3M UNITEK APC II GEMINI SL SELF-LIGATING BRACKET
Received Dec 11, 2017 · Event occurred Nov 13, 2017
Report 2020467-2017-00005 · MDR key 7106464
Device
Generic name
Adhesive, Bracket And Tooth Conditioner, Resin
Manufacturer
3m Unitek CorporaionCatalog number
3027-382
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
13 YR
- Tooth Fracture
- Tooth Fracture
Narrative
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)(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.