MAUDE Adverse Event Report: ACCESS DENTAL LAB SMILEDIRECTCLUB ALIGNER SYSTEM; SEQUENTIAL ALIGNER

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that tooth #10 broke while wearing the aligners.Medical intervention was required, and an extraction was performed.Aligner treatment was discontinued.For this event, the patient identifier is c3d010cfe59c89 and the complaint number is id-(b)(4).
Additional Manufacturer Narrative
Based on the information provided by the patient, there is no conclusive evidence that supports or opposes the fact that the aligners caused, contributed, or would likely cause or contribute to the reported event.This event is being filed as an mdr since the patient reported symptoms or physiological conditions related to tooth breakage which the customer stated resulted in extraction of the tooth.This adverse event is being reported after 30 calendar days.This event was original classified under a non-reportable category within the complaint handling system.

• Brand Name: SMILEDIRECTCLUB ALIGNER SYSTEM
• Common Device Name: SEQUENTIAL ALIGNER
• Manufacturer (Section D): ACCESS DENTAL LAB; 1530 antioch pike; antioch TN 37013
• Manufacturer Contact: john dargis ; 1530 antioch pike; antioch, TN 37013 ; 7736774753
• MDR Report Key: 15663465
• Report Number: 3014658399-2022-00376
• Device Sequence Number: 15070482
• Product Code: NXC
• UDI-Device Identifier: 00850007728014
• UDI-Public: 0100850007728014
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K191990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2021
• Initial Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Other
• Patient Age: 51 YR
• Patient Sex: Unknown