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

Catalog Number	00856379007023
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Type of Reportable Event	Serious Injury
Event or Problem Description
In this event it is reported that nontemplate aligner arch that a patient was using for treatment caused unintended movement of their teeth.Compared to the original plan (movement centered on upper and lower front teeth), an unexpected gap (gap) occurred between the upper left first molar and the canine tooth, which was not planned to move, and abnormal movement occurred due to improper alignment force or poor observation.
Additional Manufacturer Narrative
Since this event resulted in a serious injury, it is reportable per 21 cfr part 803.

• 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: 50054018
• Report Number: 1649995-2026-00047
• Device Sequence Number: 10636145
• Product Code: NXC
• UDI-Device Identifier: 00856379007023
• UDI-Public: 00856379007023
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/28/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2026
• Initial Report FDA Received Date: 07/28/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Not provided
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown