BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOOTH ALIGNER

    MDR report key: 20599163 · Received November 1, 2024

    Report

    Report Number
    MW5162103
    Event Type
    Injury
    Date Received
    November 1, 2024
    Report Date
    October 30, 2024
    Manufacturer
    UNK
    Product Code
    NXC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CLEAR ALIGNER ORTHODONTIC THERAPY WITHOUT A DENTAL EXAM OR X-RAY KNOWN AS DO IT YOURSELF (DIY) ORTHODONTICS. UPON REMOVAL OF A TREATMENT ALIGNER, THE PATIENT LOST A PERMANENT TOOTH. THIS SHOULD NEVER EVER HAPPEN AND WOULD NOT WITH PROPER EXAMINATION FROM A QUALIFIED DENTAL PROFESSIONAL, NAMELY AN ORTHODONTIST WHOSE SPECIALTY THIS IS. SMILE DIRECT CLUB USED ELIMINATION OF THE DIAGNOSING DR TO OFFER "CHEAP TREATMENT " ALTERNATIVES FOR ORTHODONTIC PATIENTS. THERE WAS UNDIAGNOSED PERIODONTAL DISEASE THAT WAS NEVER FOUND OR ADDRESSED AS THIS PATIENT WAS NEVER SEEN BY A DENTAL PROFESSIONAL UNTIL AFTER THE DAMAGE OCCURRED. I HAVE HAD A DOZEN FAILED CASES SHOW IN MY OFFICE FOR RETREATMENT. DIY ORTHODONTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461686 TOOTH ALIGNER ALIGNER, SEQUENTIAL NXC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Disability