BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMILESET

    MDR report key: 25113823 · Received May 7, 2026

    Report

    Report Number
    3032193293-2026-00001
    Event Type
    Injury
    Date Received
    May 7, 2026
    Date of Event
    April 7, 2026
    Report Date
    May 7, 2026
    Manufacturer
    ORTHO DENTAL LAB, LLC
    Product Code
    NXC
    PMA / PMN Number
    K212496
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES THE FACT THAT THE SMILESET ALL-DAY ALIGNERS CAUSED OR CONTRIBUTED TO THE PATIENTS SYMPTOMS. THIS EVENT IS BEING FILED AS A MDR AS THE PATIENT REPORTED A BROKEN TOOTH WHILE A SMILESET ALL-DAY ALIGNER WAS BEING USED.

    Description of Event or Problem · 0

    CUSTOMER ALLEGED THAT THE ALIGNERS DID NOT FIT THEIR TEETH PROPERLY AND ALLEGEDLY CAUSED ONE OF THEIR TEETH TO BREAK. CUSTOMER STATED THEY ARE NOW GOING TO HAVE AN IMPLANT PLACED AND REQUESTED TO RETURN THE ALIGNERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533932 SMILESET SMILESET ALL-DAY ALIGNERS NXC ORTHO DENTAL LAB, LLC 121-0106

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Required Intervention