BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M UNITEK APC II GEMINI SL SELF-LIGATING BRACKET

    MDR report key: 7106464 · Received December 11, 2017

    Report

    Report Number
    2020467-2017-00005
    Event Type
    Injury
    Date Received
    December 11, 2017
    Date of Event
    November 13, 2017
    Report Date
    December 11, 2017
    Manufacturer
    3M UNITEK CORPORAION
    Product Code
    DYH
    UDI-DI
    00652221226273
    PMA / PMN Number
    K911271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 3M UNITEK INSTRUCTIONS FOR USE STATE TO INSTRUCT THE PATIENTS NOT TO CHEW OR BITE ON HARD SUBSTANCES SUCH AS HARD CANDY, ICE, CARROTS, ETC. CAREFUL AND THOROUGH PATIENT INSTRUCTION IS KEY TO AVOIDING APPLIANCE OR ENAMEL DAMAGE.

    Description of Event or Problem · 1

    ON (B)(6) 2017, 3M WAS NOTIFIED BY AN ORTHODONTIST THAT A PATIENT BROUGHT A 3M UNITEK APC II GEMINI SL BRACKET (LL5) TO THE OFFICE WHICH DEBONDED FROM TOOTH #20 WITH A PIECE OF TOOTH ENAMEL ATTACHED. THIS BRACKET WAS THE SECOND BRACKET THAT HAD BEEN BONDED TO THE SAME TOOTH; THE PREVIOUS BRACKET HAD BEEN BONDED ON (B)(6) 2017, AND THE CURRENT BRACKET WAS BONDED (B)(6) 2017. A NON-3M BRAND PRIMER WAS USED DURING THE BONDING PROCEDURE. UPON FOLLOW-UP BY 3M, IT WAS LEARNED THAT THE ENAMEL DAMAGE WAS DOWN TO DENTIN. THE PATIENT ADMITTED TO EATING HALLOWEEN CANDY WHEN THE BRACKET CAME OFF. THE ORTHODONTIST APPLIED COMPOSITE TO FILL IN THE AFFECTED AREA OF ENAMEL AND RE-BONDED A NON-3M BRAND BRACKET. THE ORTHODONTIST PLANS TO SEND THE PATIENT TO THEIR DENTIST FOR A PERMANENT RESTORATION AT THE END OF ORTHODONTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885676 3M UNITEK APC II GEMINI SL SELF-LIGATING BRACKET ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN DYH 3M UNITEK CORPORAION 00652221226273

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention