BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BYTE ALIGNER SYSTEM

    MDR report key: 21918710 · Received April 28, 2025

    Report

    Report Number
    MW5169548
    Event Type
    Injury
    Date Received
    April 28, 2025
    Report Date
    April 25, 2025
    Manufacturer
    STRAIGHT SMILE, LLC
    Product Code
    NXC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS DIAGNOSED WITH A TMJ DISORDER AFTER WEARING THE BYTE ALIGNERS SINCE (B)(6) 2023. HER CHIROPRACTOR AND DENTIST CONFIRMED THE INJURY. SHE NOTICED A DIFFERENCE IN HER JAW AFTER ONLY A FEW DAYS OF WEARING THE DEVICE. SHE SWITCHED THE DEVICE AND FOUND THE NEW DEVICE TO HAVE THE SAME ISSUE. AFTER A FEW WEEKS, SHE STARTED TO GET BAD MIGRAINES, JAW ACHES, & EPISODES OF LIGHTHEADEDNESS. HER JAW SHIFTED SIDEWAYS AS A RESULT. SHE IS CURRENTLY USING INVISALIGN TO CORRECT THE PROBLEM THE BYTE ALIGNERS MADE. SHE CONTACTED STRAIGHT SMILES LLC WHO WANTED HER TO SIGN A WAIVER TO SUE TO BEGIN THE CONVERSATION REGARDING REIMBURSEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480867 BYTE ALIGNER SYSTEM ALIGNER, SEQUENTIAL NXC STRAIGHT SMILE, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female Required Intervention