BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNISMILE CLEAR ALIGNERS

    MDR report key: 22494419 · Received July 14, 2025

    Report

    Report Number
    MW5172551
    Event Type
    Injury
    Date Received
    July 14, 2025
    Date of Event
    July 2, 2025
    Report Date
    July 8, 2025
    Manufacturer
    VITANG TECHNOLOGY LLC.
    Product Code
    NXC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY DENTIST IS HAVING ME UNDERGO CLEAR ALIGNER TREATMENT TO FIX MY DENTAL BITE TO PREVENT A FRACTURE OF MY BOTTOM TOOTH FROM GETTING WORSE, AND THE FRACTURE HAS NOW EXTENDED FROM HALFWAY DOWN MY TOOTH TO BELOW THE GUMLINE AFTER ONLY 3 MONTHS OF TREATMENT. I MAY NOW HAVE TO UNDERGO GETTING A CROWN, ROOT CANAL, OR EXTRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154372 UNISMILE CLEAR ALIGNERS ALIGNER, SEQUENTIAL NXC VITANG TECHNOLOGY LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female Required Intervention ALBUTEROL SULFATE.| ALLEGRA.| L-LYSINE.| MONTELUKAST.| SYMBICORT, ALBUTEROL SULFATE, ALLEGRA.| WOMEN'S DAILY MULTIVITAMIN.