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

Catalog Number 712-090

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tooth Fracture (2428)

Event Date 05/31/2018

Event Type  Injury  

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 (2020467-2018-00004) represents the second medical device, and 2020467-2018-00003 represents the first device.

Event Description

On (b)(6) 2018, 3m was notified that a male patient, approximately (b)(6), had a large buccal filling break off from a previously restored upper pre-molar tooth 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
• Type of Device: AGENT, TOOTH BONDING, RESIN
• Manufacturer (Section D): 3M UNITEK CORPORATION; 2724 south peck rd.; monrovia CA 91016 5097
• Manufacturer (Section G): 3M UNITEK; 2724 south peck rd.; monrovia CA 91016 5097
• Manufacturer Contact: mark burville ; 2510 conway avenue; st. paul,
• MDR Report Key: 7631090
• MDR Text Key: 112096039
• Report Number: 2020467-2018-00004
• Device Sequence Number: 1
• Product Code: KLE
• UDI-Device Identifier: 00652221109170
• UDI-Public: 00652221109170
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 712-090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention