT MY TREATMENT IS CHECKED IN 2008, IT IS NOTED IN MY FILE THAT I AM STILL WEARING THE NTI DEVICE NIGHTLY. FOUR MONTHS LATER, I REQUIRE AN EMERGENCY EXAM BECAUSE MY JAW IS IN UNBEARABLE PAIN, AND NOW WHEN I PUT THE NTI DEVICE IN, MY MOLARS IN THE BACK CAN NOW TOUCH. MY BITE IS NOW AN OPEN BITE. I WAS IN EXCRUCIATING PAIN FOR 3 MONTHS, NOW HAVE A SPEECH IMPEDIMENT, AM UNABLE TO EAT IN A NORMAL WAY, AND AM AT RISK FOR LOSING MY TWO TOP BACK MOLARS DUE TO THE MALOCCLUSION. DOSE OR AMOUNT: NA. DATES OF USE: 2006 - 2008. DIAGNOSIS OR REASON FOR USE: GUM RECESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NTI NIGHTGUARD LQZ NTI

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Disability