MAUDE Adverse Event Report: 3M UNITEK CORPORAION 3M UNITEK APC II GEMINI SL SELF-LIGATING BRACKET; ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

Catalog Number	3027-382
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	11/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The 3m unitek instructions for use state to instruct the patients not to chew or bite on hard substances such as hard candy, ice, carrots, etc.Careful and thorough patient instruction is key to avoiding appliance or enamel damage.
Event or Problem Description
On (b)(6) 2017, 3m was notified by an orthodontist that a patient brought a 3m unitek apc ii gemini sl bracket (ll5) to the office which debonded from tooth #20 with a piece of tooth enamel attached.This bracket was the second bracket that had been bonded to the same tooth; the previous bracket had been bonded on (b)(6) 2017, and the current bracket was bonded (b)(6) 2017.A non-3m brand primer was used during the bonding procedure.Upon follow-up by 3m, it was learned that the enamel damage was down to dentin.The patient admitted to eating halloween candy when the bracket came off.The orthodontist applied composite to fill in the affected area of enamel and re-bonded a non-3m brand bracket.The orthodontist plans to send the patient to their dentist for a permanent restoration at the end of orthodontic treatment.

• Brand Name: 3M UNITEK APC II GEMINI SL SELF-LIGATING BRACKET
• Common Device Name: ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN
• Manufacturer (Section D): 3M UNITEK CORPORAION; 2724 south peck rd.; monrovia CA 91016 5097
• MDR Report Key: 7106464
• Report Number: 2020467-2017-00005
• Device Sequence Number: 782117
• Product Code: DYH
• UDI-Device Identifier: 00652221226273
• UDI-Public: 00652221226273
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K911271
• 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): 12/11/2017

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: Other
• Device Catalogue Number: 3027-382
• 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: 11/13/2017
• Initial Report FDA Received Date: 12/11/2017
• 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