MAUDE Adverse Event Report: Dentsply Sirona Orthodontics Inc. NONTEMPLATE ALIGNER ARCH; Aligner, Sequential

Catalog Number	00856379007023
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
In this event it is reported that there was a treatment planning issue for nontemplate aligner arch for a patient.The first setup was delivered as a non-extraction plan.Consequently, the doctor raised a complaint and requested a revision.The second setup was then correctly processed as an extraction plan.
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/serial number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.

• 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 ; +1(717)845-7511
• MDR Report Key: 50006127
• Report Number: 1649995-2026-00044
• Device Sequence Number: 16047873
• Product Code: NXC
• UDI-Device Identifier: 00856379007023
• UDI-Public: 00856379007023
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K171860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 07/23/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 00856379007023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown