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 Post Traumatic Wound Infection (2447); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/29/2022

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 that describe loss of dental bone structure and teeth infection.

Event Description

The customer reported an infection and bone loss on teeth #23 #24 #25 #26 while wearing the aligners.Medical intervention is required, and root canals will be perform.It is unknown if 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 LAB; 1530 antioch pike; antioch TN 37013
• Manufacturer Contact: joan ceasar ; 1530 antioch pike; antioch, TN 37013 ; 7135918304
• MDR Report Key: 16116819
• MDR Text Key: 306844718
• Report Number: 3014658399-2022-00459
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00850007728021
• UDI-Public: (01)00850007728021
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K212496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/06/2023

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
• 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
• Initial Date Manufacturer Received: 12/29/2022
• Initial Date FDA Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/07/2022
• Is the Device Single Use?: No
• 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: 42 YR