MAUDE Adverse Event Report: 3M UNITEK CORPORAION 3M UNITEK NITINOL CL OFIII OVOID L014; ORTHODONTIC WIRE

Catalog Number 4296-518

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

Patient Problem Foreign Body In Patient (2687)

Event Date 10/08/2016

Event Type  malfunction  

Event Description

On november 22, 2016, 3m was notified by a dental office in (b)(6) that a (b)(6) female patient had swallowed a broken piece of a 3m unitek nitinol classic archwire on (b)(6) 2016.The orthodontic wire was placed in (b)(6) 2016.The wire was excreted in the patients stool without incident.While no injury occurred, this event is being reported because of the potential for serious injury.

• Brand Name: 3M UNITEK NITINOL CL OFIII OVOID L014
• 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: 6187909
• MDR Text Key: 63191249
• Report Number: 2020467-2016-00005
• Device Sequence Number: 1
• Product Code: DZC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 11/22/2016

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: Dentist
• Device Catalogue Number: 4296-518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2016
• Initial Date FDA Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14 YR