BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M¿ CLARITY¿ ADVANCED CERAMIC BRACKETS, APC¿ FLASH-FREE

    MDR report key: 21588949 · Received March 12, 2025

    Report

    Report Number
    2020467-2025-00002
    Event Type
    Injury
    Date Received
    March 12, 2025
    Date of Event
    January 7, 2025
    Report Date
    March 12, 2025
    Manufacturer
    3M UNITEK CORPORATION
    Product Code
    NJM
    PMA / PMN Number
    K102803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MDR 2020467-2025-00002 SUBMITTED ON 12-MAR-2025 NOTED THE FOLLOWING: SECTION B2 OUTCOMES ATTRIBUTED TO ADVERSE EVENT: BLANK. SECTION B5 DESCRIBE EVENT OR PROBLEM: PHYSICIAN REPORTED¿ CORRECTIONS: SECTION B2 OUTCOMES ATTRIBUTED TO ADVERSE EVENT: REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE(DEVICES). SECTION B5 DESCRIBE EVENT OR PROBLEM: AN ORTHODONTIST REPORTED¿

    Additional Manufacturer Narrative · 0

    NO SAMPLE WAS RETURNED FOR ANALYSIS AND NO LOT NUMBER WAS PROVIDED; THEREFORE, CAUSE AND TIMING OF THE ATTRITION COULD NOT BE DETERMINED. SOLVENTUM WILL CONTINUE TO MONITOR.

    Description of Event or Problem · 0

    AN ORTHODONTIST REPORTED THE PATIENT ALLEGEDLY HAD ATTRITION ON THE UPPER TEETH THAT WERE HITTING THE LOWER 3M¿ CLARITY¿ ADVANCED CERAMIC BRACKETS. THE ATTRITION OCCURRED ON THE UPPER CENTRAL AND LATERAL INCISORS. RESTORATIONS WERE REQUIRED FOR 4 TEETH TO REPAIR THE ATTRITION AND RESTORE TEETH TO ORIGINAL STATE.

    Description of Event or Problem · 0

    PHYSICIAN REPORTED THE PATIENT ALLEGEDLY HAD ATTRITION ON THE UPPER TEETH THAT WERE HITTING THE LOWER 3M CLARITY ADVANCED CERAMIC BRACKETS. THE ATTRITION OCCURRED ON THE UPPER CENTRAL AND LATERAL INCISORS. RESTORATIONS WERE REQUIRED FOR 4 TEETH TO REPAIR THE ATTRITION AND RESTORE TEETH TO ORIGINAL STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1689861 3M¿ CLARITY¿ ADVANCED CERAMIC BRACKETS, APC¿ FLASH-FREE BRACKET, CERAMIC, ORTHODONTIC; ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN NJM 3M UNITEK CORPORATION 4006-350 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention