3M UNITEK APC II GEMINI SL SELF-LIGATING BRACKET

Additional Manufacturer Narrative

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

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

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.