BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BYTE NIGHT ALIGNERS

    MDR report key: 20768411 · Received November 24, 2024

    Report

    Report Number
    3014845255-2023-01342
    Event Type
    Injury
    Date Received
    November 24, 2024
    Report Date
    November 23, 2024
    Manufacturer
    STRAIGHT SMILE, LLC
    Product Code
    NXC
    UDI-DI
    00850017524170
    PMA / PMN Number
    K180346
    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 21 CFR 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.

    Description of Event or Problem · 0

    THE PATIENT STATED: "RECENTLY RECEIVED TREATMENT BUT IS UNABLE TO CONTINUE DUE TO AN ABSCESS THAT FORMED IN HER UPPER ARCH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1852558 BYTE NIGHT ALIGNERS ALIGNER, SEQUENTIAL NXC STRAIGHT SMILE, LLC NBYTE TRAY NA 00850017524170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown