BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BYTE NIGHT ALIGNER

    MDR report key: 20053911 · Received August 23, 2024

    Report

    Report Number
    3014845255-2024-00841
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Report Date
    October 7, 2025
    Manufacturer
    STRAIGHT SMILE , LLC
    Product Code
    NXC
    UDI-DI
    00850017524170
    PMA / PMN Number
    K230199
    Product Problem
    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 A BYTE NIGHT ALIGNERS, PATIENT REPORTED THAT THEIR BOTTOM ALIGNER ARE CUTTING INTO THEIR GUMS. THEY ALSO HAVE CAUSED WHITE DISCOLORATION TO THEIR GUMS AND DISCOMFORT. PATIENT HAS TRIED THE WARM WATER TRICK THAT DID NOT WORK. THEY ARE EXPERIENCING BLEEDING AND MORE PAIN. PATIENT ADVISED THE WARM WATER TIP AND TRICKS AS WELL AS SALT WATER RINSES. ASKED FOR UPDATED PHOTOS AND COMFORT LEVEL. PATIENT RESPONDED BACK THAT THE TIPS AND TRICKS DID NOT HELP AND THEY ARE NOT ABLE TO SUCCESSFULLY WEAR THEIR ALIGNERS WITHOUT CAUSING THEIR GUMS TO BE CUT AND BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1582318 BYTE NIGHT ALIGNER ALIGNER, SEQUENTIAL NXC STRAIGHT SMILE , LLC 00850017524170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention