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

Catalog Number	ASSY-500015
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
In this event it is reported that the patient experienced difficulty removing suresmile retainer this resulted to injury to their gums.
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 was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.
Additional Manufacturer Narrative
Investigation results: dl protocol was followed for retainer model 1 i do not see any issues with the models.Patient was complaining it was too tight.I do see that they have submitted a ss3 so that they can have passive trays to use as a retainer model with a scalloped trim line.This should be more comfortable for the patient and easier to remove.Ss3 is in review for the dr.We reviewed the dhr for so-155511so00054466 / patient id#: (b)(6) / site id#: 55617, qty.1 items assy-500015 (retainer) were packaged by the second shift by auto bag-and-box operation on (b)(6) 2025, in manufacturing cell 1, equipment bag-15.The sales order was inspected and met the acceptance criteria provided by qa.Failure mode - treatment planning issue, root cause - no defect, conclusion code - no failure found.

• 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: 21422294
• Report Number: 1649995-2025-00009
• Device Sequence Number: 15364192
• Product Code: NXC
• UDI-Device Identifier: 00856379007269
• UDI-Public: 00856379007269
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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
• Device Catalogue Number: ASSY-500015
• Device Lot Number: 09894000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/18/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown