APC(TM) FLASH-FREE CLARITY(TM) ADVANCED CERAMIC BRACKET
Received Oct 20, 2016 · Event occurred Sep 22, 2016
Report 2020467-2016-00004 · MDR key 6046138
Device
Generic name
Ceramic Orthodontic Bracket
Manufacturer
3m Unitek CorporationCatalog number
4006-250
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
15 YR
- Tooth Fracture
- Tooth Fracture
Narrative
Additional Manufacturer Narrative
DOCTOR STATES THAT THE TOOTH HAD NO EVIDENCE OF DAMAGE PRIOR TO THE PATIENT'S INITIAL BONDING. THE HYGIENIST WHO PERFORMED THE DEBONDING HAS PERFORMED APPROXIMATELY 1200 DEBONDINGS, AND IS SKILLED AT THE PROCEDURE. 3M UNITEK HAS HAD NO PRIOR INCIDENCES OF A TOOTH BREAKING HORIZONTALLY UPON DEBONDING. IT IS POSSIBLE THAT THE PATIENT EXPERIENCED A BLOW TO THE MOUTH THAT FRACTURED THE TOOTH, BUT IT WAS KEPT INTACT BY THE BRACKET AND THEN BROKE UPON DEBONDING. THE ORTHODONTIST BELIEVES THAT THIS INCIDENT IS AN ANOMALY, AND IS UNSURE OF THE CAUSE.
Description of Event or Problem
PATIENT WAS AT ORTHODONTIST TO HAVE BRACES REMOVED AT END OF TREATMENT. UPON DEBONDING THE LOWER RIGHT CENTRAL ANTERIOR BRACKET, THE TOOTH BROKE HORIZONTALLY AT THE LOWER GINGIVAL 3RD. THE PATIENT SAW AN ENDODONTIST, WHO PERFORMED A ROOT CANAL AND PLACED A TEMPORARY CROWN, THEN A PERMANENT CROWN.