BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIGNER

    MDR report key: 24146819 · Received January 22, 2026

    Report

    Report Number
    MW5182643
    Event Type
    Injury
    Date Received
    January 22, 2026
    Date of Event
    December 18, 2024
    Report Date
    January 16, 2026
    Manufacturer
    DENTSPLY SIRONA INC.
    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

    I USED BYTE ALIGNERS TO STRAIGHTEN MY TEETH. I COMPLETED THE PROCESS AND EVERYTHING SEEMED FINE. I RECEIVED A NOTIFICATION FROM BYTE THAT THEIR ALIGNERS WERE CAUSING PROBLEMS AND THAT IF I HAD EXPERIENCED ANY ISSUES I SHOULD REACH OUT TO THEM. I REACHED OUT TO THEM BECAUSE MY DENTIST TOLD ME THAT I HAVE BONE DETERIORATION AND REQUIRE PERIODONTAL CLEANINGS NOW. I ATTEMPTED TO COMMUNICATE TO THEM WHAT WAS GOING ON BUT THEY REFUSED TO COMMUNICATE WITH ME. THE REFUSED TO PROVIDE ME A COPY OF MY CONTRACT WHICH I SIGNED WITH THEM AT THE BEGINNING OF MY TREATMENT. I HAVE NEVER BEEN DIAGNOSED WITH EITHER ISSUE PRIOR TO USING BYTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214311 ALIGNER ALIGNER, SEQUENTIAL NXC DENTSPLY SIRONA INC. 000047465695 RT-L7

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Required Intervention| O