MAUDE Adverse Event Report: SPARK; SPARK ADVANCED

Catalog Number	UNKNOWN
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	12/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Spark manufacturing was unable to identify the reported patient as a spark aligner user.A review of internal records, including patient name searches and inquiries with the identified orthodontic provider's patient population, did not identify a matching spark case.As a result, the manufacturer was unable to confirm that spark aligners were used by the reporter.No device was returned for evaluation.No lot number, serial number, or aligner stage information was available.The manufacturer could not verify device involvement or assess device performance.Based on the limited information available, the relationship between the reported dental findings and the use of spark aligners could not be determined.This report is submitted in compliance with medical device reporting requirements.Should additional information become available, ormco will submit a supplemental report.Ormco does not have any role, authority, or influence in determining patient treatment plans.The company encourage the patient to discuss any questions or concerns directly with their healthcare provider, as they are fully responsible for guiding the patient's treatment.Ref.Mw5181610.
Event or Problem Description
It was reported a patient began treatment with spark aligners and, after two months of use, developed significant cracking of the anterior teeth.Due to the severity of the fractures, the affected teeth will require extraction.

• Brand Name: SPARK
• Common Device Name: SPARK ADVANCED
• Manufacturer Contact: procoro herrera ; 200 s kraemer blvd; brea, CA 92821
• MDR Report Key: 24381658
• Report Number: 2016150-2026-00001
• Device Sequence Number: 18688359
• Product Code: NXC
• UDI-Device Identifier: 00889989083460
• UDI-Public: 00889989083460
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2026

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
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 02/18/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Race: White