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 Abscess (1690); Tooth Fracture (2428)

Event Date 10/08/2021

Event Type  Injury  

Event Description

The customer reported gum infection that resulted in the loss of teeth #23 and 24 while wearing aligners.Medical intervention and medications' prescription was required to help addressing the reported incident.As a result, aligner treatment was discontinued.

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 related to loss of a tooth.As per capa #(b)(4) this event is retrospectively being reported and therefore was not reported within the required 30-days.

Manufacturer Narrative

Supplemental report for mdr 3014658399-2021-0136-1, additional manufacturing information provided in section d4 since it was not available at the time of initial submission.Besides, section g7 was corrected with the correct term.

• Brand Name: SMILEDIRECTCLUB ALIGNER SYSTEM
• Type of Device: SEQUENTIAL ALIGNER
• Manufacturer (Section D): ACCESS DENTAL LAB; 1530 antioch pike; antioch TN 37013
• Manufacturer Contact: bernie silvers ; 1530 antioch pike; antioch, TN 37013 ; 5127642249
• MDR Report Key: 13125444
• MDR Text Key: 283767586
• Report Number: 3014658399-2021-00136
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191990
• 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,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2021
• 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: 10/15/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/11/2021
• 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: 70 YR