MAUDE Adverse Event Report: 3M UNITEK CORPORATION APC(TM) FLASH-FREE CLARITY(TM) ADVANCED CERAMIC BRACKET; CERAMIC ORTHODONTIC BRACKET

Catalog Number	4006-250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	09/22/2016
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
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.

• Brand Name: APC(TM) FLASH-FREE CLARITY(TM) ADVANCED CERAMIC BRACKET
• Common Device Name: CERAMIC ORTHODONTIC BRACKET
• Manufacturer (Section D): 3M UNITEK CORPORATION; 2724 south peck rd; monrovia CA 91016 5097
• MDR Report Key: 6046138
• Report Number: 2020467-2016-00004
• Device Sequence Number: 19187564
• Product Code: NJM
• UDI-Device Identifier: 00652221166005
• UDI-Public: 00652221166005
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K102803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Dental Hygienist
• Device Catalogue Number: 4006-250
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2016
• Initial Report FDA Received Date: 10/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ORTHODONTIC ARCHWIRES
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 15 YR