MAUDE Adverse Event Report: 3M UNITEK CORPORAION 3M UNITEK INCOGNITO APPLIANCE SYSTEM; ORTHODONTIC WIRE

Catalog Number 358-110

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

There have been no other events of this nature reported to 3m for this product.The instructions for use state that the patient should be notified to contact their orthodontist about broken archwires or lost brackets immediately.

Event Description

On (b)(6) 2017, 3m was notified by an orthodontist that a (b)(6) male patient had swallowed a broken wire fragment of the 3m unitek incognito appliance system.The piece of wire was removed endoscopically (date unknown).According to the orthodontist there are no long-term consequences expected and the patient is doing well.

• Brand Name: 3M UNITEK INCOGNITO APPLIANCE SYSTEM
• Type of Device: ORTHODONTIC WIRE
• 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: 6580133
• MDR Text Key: 75598567
• Report Number: 2020467-2017-00001
• Device Sequence Number: 1
• Product Code: DZC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• 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: 02/14/2017

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: 358-110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/14/2017
• Initial Date FDA Received: 05/19/2017
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR