BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BYTE NIGHT ALIGNERS

    MDR report key: 21194492 · Received January 20, 2025

    Report

    Report Number
    3014845255-2024-03723
    Event Type
    Injury
    Date Received
    January 20, 2025
    Report Date
    November 26, 2025
    Manufacturer
    STRAIGHT SMILE, LLC
    Product Code
    NXC
    UDI-DI
    00850017524170
    PMA / PMN Number
    K230199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21 CFR PART 803.

    Additional Manufacturer Narrative · 0

    A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    Description of Event or Problem · 0

    WHILE USING NIGHT ALIGNERS THE PATIENT REPORTED, "THIS IS VERY DISAPPOINTING. SINCE I WILL NOT BE USING THEM DUE TO THE FACT THAT I NEED TO FIX THE LARGE SPACE THAT BYTE ALIGNERS HAVE CAUSED I JUST STARTED THE LAST ALIGNERS OF THE 3 EXTRA THAT BYTE SENT ME AND MY OPEN MOUTH BITE SEEMS TO BE GETTING MORE BUCKED. MY DENTIST WANTS TO KNOW IF THERE IS ANY THING BYTE CAN DO TO CORRECT THIS? ATTACHED IS THE LETTER YOU REQUESTED. PLEASE GET BACK TO ME ASAP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556557 BYTE NIGHT ALIGNERS ALIGNER, SEQUENTIAL NXC STRAIGHT SMILE, LLC NBYTE NA 00850017524170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown