BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BYTE NIGHT ALIGNERS

    MDR report key: 20620870 · Received November 6, 2024

    Report

    Report Number
    3014845255-2024-02025
    Event Type
    Injury
    Date Received
    November 6, 2024
    Report Date
    December 9, 2025
    Manufacturer
    STRAIGHT SMILE, LLC
    Product Code
    NXC
    UDI-DI
    00850017524170
    PMA / PMN Number
    K230199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NOTE: AN INCORRECT INITIAL 3500A SUBMISSION WAS INADVERTENTLY SUBMITTED FOR THIS MFR REPORT #. ALL PREVIOUSLY SUBMITTED INFORMATION WILL BE CORRECTED BY THE DATA PROVIDED IN THIS FOLLOW UP. 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

    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 (B)(6) 2021 THROUGH (B)(6) 2024.

    Additional Manufacturer Narrative · 0

    A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    Description of Event or Problem · 0

    A LETTER OF RECOMMENDATION WAS RECEIVED TO CEASE TREATMENT DUE TO GUM RECESSION.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THEY PROVIDED A LETTER OF RECOMMENDATION TO CEASE TREATMENT DUE TO THE ALIGNERS MAKING IT WORSE. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461190 BYTE NIGHT ALIGNERS ALIGNER, SEQUENTIAL NXC STRAIGHT SMILE, LLC NBYTE TRAY NA 00850017524170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown