MAUDE Adverse Event Report: 3M UNITEK CORPORAION APC FLASH-FREE VICTORY SERIES SUPERIOR FIT BUCCAL TUBE; ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

Catalog Number 4069-5114

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

Patient Problem Tooth Fracture (2428)

Event Date 09/27/2017

Event Type  Injury  

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 first device and manufacturer report 2020467-2017-00004 is related to the second device.

Event Description

On (b)(6) 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: APC FLASH-FREE VICTORY SERIES SUPERIOR FIT BUCCAL TUBE
• Type of Device: ADHESIVE, BRACKET AND TOOTH CONDITIONER, 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: 7054445
• MDR Text Key: 92838057
• Report Number: 2020467-2017-00003
• Device Sequence Number: 1
• Product Code: DYH
• UDI-Device Identifier: 00652221229021
• UDI-Public: 00652221229021
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113197
• 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: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 4069-5114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR