3M UNITEK APC II¿ CLARITY¿ ADVANCED MBT CERAMIC BRACKET
Received Jun 22, 2018 · Event occurred May 31, 2018
Report 2020467-2018-00001 · MDR key 7631096
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Tooth Fracture
- Tooth Fracture
Narrative
Additional Manufacturer Narrative
THIS EVENT MAY BE RELATED TO THE PREVIOUSLY COMPROMISED RESTORATION OF THE TOOTH. SINCE THIS EVENT INVOLVED TWO MEDICAL DEVICES, TWO MANUFACTURER REPORTS ARE BEING SUBMITTED. THIS REPORT (2020467-2018-00001) REPRESENTS THE FIRST MEDICAL DEVICE, AND 2020467-2018-00002 REPRESENTS THE SECOND DEVICE.
Description of Event or Problem
ON (B)(6) 2018, 3M WAS NOTIFIED THAT A FEMALE PATIENT, APPROXIMATELY (B)(6), HAD A LARGE BUCCAL FILLING BREAK OFF FROM A PREVIOUSLY RESTORED UPPER PRE-MOLAR TOOTH UPON DEBONDING OF A 3M APC II CLARITY ADVANCED CERAMIC BRACKET. THE BREAK WAS REPORTED TO BE DOWN TO DENTIN. THE BRACKET HAD BEEN IN PLACE FOR APPROXIMATELY 18 MONTHS. THE ORTHODONTIST REPORTED THAT THE LARGE FILLING/RESTORATION ON THE TOOTH DID NOT LOOK NORMAL. OTHER PRODUCTS USED WHEN THE BRACKET WAS INITIALLY BONDED INCLUDED A NON-3M BRAND ETCHANT. IN ADDITION, ALTHOUGH THE BRAND OF THE PRIMER OR CATALOG NUMBER WAS NOT DISCLOSED BY THE REPORTING FACILITY, BASED UPON A DESCRIPTION OF THE PRODUCT AND SALES HISTORY, IT IS SUSPECTED THAT 3M TRANSBOND PLUS SELF ETCHING PRIMER WAS ALSO POTENTIALLY USED.