MAUDE Adverse Event Report: 3M HEALTH CARE 3M INCOGNITO APPLIANCE SYSTEM - ARCHWIRE; WIRE, ORTHODONTIC

Catalog Number 358-252

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/18/2020

Event Type  Injury  

Manufacturer Narrative

The sample was not returned for evaluation.The root cause was unable to be determined without the sample.3m will continue to monitor.Archwires can break under certain conditions.E.G.Extreme misplacement of teeth, strong patient bite, chewing motions, specific patient habits, hard food (nuts, cherry pits).Archwire breakage and swallowing of pieces occurs rarely.We will continue monitoring for similar events.

Event Description

According to the customer the lower 3m¿ incognito¿ appliance system - archwire (14rd niti) broke and a 2.5 cm piece of wire was swallowed.The piece was removed at a hospital the same day by gastroenteroscopy.The patient is reported well and missed only 1-2 hours of working time.No long term effects are anticipated.

• Brand Name: 3M INCOGNITO APPLIANCE SYSTEM - ARCHWIRE
• Type of Device: WIRE, ORTHODONTIC
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul, mn
• Manufacturer (Section G): TOP-SERVICE FÜR LINGUALTECHNIK GMBH - A 3M COMPANY; schledehauser str. 81; bad essen, germany 49152 ; GM 49152
• Manufacturer Contact: suzanne leung ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, mn ; 7379117
• MDR Report Key: 10292269
• MDR Text Key: 199493520
• Report Number: 2020467-2020-00001
• Device Sequence Number: 1
• Product Code: DZC
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 358-252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2020
• 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