BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M UNITEK APC II¿ CLARITY¿ ADVANCED MBT CERAMIC BRACKET

    MDR report key: 7631089 · Received June 22, 2018

    Report

    Report Number
    2020467-2018-00003
    Event Type
    Injury
    Date Received
    June 22, 2018
    Date of Event
    May 31, 2018
    Report Date
    June 22, 2018
    Manufacturer
    3M UNITEK CORPORATION
    Product Code
    NJM
    UDI-DI
    00652221162717
    PMA / PMN Number
    K102803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT MAY BE RELATED TO THE PREVIOUSLY COMPROMISED RESTORATION OF THE TOOTH. SINCE THIS EVENT INVOLVED TWO MEDICAL DEVICES, TWO MANUFACTURER REPORTS ARE BEING SUBMITTED. THIS REPORT (2020467-2018-00003) REPRESENTS THE FIRST MEDICAL DEVICE, AND 2020467-2018-00004 REPRESENTS THE SECOND DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2018, 3M WAS NOTIFIED THAT A FEMALE PATIENT, APPROXIMATELY (B)(6), HAD A LARGE BUCCAL FILLING BREAK OFF FROM A PREVIOUSLY RESTORED UPPER PRE-MOLAR TOOTH UPON DEBONDING OF A 3M APC II CLARITY ADVANCED CERAMIC BRACKET. THE BREAK WAS REPORTED TO BE DOWN TO DENTIN. THE BRACKET HAD BEEN IN PLACE FOR APPROXIMATELY 18 MONTHS. THE ORTHODONTIST REPORTED THAT THE LARGE FILLING/RESTORATION ON THE TOOTH DID NOT LOOK NORMAL. OTHER PRODUCTS USED WHEN THE BRACKET WAS INITIALLY BONDED INCLUDED A NON-3M BRAND ETCHANT. IN ADDITION, ALTHOUGH THE BRAND OF THE PRIMER OR CATALOG NUMBER WAS NOT DISCLOSED BY THE REPORTING FACILITY, BASED UPON A DESCRIPTION OF THE PRODUCT AND SALES HISTORY, IT IS SUSPECTED THAT 3M TRANSBOND PLUS SELF ETCHING PRIMER WAS ALSO POTENTIALLY USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471071 3M UNITEK APC II¿ CLARITY¿ ADVANCED MBT CERAMIC BRACKET BRACKET, CERAMIC, ORTHODONTIC NJM 3M UNITEK CORPORATION 00652221162717

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention