BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BYTE NIGHT ALIGNERS

    MDR report key: 20619848 · Received November 6, 2024

    Report

    Report Number
    3014845255-2024-02430
    Event Type
    Malfunction
    Date Received
    November 6, 2024
    Report Date
    October 10, 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

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803.

    Additional Manufacturer Narrative · 0

    A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    Description of Event or Problem · 0

    PATIENT REPORTS STARTED WEARING THE ALIGNERS TWO DAYS AGO AND TOP RIGHT SIDE IS CUTTING/RUBBING INTO THE GUMS AND CAUSING INFLAMMATION/PAIN/DISCOMFORT. PATIENT INDICATED THE ALIGNERS ARE TIGHT BUT TOLERABLE. HOWEVER, THE ALIGNER IS GOING INTO THE GUMS AND BLANCHING CAN BE SEEN ON THE LOWER, BUT THE FIT APPEARS TO BE WNL (WITHIN NORMAL LIMITS). DENTAL HISTORY INCLUDES CROWNS AT 16, 1, GRINDS/CLENCHES TEETH, USES NIGHTGUARD/SLEEP APNEA DEVICE AND SCALING OR ROOT PLANNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1460124 BYTE NIGHT ALIGNERS ALIGNER, SEQUENTIAL NXC STRAIGHT SMILE, LLC NBYTE TRAY 00850017524170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown