MAUDE Adverse Event Report: 3M UNITEK CORPORAION 3M UNITEK TRANSBOND (TM) 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 11/21/2017

Event Type  Injury  

Manufacturer Narrative

Since this event involved two medical devices, two manufacturer reports are being submitted.This report represents the second medical device, and 2020467-2017-00007 represents the first device.

Event Description

On (b)(6) 2017, 3m was notified that a (b)(6) 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 TRANSBOND (TM) PLUS SELF ETCHING PRIMER
• Type of Device: AGENT, TOOTH BONDING, RESIN
• Manufacturer (Section D): 3M UNITEK CORPORAION; 2724 south peck rd.; monrovia CA 91016 5097
• Manufacturer (Section G): 3M UNITEK; 2724 south peck rd.; monrovia CA 91016 5097
• Manufacturer Contact: angie draper ; 2510 conway avenue; st. paul, MN 55144-1000 ; 6517331179
• MDR Report Key: 7134792
• MDR Text Key: 95388845
• Report Number: 2020467-2017-00008
• 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: 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
• 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
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR