MAUDE Adverse Event Report: 3M UNITEK CORPORATION 3M UNITEK TRANSBOND PLUS SELF ETCHING PRIMER; AGENT, TOOTH BONDING, RESIN

Catalog Number	712-090
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	05/31/2018
Type of Reportable Event	Serious Injury
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 (2020467-2018-00002) represents the second medical device, and 2020467-2018-00001 represents the first device.
Event or Problem Description
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.

• Brand Name: 3M UNITEK TRANSBOND PLUS SELF ETCHING PRIMER
• Common Device Name: AGENT, TOOTH BONDING, RESIN
• Manufacturer (Section D): 3M UNITEK CORPORATION; 2724 south peck rd.; monrovia CA 91016 5097
• MDR Report Key: 7631099
• Report Number: 2020467-2018-00002
• Device Sequence Number: 16592956
• Product Code: KLE
• UDI-Device Identifier: 00652221109170
• UDI-Public: 00652221109170
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K001494
• 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): 06/22/2018

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: 712-090
• 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: 06/01/2018
• Initial Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention