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

Catalog Number	ASSY-500011
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Malfunction
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.Investigation results: other: dl protocol was followed.Digital models, scan data, and staging looks good.Doctor did order a straight trim line which is good for this case, but if patient is in discomfort or having some irritation the practice can reorder the trays with a scalloped trim line to see if this will help.Dhr: we reviewed the dhr for this so-613so1516350 / patient id# (b)(6) / site id# (b)(6), qty.(b)(4) items assy-500011 (aligners) and 2 items assy-500010 (templates) were packaged by the second shift by auto bag-and-box operation on (b)(6) 2025, in manufacturing supercell sc1, equipment pua-07.Photo investigation: the evidence provided by the customer (photos) shows an upper aligner (u2, patient id: o4x8).It is observed that the device presents an apparent trim line with a sharp edge in the palatal area.Return: we received the return of (b)(4) items (68 aligners and 2 templates).We reviewed the aligners from the early stages (1¿3) and observed that the upper aligners present a sharp edge along the trim line in the palatal area.
Event or Problem Description
In this event it is reported that a patient experienced non-template aligner arch causing bleeding.After investigation it was found the aligners have sharp edges causing the bleeding.
Additional Manufacturer Narrative
The date received by manufacturer in the initial report was incorrect.We became aware of the sharp edges malfunction during investigation of the device.The date received by manufacturer has been corrected in this report.

• 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: 24317071
• Report Number: 1649995-2026-00005
• Device Sequence Number: 4875756
• Product Code: NXC
• UDI-Device Identifier: 00856379007023
• UDI-Public: 00856379007023
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K171860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

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-500011
• Device Lot Number: 11366251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2026
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/20/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown