MAUDE Adverse Event Report: DENTSPLY SIRONA ORTHODONTICS INC. SURESMILE RETAINER; ALIGNER, SEQUENTIAL

Catalog Number	ASSY-500015
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a patient experienced bleeding of upper anterior gums caused by the suresmile retainer that were cutting the gums.Patient was re-scanned by doctor and new retainers have been ordered.
Additional Manufacturer Narrative
There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

• Brand Name: SURESMILE RETAINER
• Common Device Name: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): DENTSPLY SIRONA ORTHODONTICS INC.; 2350 campbell creek blvd. suit; richardson TX 75082
• Manufacturer (Section G): DENTSPLY SIRONA ORTHODONTICS INC.; 2350 campbell creek blvd. suit; richardson TX 75082
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 21718167
• Report Number: 1649995-2025-00019
• Device Sequence Number: 14418629
• Product Code: NXC
• UDI-Device Identifier: 00856379007269
• UDI-Public: 00856379007269
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: ASSY-500015
• Device Lot Number: 10098360
• Distributor Facility Aware Date: 03/27/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Female