BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAR DENTAL ALIGNERS

    MDR report key: 20736468 · Received November 19, 2024

    Report

    Report Number
    MW5162720
    Event Type
    Injury
    Date Received
    November 19, 2024
    Date of Event
    November 17, 2024
    Report Date
    November 17, 2024
    Manufacturer
    BYTE/STRAIGHT SMILE, LLC
    Product Code
    NXC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I AM REQUESTING A REVIEW OF MY TREATMENT DUE TO THE FACT THAT BYTE HAS FAILED TO SEND THE CONTINUATION TREATMENT AND HAS SENT ME RETAINERS. I AM COMPLETELY DISSATISFIED WITH MY TREATMENT AND CARE. I AM UNABLE TO WEAR THE RETAINERS SENT TO ME. THE TOP IS AS IF IT WAS MADE FOR SOMEONE ELSE AND I HAVEN'T COMPLETED THE BOTTOM ARCH TREATMENT, SO THE RETAINER CANNOT POSSIBLY FIT. IT HAS BEEN A FEW MONTHS NOW AND I BELIEVE I AM NOT ABLE TO EVEN RESTART OR CONTINUE MOVING MY TEETH AS THIS CAN BE DANGEROUS TO MY ORAL HEALTH. I AM IN DANGER OF HAVING MY TEETH BEGIN TO MOVE FROM THE NEW POSITION AS THE UPPER RETAINER I AM WEARING NOW IS CRACKED AND I AM STILL WEARING THE LAST ALIGNER I RECEIVED FOR MY BOTTOM ARCH. BYTE IS REFUSING TO ASSIST ME UNLESS I SIGN A NEW AGREEMENT WITH THEM AND PAY FOR ANOTHER DENTAL VISIT FROM MY DOCTOR. THEY ARE IN BREACH OF MY ORIGINAL CONTRACT, THEY HAVE A TOTAL DISREGARD FOR THE HEALTH AND SAFETY OF MY TEETH AND ORAL HEALTH BY STOPPING MY CARE BEFORE COMPLETION. THIS IS UNACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1972108 CLEAR DENTAL ALIGNERS ALIGNER, SEQUENTIAL NXC BYTE/STRAIGHT SMILE, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention VITAMIN D AND B COMPLEX.