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 Codes	Tooth Fracture (2428); Tooth Loss (4831)
Date of Event	05/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The treating doctor reported that the patient had symptoms of tooth fracture and tooth loss involving ul5 and ul6, which split and broke at the gum level during treatment and were subsequently extracted.The patient did not report requiring any medical intervention as a result of the event.The patient did not report taking or being prescribed any medication to alleviate the reported symptoms.The treatment was discontinued on an unknown date and the patient is currently asymptomatic.
Additional Manufacturer Narrative
The current instructions for use contains the following: "precautions - a tooth that has been previously traumatized or significantly restored may be aggravated.In rare instances, the useful life of the tooth may be reduced, the tooth may require additional dental treatment such as endodontic and/or additional restorative work, and/or the tooth may be lost." the treating doctor shared that the potential root cause could have been that the affected teeth were already compromised and could not confirm whether the event was related to the use of the product.Align's clinical review noted that both ul5 and ul6 had pre-existing dental crowns, and ul6 demonstrated features consistent with prior endodontic treatment.The patient underwent two rounds of aligner treatment consisting of eight and nine aligners, with no significant programmed movement for the affected teeth.A comparison of scans from 2024 and 2025 identified a fracture in the distal structure of ul6.There is no conclusive evidence provided that supports or opposes whether the invisalign system caused or contributed to the reported permanent damage.Based on the available information, the patient had permanent damage, and the invisalign system was being used.Therefore, an mdr will be filed in the united states per 21 cfr 803.

• 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: 25621258
• Report Number: 2953749-2026-02206
• Device Sequence Number: 9101840
• Product Code: NXC
• UDI-Device Identifier: 00816063020196
• UDI-Public: (01)00816063020196(10)0240603872(13)251124(91)2556277012N
• 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): 06/25/2026

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: 240603872
• 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: 06/12/2026
• Initial Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2025
• 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: 68 YR
• Patient Sex: Female