BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BYTE NIGHT ALIGNERS

    MDR report key: 20567089 · Received October 30, 2024

    Report

    Report Number
    3014845255-2023-01009
    Event Type
    Injury
    Date Received
    October 30, 2024
    Report Date
    October 25, 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 21CFR PART 803. THIS MDR IS BEING SUBMITTED AS 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

    "ABOUT 7 WEEKS INTO TREATMENT I NOTICED INCREASED SENSITIVITY IN MY BOTTOM LEFT FRONT MOST TOOTH, PARTICULARLY WHEN EXPOSED TO COLD. THIS CONTINUED BUT I WASN'T ESPECIALLY CONCERNED UNTIL HALFWAY THROUGH THE WEEK WHEN I BEGAN NOTICING DISCOLORATION STARTING FROM THE BASE OF THAT TOOTH. I WENT TO THE EMERGENCY DENTIST AND THEY INFORMED ME THAT MY TOOTH WAS LOOSE AND LIKELY BROKEN, WITH POSSIBLE PUP NECROSIS. THE CITED THE ALIGNERS AS THE LIKELY CAUSE OF THIS ISSUE AND ADVISED ME TO DISCONTINUE USE, WHICH I HAVE. I WOULD IKE MY MONEY BACK/REMAINING CARE CREDIT BALANCE VOIDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725286 BYTE NIGHT ALIGNERS ALIGNER, SEQUENTIAL NXC STRAIGHT SMILE, LLC HBYTE TRAY NA 00850017524170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown