MAUDE Adverse Event Report: Ortho Dental Lab, LLC SmileSet; SmileSet Retainer

Model Number	140-0101
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The retainer pulled off a crown on removal.
Additional Manufacturer Narrative
This mdr is being filed due to a retrospective review.No conclusive evidence has been provided that supports or opposes the fact that the smileset retainers caused or contributed to the patient's symptoms.This event is being filed as a mdr as the patient reported a dislodged crown while a smileset retainer was being used.

• Brand Name: SmileSet
• Common Device Name: SmileSet Retainer
• Manufacturer (Section D): Ortho Dental Lab, LLC; 1530 antioch pike; antioch TN 37013
• Manufacturer (Section G): ORTHO DENTAL LAB, LLC; 1530 antioch pike; antioch TN 37013
• Manufacturer Contact: josh kessler ; 1530 antioch pike; antioch, TN 37013
• MDR Report Key: 50555985
• Report Number: 3032193293-2026-00021
• Device Sequence Number: 10651565
• Product Code: KMY
• UDI-Device Identifier: 00860012825592
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: 140-0101
• Device Catalogue Number: 140-0101
• Device Lot Number: 178765
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown