BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M UNITEK APC¿ FLASH-FREE CLARITY¿ ADVANCED MBT

    MDR report key: 7134783 · Received December 20, 2017

    Report

    Report Number
    2020467-2017-00007
    Event Type
    Injury
    Date Received
    December 20, 2017
    Date of Event
    November 21, 2017
    Report Date
    December 19, 2017
    Manufacturer
    3M UNITEK CORPORAION
    Product Code
    NJM
    UDI-DI
    00652221217806
    PMA / PMN Number
    K102803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IFU FOR 3M UNITEK CLARITY ADVANCED CERAMIC BRACKETS DOES CONTAIN A WARNING THAT STATES "INSTRUCT PATIENTS NOT TO CHEW OR BITE ON HARD SUBSTANCES SUCH AS HARD CANDY, ICE, CARROTS, ETC. CAREFUL AND THOROUGH PATIENT INSTRUCTION IS A KEY TO AVOIDING APPLIANCE OR ENAMEL DAMAGE." SINCE THIS EVENT INVOLVED TWO MEDICAL DEVICES, TWO MANUFACTURER REPORTS ARE BEING SUBMITTED. THIS REPORT (2020467-2017-00007) REPRESENTS THE FIRST MEDICAL DEVICE, AND 2020467-2017-00008 REPRESENTS THE SECOND DEVICE.

    Description of Event or Problem · 1

    ON (B)(6), 2017, 3M WAS NOTIFIED THAT A (B)(6) OLD MALE PATIENT HAD A 3M UNITEK APC FLASH-FREE CLARITY ADVANCED UPPER LEFT BICUSPID BRACKET (UL5) DEBOND FROM TOOTH #13 WHILE EATING AN APPLE. THE DEBONDED BRACKET CONTAINED TOOTH ENAMEL. THE ORTHODONTIST REMOVED THE BRACKET THAT WAS STILL ATTACHED TO THE ARCHWIRE AND SENT THE PATIENT TO HIS DENTIST FOR RESTORATION OF THE ENAMEL. UPON 3M FOLLOW-UP WITH THE ORTHODONTIST, ENAMEL DAMAGE DOWN TO DENTIN WAS REPORTED. THE BRACKET WAS INITIALLY PLACED ON (B)(6) 2016. OTHER PRODUCTS USED WHEN THE BRACKET WAS PLACED INCLUDED A NON-3M ETCHANT AND 3M UNITEK TRANSBOND PLUS SELF-ETCHING PRIMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913419 3M UNITEK APC¿ FLASH-FREE CLARITY¿ ADVANCED MBT BRACKET, CERAMIC, ORTHODONTIC NJM 3M UNITEK CORPORAION 00652221217806

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention