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

Catalog Number	ASSY-500015
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Serious Injury
Event or Problem Description
In this event it is reported that a patient wearing suresmile retainer experienced the upper retainer impinging and cutting the patient's soft tissue on the lingual.
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.
Additional Manufacturer Narrative
Capa was opened to address elevated complaints for retainer fit issues.Contributing factors found.1.Machine is a contributing factor- wider digital blocking applied by the software.2.Method is a contributing factor- stand-alone retainers.3.Man is a contributing factor- distorted retainers.Determined root cause.1.Machine is a contributing factor.In this scenario, machine is the treatment planning software- suresmile software.¿ the software applies wider digital blocking to retainer models- wider and taller digital blocking results in a lack of retention which in turn makes the retainer loose and cause an improper fit.The software also doesn¿t have a warning system to flag these blockout issues.2.Method is a contributing factor.¿ this pertains to stand-alone retainers.For retainer-only orders (usually for patients who completed aligner treatment with other brands or those who haven¿t gone through suresmile aligners), the cases don¿t go through the treatment set-up process like aligners in digital lab.The digital file based on the scan is generated and moved to manufacturing for production without further review.Hence, factors affecting the treatment like gingival diseases, undercuts etc, that may affect the normal fit of the trays are not considered.3.Man is a contributing factor.¿ the retainers become distorted due to the extraction method used by operators.This is more applicable to retainers with shorter last molar heights.Immediate actions.1.Training operators on how to carefully extract the retainers without distorting them.This will address the distorted retainer issue.Required corrective actions.1.Update wi to add warning/ awareness on the extraction method that could cause distortion.2.Add an inspection method to detect distorted retainers on the production line.3.To mitigate the stand-alone retainer issue, doctors should be given the option to choose a scalloped trim line for a retainer which minimizes the fit issue.Currently, the only option provided for retainers are straight trim line.4.The software currently applies too much block-out which is one of the reasons for fit issues.Upgrade the software to improve the automatic block-out process.

• 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: 21696312
• Report Number: 1649995-2025-00018
• Device Sequence Number: 8730704
• Product Code: NXC
• UDI-Device Identifier: 00856379007269
• UDI-Public: 00856379007269
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

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
• Device Catalogue Number: ASSY-500015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/13/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown