BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NTI SPLINT

    MDR report key: 471018 · Received July 3, 2003

    Report

    Report Number
    MW1028944
    Event Type
    Injury
    Date Received
    July 3, 2003
    Report Date
    July 3, 2003
    Manufacturer
    NTI CLENCHING SUPPRESSION SYSTEM
    Product Code
    LQZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE WILL REPOSITION THE CONDYLAR, IT WILL NOT STOP MIGRAINES, IT TOOK OUT PT'S TWO FRONT CROWN TEETH, IT CAUSES TOOTH MOVEMENT, JOINT STRAIN, AND THAT ALL PTS SHOULD BE MADE AWARE OF THE CONTRA-INDICATIONS FOR IT. IN 08/2001, NTI TOOK OUT THE PT'S 2 FRONT TEETH. THEY HAD PAID OVER $10,000.00 TO FIX THEIR MOUTH AND PT IS STILL IN PAIN. THIS DEVICE IS HARMFUL - DANGEROUS AND IT IS NOT THERAPEUTIC. PT HAD TO HAVE SURGERY TO UNDO THE HARM THAT WAS CAUSED BY THE NTI SPLINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NTI SPLINT NOCICEPTIVE TRIGEMINAL INHIBITION REFLEX DEVICE LQZ NTI CLENCHING SUPPRESSION SYSTEM * *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other| R