MAUDE Adverse Event Report: ACCESS DENTAL LAB SMILEDIRECTCLUB RETAINER

Model Number N/A

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

Patient Problem Necrosis (1971)

Event Date 10/24/2022

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 retainers 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 led to necrosis of a tooth.This adverse event is being reported after 30 calendar days.During the evaluation of the complaint, it was found that the customer had reported the event before and it was not captured by the former complaint handling system.Capa-2021-007 was initiated in order to improve complaint handling system.

Event Description

The customer reported nerve damage on tooth #8 while wearing the retainers.Medical intervention is required, and a root canal needs to be performed.Retainer usage was not discontinued.For this event, the patient identifier is (b)(6) and the complaint number is (b)(4).

• Brand Name: SMILEDIRECTCLUB RETAINER
• Type of Device: RETAINER
• 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: 16057226
• MDR Text Key: 306236231
• Report Number: 3014658399-2022-00428
• Device Sequence Number: 1
• Product Code: DYT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• 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: 10/24/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/06/2022
• 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): Required Intervention; Other
• Patient Age: 35 YR