BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BYTE DAY ALIGNERS

    MDR report key: 20323617 · Received September 27, 2024

    Report

    Report Number
    3014845255-2021-00313
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Report Date
    December 16, 2025
    Manufacturer
    STRAIGHT SMILE, LLC
    Product Code
    NXC
    UDI-DI
    00850017524163
    PMA / PMN Number
    K180346
    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. 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

    PATIENT REPORTED ALIGNERS ARE CUTTING THEIR LIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1491396 BYTE DAY ALIGNERS ALIGNER, SEQUENTIAL NXC STRAIGHT SMILE, LLC HBYTE TRAY 00850017524163

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown