MAUDE Adverse Event Report: ORTHO DENTAL LAB, LLC SmileSet; SmileSet Retainer

Model Number	141-0101
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	07/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Molar pain when biting; molar later broke while eating; crown subsequently placed on the affected tooth (cross-referenced case (b)(4)).
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 broken molar 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: 50555987
• Report Number: 3032193293-2026-00024
• Device Sequence Number: 18804438
• Product Code: KMY
• UDI-Device Identifier: 00860012825592
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 141-0101
• Device Catalogue Number: 141-0101
• Device Lot Number: 137243
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown