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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/13/2021

Event Type  Injury  

Manufacturer Narrative

Based on the information provided by the patient and internal investigation conducted by access dental lab, 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 that describe tooth breakage.

Event Description

The customer reported that during aligner treatment teeth mobility developed and a tooth cracked.The customer is currently scheduled to receive medical intervention.The customer completed the aligner treatment plan.

Event Description

The customer reported that tooth #11 resulted in extraction.The customer required medical intervention from the general dentist and extracted the tooth.The customer is still wearing the aligners.

Manufacturer Narrative

Sections b3, b4, b5, g3 have been modified with additional information provided by the customer and h6 (health effect-clinical code/impact code/typer of investigation) has been modified according to the new information provided.

• Brand Name: SMILEDIRECTCLUB ALIGNER SYSTEM
• Type of Device: SEQUENTIAL ALIGNER
• Manufacturer (Section D): ACCESS DENTAL LAB; 1530 antioch pike; antioch TN 37103
• MDR Report Key: 12236233
• MDR Text Key: 263798476
• Report Number: 3014658399-2021-00031
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00850007728007
• UDI-Public: 0100850007728007
• Combination Product (y/n): N
• PMA/PMN Number: K191990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20 YR