MAUDE Adverse Event Report: DENTSPLY SIRONA ORTHODONTICS INC. NONTEMPLATE ALIGNER ARCH; ALIGNER, SEQUENTIAL

Catalog Number	00856379007023
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Sharp Edges (4013)
Health Effect - Clinical Codes	Inflammation (1932); Laceration(s) (1946); Deformity/ Disfigurement (2360)
Type of Reportable Event	Serious Injury
Event or Problem Description
In this event it is reported by the patient that a nontemplate aligner arch - suresmile aligner caused cuts and irritation to the patient.Patient also had complaints of aligners breaking and no adjustment of the treatment being made despite their repeated complaints and catastrophic occlusion and an incomplete treatment that is far from successful, resulting in physical, moral, and financial damage.
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.
Additional Manufacturer Narrative
Investigation results: dl protocol was followed.Digital models, ct data, setup, and staging all look good.I do not see any issues with the trim line, but if the patient complained of discomfort or unsatisfied the dr should have called the clinical team and asked for a clinical consult.Or sent in a refinement with notes stating the issues from the patients prospective.It seems the patient is observant and usually those types of patient are very compliant.I feel that this is a disconnect with the dr.And not with the actual aligners.Dhr: we reviewed the dhr for this (b)(6) / patient id# (b)(6) / site id# (b)(4), qty.(b)(4) items assy-500011 (aligners) and 2 items assy-500010 (templates) were packaged by the first shift by bag-and-box operation on (b)(6), 2024, in manufacturing cell 1, equipment bag-2.The sales order was inspected and met the acceptance criteria provided by qa.Incoming inspection.We reviewed the incoming inspection record for the material manufacturing of this (b)(6).· raw material: part-501017-b / lot# 08612175 / qty.Received = (b)(4) pcs, inspection date: (b)(6) 2024.The material was found acceptable for use in the suresmile product's manufacture.Failure mode - fit issue.Root cause - no defect.Conclusion code - no failure found.
Additional Manufacturer Narrative
Additional information received that the evidence provided by the customer shows a set of aligners from stages 11¿23, patient id: (b)(6), sales order: so-(b)(4).We observe that the lower aligners from each stage show damage (cracks/broken) in the trays of the right molars.

• Brand Name: NONTEMPLATE ALIGNER ARCH
• 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: 23717735
• Report Number: 1649995-2025-00075
• Device Sequence Number: 8910510
• Product Code: NXC
• UDI-Device Identifier: 00856379007023
• UDI-Public: 00856379007023
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K171860
• 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,Followup
• Report Date (Section B): 02/11/2026

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 Catalogue Number: 00856379007023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/25/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/18/2025; 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Unknown