BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M¿ SMARTCLIP¿ SL3 SELF-LIGATING BRACKETS

    MDR report key: 23343926 · Received October 20, 2025

    Report

    Report Number
    2020467-2025-00004
    Event Type
    Injury
    Date Received
    October 20, 2025
    Date of Event
    September 18, 2025
    Report Date
    October 20, 2025
    Manufacturer
    3M UNITEK CORPORATION
    Product Code
    EJF
    UDI-DI
    00652212259481
    PMA / PMN Number
    K113197
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS NOT RETURNED FOR ANALYSIS. A LOT NUMBER WAS PROVIDED. THE COMPLAINT HISTORY WAS REVIEWED AND THERE ARE NO ADVERSE TRENDS. THE INSTRUCTIONS FOR USE (IFU) CONTAINS STATEMENTS THAT ACRYLATE MONOMERS ARE KNOWN TO PRODUCE ALLERGIC SKIN REACTIONS IN CERTAIN SENSITIVE INDIVIDUALS AND MAY CAUSE EYE AND SKIN IRRITATION, AND ALSO FOR NICKEL AND/OR CHROMIUM, WHERE A SMALL PERCENTAGE OF THE POPULATION IS KNOWN TO BE ALLERGIC TO NICKEL AND/OR CHROMIUM. SOLVENTUM WILL CONTINUE TO MONITOR.

    Description of Event or Problem · 0

    A SEVERE ALLERGIC REACTION WAS ALLEGED WHERE A PATIENT EXPERIENCED SWOLLEN LIPS AND BREATHING ISSUES. MEDICAL TREATMENT WITH CORTICOSTEROIDS WERE GIVEN. THE PATIENT HAS A KNOWN ALLERGY AGAINST SILICONE THAT WAS NOT KNOWN BY THE ORTHODONTIST PRIOR TO ORTHODONTIC TREATMENT. THE SYMPTOMS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2452571 3M¿ SMARTCLIP¿ SL3 SELF-LIGATING BRACKETS BRACKET, METAL, ORTHODONTIC; ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN EJF 3M UNITEK CORPORATION 4004-122 RV4NV 00652212259481

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention