BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BYTE DAY ALIGNERS

    MDR report key: 20619850 · Received November 6, 2024

    Report

    Report Number
    3014845255-2024-02443
    Event Type
    Malfunction
    Date Received
    November 6, 2024
    Report Date
    October 10, 2025
    Manufacturer
    STRAIGHT SMILE, LLC
    Product Code
    NXC
    UDI-DI
    00850017524163
    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 REPORTED THEIR ALIGNERS CUTTING INTO THEIR GUMS AND THEY ARE SUPER TIGHT ANC CAUSING THEIR GUMS TO TURN WHITE. PATIENT'S UPPER AND LOWER ALIGNER FIT ARE WITH IN NORMAL LIMITS, BLANCHING IS PRESENT. PROVIDED INFORMATION ON BLANCHING DURING TREATMENT AND HH TIPS. REQUESTED UPDATED PHOTOS AFTER TRYING HH TIPS AND IF FIT IS MORE COMFORTABLE. ADVISED TO ALSO TRY NEXT STEP ALIGNERS TO SEE IF THEY ARE MORE COMFORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1460126 BYTE DAY ALIGNERS ALIGNER, SEQUENTIAL NXC STRAIGHT SMILE, LLC HBYTE TRAY 00850017524163

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown