BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BYTE DAY ALIGNERS

    MDR report key: 20982603 · Received December 19, 2024

    Report

    Report Number
    3014845255-2024-03135
    Event Type
    Injury
    Date Received
    December 19, 2024
    Report Date
    November 9, 2025
    Manufacturer
    STRAIGHT SMILE, LLC
    Product Code
    NXC
    PMA / PMN Number
    K230199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21CFR PART 803. THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS AND HARMONIZATION MADE TO THE COMPANY'S COMPLAINT HANDLING PROCESSES. THERE IS NO CHANGE TO DEVICE PERFORMANCE OR TO THE DEVICE RISK PROFILE. A CAPA (2023-487) HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING. THIS RETROSPECTIVE REVIEW INCLUDES THE DATE RANGE OF 05/17/2021 THROUGH 05/31/2024.

    Additional Manufacturer Narrative · 0

    A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE RIGHT TOOTH BESIDE THE FRONT RIGHT TOOTH IS STILL SLIGHTLY BEHIND THEIR RIGHT FRONT TOOTH, AND THE BITE IS STILL WEIRD WHEN SMILE WITH TEETH CLOSED, ON THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2511904 BYTE DAY ALIGNERS ALIGNER, SEQUENTIAL NXC STRAIGHT SMILE, LLC HBYTE TRAY NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown