BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BYTE ALIGNERS

    MDR report key: 21410036 · Received February 18, 2025

    Report

    Report Number
    MW5166376
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    January 1, 2023
    Report Date
    February 12, 2025
    Manufacturer
    STRAIGHT SMILE LLC
    Product Code
    NXC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I ORDERED BYTE ALIGNERS IN 2023. THIS COMPANY IS "STRAIGHT SMILE LLC D/B/A BYTE". I RECEIVED A LETTER ABOUT SAFETY NOTIFICATION AND WANTED TO REPORT. I REPORTED ISSUES WITH THE ALIGNERS IN 2023 AND I WAS TOLD I COULD NOT HAVE A REFUND. THAT WAS $(B)(6) FOR ALIGNERS. THEY WERE PAINFUL AND DID NOT MOVE MY TEETH WHATSOEVER. THEY LEFT MY TEETH WITH DECAY FROM WEARING THEM AND I HAD TO GET MULTIPLE CAVITIES AND ROOT CANALS. THE PRODUCT DID NOT HELP MY TEETH MOVE CORRECTLY AND I WAS LEFT WITH 24 ALIGNERS THAT DID NOT FIT MY TEETH CORRECTLY. CUSTOMER SERVICE STOPPED HELPING AND JUST KEPT SAYING THERE IS NO REFUND. AND NOW I AM RECEIVING A SAFETY NOTIFICATION FOR SOMETHING I COMPLAINED ABOUT 2 YEARS AGO. HOW WILL I GET REIMBURSED FOR THE DENTAL VISITS AND THE PRODUCT ITSELF? MY FRONT TOOTH MOVED BACKWARD SO FAR THAT IT MAY NEED TO BE REPLACED WITH A FAKE TOOTH. REFERENCE REPORTS: MW5166367, MW5166368, MW5166369, MW5166370, MW5166371, MW5166372, MW5166373, MW5166374, MW5166375, MW5166377, MW5166378, MW5166379, MW5166380, MW5166381, MW5166382, MW5166383, MW5166384, MW5166385, MW5166386, MW5166387, MW5166388, MW5166389, MW5166390.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2523165 BYTE ALIGNERS ALIGNER, SEQUENTIAL NXC STRAIGHT SMILE LLC 00850017524163

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Other IRON