BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BYTE DAY ALIGNERS

    MDR report key: 22301491 · Received June 20, 2025

    Report

    Report Number
    3031789024-2025-02962
    Event Type
    Injury
    Date Received
    June 20, 2025
    Report Date
    November 14, 2025
    Manufacturer
    STRAIGHT SMILE LLC
    Product Code
    NXC
    UDI-DI
    00850017524163
    PMA / PMN Number
    K230199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE PROBLEM CODE ADDED-UNINTENDED MOVEMENT.

    Additional Manufacturer Narrative · 0

    A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    Description of Event or Problem · 0

    PATIENT REPORTED THEIR TEETH CANNOT CLENCH TOGETHER; THEY DO NOT TOUCH. THEY HAVE AN OPEN BITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1807196 BYTE DAY ALIGNERS ALIGNER, SEQUENTIAL NXC STRAIGHT SMILE LLC MD3171JCRF 00850017524163

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention