BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BYTE NIGHT ALIGNERS

    MDR report key: 21223493 · Received January 23, 2025

    Report

    Report Number
    3014845255-2024-03858
    Event Type
    Malfunction
    Date Received
    January 23, 2025
    Report Date
    November 4, 2025
    Manufacturer
    STRAIGHT SMILE, LLC
    Product Code
    NXC
    UDI-DI
    00850017524170
    PMA / PMN Number
    K180346
    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 21 CFR PART 803.

    Additional Manufacturer Narrative · 0

    A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    Description of Event or Problem · 0

    A PATIENT REPORTED UPPER ALIGNER CAUSING PAIN AND AIR GAPS NOT WITHIN NORMAL LIMITS. HOWEVER, THE PATIENT STATED THAT IT IS NOT THE PROBLEM, THE PROBLEM IS THE ALIGNERS ARE CUTTING INTO THEIR GUMS, AND THE PATIENT IS SEEING BLOOD IN THEIR ALIGNERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440223 BYTE NIGHT ALIGNERS ALIGNER, SEQUENTIAL NXC STRAIGHT SMILE, LLC NBYTE NA 00850017524170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other