APC FLASH-FREE VICTORY SERIES SUPERIOR FIT BUCCAL TUBE
Received Nov 22, 2017 · Event occurred Sep 27, 2017
Report 2020467-2017-00003 · MDR key 7054445
Device
Generic name
Adhesive, Bracket And Tooth Conditioner, Resin
Manufacturer
3m Unitek CorporaionCatalog number
4069-5114
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
SINCE TWO 3M UNITEK PRODUCTS WERE INVOLVED IN THIS EVENT, TWO MANUFACTURER REPORTS ARE BEING FILED. THE CURRENT MANUFACTURER REPORT IS RELATED TO THE FIRST DEVICE AND MANUFACTURER REPORT 2020467-2017-00004 IS RELATED TO THE SECOND DEVICE.
Description of Event or Problem
ON (B)(6) 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.