BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BYTE DAY ALIGNERS

    MDR report key: 20582253 · Received October 31, 2024

    Report

    Report Number
    3014845255-2023-01492
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Report Date
    October 31, 2024
    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

    K180346.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT DURING USE OF DAY ALIGNERS, THE SHARP EDGES WERE CAUSING PAIN IN THE MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2067344 BYTE DAY ALIGNERS ALIGNER, SEQUENTIAL NXC STRAIGHT SMILE, LLC HBYTE TRAY NA 00850017524163

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown