MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC. INVISALIGN SYSTEM - MODERATE; ALIGNER, SEQUENTIAL

Model Number	9001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tooth Loss (4831)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The current instructions for use contains the following: "a tooth that has been previously traumatized or significantly restored may be aggravated and/or the tooth may be lost." the potential root cause of this event was not identified.Align's clinical review of available records indicates that ur1 appeared clinically unremarkable at baseline; however, panoramic radiographs have diagnostic limitations.The tooth was lost two months after treatment initiation, and given the minimal planned movement across the previous and current aligners, the aligners are unlikely to have been the primary cause.Nonetheless, a causal role cannot be completely ruled out.No conclusive evidence has been provided that supports or opposes whether the invisalign secondary order aligners caused or contributed to the reported tooth loss.Based on the available information and clinical assessment, the permanent loss of ur1 constitutes permanent loss of body structure while the product was in use.Therefore, an mdr will be filed in the united states per 21 cfr 803.
Event or Problem Description
The treating doctor reported that the patient experienced the symptom of loss of tooth ur1.The patient did not require any medical intervention and was not prescribed any medications to address the reported event.The patient continued wearing the aligners, and the treating doctor confirmed the patient is currently doing well.

• Brand Name: INVISALIGN SYSTEM - MODERATE
• Common Device Name: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.; 2820 orchard parkway; san jose CA 95134
• Manufacturer (Section G): ALIGN TECHNOLOGY, INC.; 2820 orchard parkway; san jose CA 95134
• Manufacturer Contact: janier duarte santana ; 2820 orchard parkway; san jose, CA 95134
• MDR Report Key: 24240246
• Report Number: 2953749-2026-00185
• Device Sequence Number: 9220828
• Product Code: NXC
• UDI-Device Identifier: 00816063020196
• UDI-Public: (01)00816063020196(10)0240334957(13)250506(91)2634167607N
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K241412
• 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): 02/02/2026

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 Model Number: 9001
• Device Lot Number: 240334957
• 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: 01/08/2026
• Initial Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2025
• Is the Device Labeled for Single Use? (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: Disability
• Patient Age: 53 YR
• Patient Sex: Female