BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M UNITEK APC II GEMINI SL SELF-LIGATING BRACKET

    MDR report key: 7106467 · Received December 11, 2017

    Report

    Report Number
    2020467-2017-00006
    Event Type
    Injury
    Date Received
    December 11, 2017
    Date of Event
    November 27, 2017
    Report Date
    January 31, 2018
    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

    PER VISUAL EXAM OF THE RETURNED BRACKET, THERE IS NOTHING UNUSUAL WITH THE METAL BRACKET OR THE SHAPE OF THE BONDING BASE; HOWEVER, A THICK ADHESIVE LAYER WITH FLASH WAS STILL PRESENT AND WRAPPED ONTO THE TOP SIDE OF THE BONDING BASE. THE MESH SIDE OF THE BONDING BASE WAS NOT VISIBLE DUE TO THE ADHESIVE AND ENAMEL STILL ATTACHED. THE 3M UNITEK INSTRUCTIONS FOR USE FOR APC II ADHESIVE, FOR BRACKET PLACEMENT, INDICATES "GENTLY REMOVE EXCESS ADHESIVE AROUND APPLIANCE BASE WITHOUT DISTURBING THE APPLIANCE." BASED UPON THE VISUAL EVALUATION OF THE RETURNED BRACKET, IT APPEARS THAT THE EXCESS ADHESIVE MAY NOT HAVE BEEN REMOVED UPON BRACKET PLACEMENT, WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. IN ADDITION, IT CANNOT BE ASCERTAINED IF THE USE OF NON-3M BRAND PRIMER MAY HAVE CONTRIBUTED TO THIS EVENT.

    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)(4) 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 THIRD BRACKET THAT HAD BEEN BONDED TO THE SAME TOOTH; THE PREVIOUS BRACKETS HAD BEEN BONDED ON (B)(6) 2016 AND (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 HARD PIZZA CRUST WHEN THE LL5 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
    885677 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 15 YR Required Intervention