BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BYTE DAY ALIGNERS

    MDR report key: 21236190 · Received January 25, 2025

    Report

    Report Number
    3014845255-2024-03949
    Event Type
    Injury
    Date Received
    January 25, 2025
    Report Date
    October 30, 2025
    Manufacturer
    STRAIGHT SMILE, LLC
    Product Code
    NXC
    UDI-DI
    00850017524163
    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

    "PERIODONTITIS: TRUE " I WAS TOLD THAT I NEEDED TO FIND OUT ABOUT TREATMENT FOR MY RECEDING GUM LINE BEFORE GETTING BOTTOM LINERS. MY DENTIST TOLD ME MY ONLY OPTIONS WOULD BE TO GET A CLEANING AND THEN POTENTIALLY ONE DAY A GUM GRAFT. I PAID GOOD MONEY FOR THESE ALIGNERS. I AM UNABLE TO GET A GUM GRAFT. I WANT MY BOTTOM TEETH TREATED. I WOULD NOT HAVE PAID FOR THESE LINERS IF I KNEW THIS WOULD BE THE CASE. I WOULD HAVE JUST WENT TO A REGULAR ORTHODONTIST. I'M EXTREMELY FRUSTRATED AND ANNOYED THAT I CONTINUE TO TRY TO REACH OUT AND GET NOTHING. MY TREATMENT PLAN GETS "UPDATED" AND IT'S THE SAME THING. UNCHANGED." EMAIL FROM CASE #(B)(4) 8/13/2024"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2376972 BYTE DAY ALIGNERS ALIGNER, SEQUENTIAL NXC STRAIGHT SMILE, LLC HBYTE TRAY NA 00850017524163

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown