MAUDE Adverse Event Report: 3M UNITEK CORPORAION 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	09/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since two 3m unitek products were involved in this event, two manufacturer reports are being filed.The current manufacturer report is related to the second device and manufacturer report 2020467-2017-00003 is related to the first device.
Event or Problem Description
On october 27, 2017, 3m was notified by an orthodontist that the top layer of enamel broke off a (b)(6) male patient's tooth (#3) upon debonding of a 3m unitek apc flash free victory series fit buccal tube.3m unitek transbond plus self-etching primer was used to place the bracket.The orthodontist sent the patient to their dentist to have the tooth repaired.Upon follow-up by 3m with the orthodontist, it was learned that the enamel damage was down to dentin and the orthodontist reported that the tooth appeared to be normal prior to this event.

• Brand Name: TRANSBOND PLUS SELF-ETCHING PRIMER
• Common Device Name: AGENT,TOOTH BONDING RESIN
• Manufacturer (Section D): 3M UNITEK CORPORAION; 2724 south peck rd.; monrovia CA 91016 5097
• MDR Report Key: 7054444
• Report Number: 2020467-2017-00004
• Device Sequence Number: 13775496
• Product Code: KLE
• UDI-Device Identifier: 00652221109170
• UDI-Public: 00652221109170
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/22/2017

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: Dentist
• 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: 10/27/2017
• Initial Report FDA Received Date: 11/22/2017
• 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
• Patient Age: 13 YR