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	11/27/2017
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)(4) 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 third bracket that had been bonded to the same tooth; the previous brackets had been bonded on (b)(6) 2016 and (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 hard pizza crust when the ll5 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.
Additional Manufacturer Narrative
Per visual exam of the returned bracket, there is nothing unusual with the metal bracket or the shape of the bonding base; however, a thick adhesive layer with flash was still present and wrapped onto the top side of the bonding base.The mesh side of the bonding base was not visible due to the adhesive and enamel still attached.The 3m unitek instructions for use for apc ii adhesive, for bracket placement, indicates "gently remove excess adhesive around appliance base without disturbing the appliance." based upon the visual evaluation of the returned bracket, it appears that the excess adhesive may not have been removed upon bracket placement, which may have contributed to this event.In addition, it cannot be ascertained if the use of non-3m brand primer may have contributed to this event.

• 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: 7106467
• Report Number: 2020467-2017-00006
• Device Sequence Number: 16339209
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 01/31/2018
• 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: 15 YR