BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BYTE NIGHT ALIGNERS

    MDR report key: 23131784 · Received September 24, 2025

    Report

    Report Number
    3031789024-2025-03629
    Event Type
    Injury
    Date Received
    September 24, 2025
    Report Date
    November 3, 2025
    Manufacturer
    STRAIGHT SMILE LLC
    Product Code
    NXC
    PMA / PMN Number
    K230199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    Additional Manufacturer Narrative · 0

    SINCE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21 CFR PART 803.

    Description of Event or Problem · 0

    PATIENT REPORTED THEY PROVIDED A LETTER OF RECOMMENDATION FROM THEIR DENTIST. IN THE LETTER THE DENTIST STATES THAT THE PATIENT WAS EVALUATED IN THE OFFICE AND FOUND PATIENT TO HAVE CROWDING AND A CLASS II MALOCCLUSION RESULTING IN A SIGNIFICANT OVERJET IN THE ANTERIOR TEETH. DENTIST RECOMMENDED PATIENT TO CEASE BYTE ALIGNER TREATMENT. CEASING TREATMENT DUE TO THE PATIENT'S SIGNIFICANT OVERJET, MALOCCLUSION AND THE POTENTIAL SURGERY TO PROPERLY CORRECT THESE ISSUES. PATIENT IS RECOMMENDED TO BE EVALUATED IN PERSON BY AN ORTHODONTIST IN ORDER TO RECEIVE THE APPROPRIATE RADIOGRAPHS AND IMAGING TO DETERMINE IF ORTHOGNATHIC SURGERY IS NECESSARY TO CORRECT THESE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1598502 BYTE NIGHT ALIGNERS ALIGNER, SEQUENTIAL NXC STRAIGHT SMILE LLC MN3915PDSD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention