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

Model Number N/A

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

Patient Problems Abrasion (1689); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/03/2022

Event Type  Injury  

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 damaged crown (cracked dental restoration) and infection which the customer stated resulted in surgery.

Event Description

The customer reported a broken crown that led to an infection on #14 while wearing the aligners.Medical intervention was required and a surgery was performed.Aligner treatment was discontinued.For this event, the patient identifier is (b)(6) and the complaint number is (b)(4).

• Brand Name: SMILEDIRECTCLUB ALIGNER SYSTEM
• Type of Device: SEQUENTIAL ALIGNER
• Manufacturer (Section D): ACCESS DENTAL LA; 1530 antioch pike; antioch TN 37013
• Manufacturer Contact: john dargis ; 1530 antioch pike; antioch, TN 37013 ; 7736674753
• MDR Report Key: 14746813
• MDR Text Key: 294670950
• Report Number: 3014658399-2022-00140
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00850007728113
• UDI-Public: 0100850007728113
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• 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: 06/11/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 38 YR