BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BYTE DAY ALIGNERS

    MDR report key: 20614805 · Received November 5, 2024

    Report

    Report Number
    3014845255-2024-02022
    Event Type
    Malfunction
    Date Received
    November 5, 2024
    Report Date
    December 9, 2025
    Manufacturer
    STRAIGHT SMILE, LLC
    Product Code
    NXC
    UDI-DI
    00850017524163
    PMA / PMN Number
    K230199
    Adverse Event
    Yes
    Product Problem
    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

    CORRECTIONS: B1, B2, B5, D1, D2, D2A, D2B, D3, D4, E1, E2, E3, E4, G1, G2, G3, G4, G8, H1, H3, H5, H6, H8, H11 (MANUFACTURER NARRATIVE) NOTE: AN INCORRECT INITIAL 3500A SUBMISSION WAS INADVERDANTLY SUBMITTED FOR THIS MFR REPORT #. ALL PREVIOUSLY SUBMITTED INFORMATION WILL BE CORRECTED BY THE DATA PROVIDED IN THIS FOLLOW UP. 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

    CUSTOMER REPORTED THAT THEY HAD A DENTAL EVALUATION: UPPER ARCH MODERATE CROWDING; LOWER ARCH MILD CROWDING; PATIENT HAS CLASS II MALOCCLUSION; CLENCHING AND GRINDING. RECOMMENDED TREATMENT: WE RECOMMENDED COMPREHENSIVE ORTHODONTIC TREATMENT WITH INVISALIGN. NO ADDITIONAL INFORMATION WAS REPORTED.

    Description of Event or Problem · 0

    THE PATIENT REPORTED: THIS SET OF ALIGNERS ISN'T FITTING CORRECTLY OVER MY MOLARS, SO THEY ARE DIGGING INTO MY CHEEK AND TONGUE. (B)(6) 2024: THE ALIGNERS HAVE CUT INTO MY MOLARS. I HAD MY BROKEN FILLING FIXED, AS I MENTIONED WHEN I SIGNED UP, BUT THE ALIGNERS WERE MADE TO FIT THE BROKEN FILLING INSTEAD OF THE FIXED ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1992136 BYTE DAY ALIGNERS ALIGNER, SEQUENTIAL NXC STRAIGHT SMILE, LLC HBYTE TRAY NA 00850017524163

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown