BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BYTE NIGHT ALIGNERS

    MDR report key: 20577722 · Received October 31, 2024

    Report

    Report Number
    3014845255-2024-02347
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Report Date
    October 12, 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 REPORTED THE ALIGNERS CUTTING INTO THEIR CHEEKS CAUSING PAIN. THEIR GUMS BELOW THEIR TWO BOTTOM TEETH ARE SUPER SENSITIVE AND TENDER TO THE TOUCH. PROVIDED INFORMATION ON GUM DISCOMFORT, RECOMMENDED FILING TIPS FOR CUTTING AND ADVISED A 14 DAY IN WEAR FOR COMFORTABLE LOWER ALIGNER. CURRENT ALIGNERS FIT ARE WITH IN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2011342 BYTE NIGHT ALIGNERS ALIGNER, SEQUENTIAL NXC STRAIGHT SMILE, LLC NBYTE TRAY 00850017524170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown