BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSBOND PLUS SELF-ETCHING PRIMER

    MDR report key: 7054444 · Received November 22, 2017

    Report

    Report Number
    2020467-2017-00004
    Event Type
    Injury
    Date Received
    November 22, 2017
    Date of Event
    September 27, 2017
    Report Date
    November 22, 2017
    Manufacturer
    3M UNITEK CORPORAION
    Product Code
    KLE
    UDI-DI
    00652221109170
    PMA / PMN Number
    K001494
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE TWO 3M UNITEK PRODUCTS WERE INVOLVED IN THIS EVENT, TWO MANUFACTURER REPORTS ARE BEING FILED. THE CURRENT MANUFACTURER REPORT IS RELATED TO THE SECOND DEVICE AND MANUFACTURER REPORT 2020467-2017-00003 IS RELATED TO THE FIRST DEVICE.

    Description of Event or Problem · 1

    ON OCTOBER 27, 2017, 3M WAS NOTIFIED BY AN ORTHODONTIST THAT THE TOP LAYER OF ENAMEL BROKE OFF A (B)(6) MALE PATIENT'S TOOTH (#3) UPON DEBONDING OF A 3M UNITEK APC FLASH FREE VICTORY SERIES FIT BUCCAL TUBE. 3M UNITEK TRANSBOND PLUS SELF-ETCHING PRIMER WAS USED TO PLACE THE BRACKET. THE ORTHODONTIST SENT THE PATIENT TO THEIR DENTIST TO HAVE THE TOOTH REPAIRED. UPON FOLLOW-UP BY 3M WITH THE ORTHODONTIST, IT WAS LEARNED THAT THE ENAMEL DAMAGE WAS DOWN TO DENTIN AND THE ORTHODONTIST REPORTED THAT THE TOOTH APPEARED TO BE NORMAL PRIOR TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831638 TRANSBOND PLUS SELF-ETCHING PRIMER AGENT,TOOTH BONDING RESIN KLE 3M UNITEK CORPORAION 00652221109170

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention