MAUDE Adverse Event Report: 3M UNITEK CORPORAION 3M UNITEK APC¿ FLASH-FREE CLARITY¿ ADVANCED MBT; BRACKET, CERAMIC, ORTHODONTIC

Catalog Number	4006-313
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	11/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The ifu for 3m unitek clarity advanced ceramic brackets does contain a warning that states "instruct patients not to chew or bite on hard substances such as hard candy, ice, carrots, etc.Careful and thorough patient instruction is a key to avoiding appliance or enamel damage." since this event involved two medical devices, two manufacturer reports are being submitted.This report (2020467-2017-00007) represents the first medical device, and 2020467-2017-00008 represents the second device.
Event or Problem Description
On (b)(6), 2017, 3m was notified that a (b)(6) old male patient had a 3m unitek apc flash-free clarity advanced upper left bicuspid bracket (ul5) debond from tooth #13 while eating an apple.The debonded bracket contained tooth enamel.The orthodontist removed the bracket that was still attached to the archwire and sent the patient to his dentist for restoration of the enamel.Upon 3m follow-up with the orthodontist, enamel damage down to dentin was reported.The bracket was initially placed on (b)(6) 2016.Other products used when the bracket was placed included a non-3m etchant and 3m unitek transbond plus self-etching primer.

• Brand Name: 3M UNITEK APC¿ FLASH-FREE CLARITY¿ ADVANCED MBT
• Common Device Name: BRACKET, CERAMIC, ORTHODONTIC
• Manufacturer (Section D): 3M UNITEK CORPORAION; 2724 south peck rd.; monrovia CA 91016 5097
• MDR Report Key: 7134783
• Report Number: 2020467-2017-00007
• Device Sequence Number: 11030070
• Product Code: NJM
• UDI-Device Identifier: 00652221217806
• UDI-Public: 00652221217806
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K102803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/19/2017

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: Other
• Device Catalogue Number: 4006-313
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 12/20/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 14 YR