MAUDE Adverse Event Report: 3M HEALTH CARE 3M CLARITY ALIGNERS; ALIGNER, SEQUENTIAL

Model Number	358-455
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Sensitivity of Teeth (2427)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information: no information was provided.The device was not returned for evaluation.3m will continue to monitor.
Event or Problem Description
An orthodontist reported that a patient had a root canal performed on tooth #10 after difficulty experienced with removal of a 3m clarity aligner after overnight wear.The patient continued to wear the aligner and tooth #10 turned grey within the first week of wear.The patient visited an endodontist and the tooth was observed for a few weeks, after which a root canal with internal bleaching was performed.A composite on the lingual side is planned.

• Brand Name: 3M CLARITY ALIGNERS
• Common Device Name: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 10708618
• Report Number: 2020467-2020-00002
• Device Sequence Number: 11583721
• Product Code: NXC
• UDI-Device Identifier: 00652221236463
• UDI-Public: 00652221236463
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K192119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2020

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: Health Professional
• Device Expiration Date: 03/27/2023
• Device Model Number: 358-455
• Device Catalogue Number: 358-455
• Device Lot Number: VBM8702
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 10/20/2020
• 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: 43 YR