BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BYTE NIGHT ALIGNERS

    MDR report key: 20746533 · Received November 21, 2024

    Report

    Report Number
    3014845255-2024-02690
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Report Date
    November 29, 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 THE ALIGNERS ARE VERY TIGHT, PAINFUL, GOT A BRUISE AND A BLISTER ON THE INNER FRONT LIP. THE PATIENT FILED THE ALIGNER DOWN AND SOFTENED IT IN HOT WATER AND IT STILL HURT. THE ALIGNER IS HITTING THE CANINE TEETH AND THERE'S A GAP ON THE OTHER TEETH. THE CST (CLINICAL SUPPORT TEAM) NOTED IN THE RECORD THAT THE LOWER ALIGNERS DO NOT FIT WNL (WITHIN NORMAL LIMITS). DENTAL HISTORY INCLUDES ORTHODONTIC BRACES, CROWNS AT LOCATIONS: 15, 18, GRINDING/CLENCHING OF TEETH, PREVIOUS ROOT CANAL TREATMENT, USE OF NIGHTGUARD/SLEEP APNEA DEVICE, ACTIVE PERIODONTAL DISEASE, SCALING OR ROOT PLANNING AND NO BRACES OR ATTACHMENTS. MEDICAL HISTORY INCLUDES PAIN ON TEETH WITH CROWNS. MEDICATIONS INCLUDE LIPATOR, ATENOLOL, UNITHROID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2013736 BYTE NIGHT ALIGNERS ALIGNER, SEQUENTIAL NXC STRAIGHT SMILE, LLC NBYTE TRAY 00850017524170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown