BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BYTE ALIGNERS

    MDR report key: 25047383 · Received April 30, 2026

    Report

    Report Number
    MW5187520
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    April 28, 2026
    Report Date
    April 28, 2026
    Manufacturer
    DENTSPLY SIRONA INC
    Product Code
    NXC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    003
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I AM REPORTING PATIENT ABANDONMENT AND LACK OF CLINICAL OVERSIGHT FOLLOWING THE ISSUANCE OF A FIELD SAFETY NOTICE. DESPITE ONGOING TREATMENT WITH A PRESCRIPTION MEDICAL DEVICE (CLEAR ALIGNERS), THE PRESCRIBING PHYSICIAN, (B)(6), AND BYTE SUPPORT HAVE FAILED TO PROVIDE THE MANDATED DENTAL SUPERVISION. I HAVE EXPERIENCED TOOTH MOBILITY, BITE MISALIGNMENT AND CROWDING LEADING TO CHIPPING AND NEED DENTAL WORK. I HAVE REPEATEDLY CONTACTED BYTE SUPPORT TO REPORT THESE ADVERSE EXPERIENCES, BUT MY CONCERNS WERE IGNORED OR NOT ADDRESSED. FOLLOWING THE RECENT FIELD SAFETY NOTICE, THE COMPANY HAS FAILED TO PROVIDE A SAFE CLINICAL EXIT STRATEGY OR A REFUND TO SEEK CORRECTIVE CARE FROM A LOCAL PROVIDER. THE DEVICE LACKS THE PROFESSIONAL MONITORING REQUIRED BY LAW FOR A CLASS II MEDICAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408175 BYTE ALIGNERS ALIGNER, SEQUENTIAL NXC DENTSPLY SIRONA INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R