MAUDE Adverse Event Report: Align Technology, Inc. Invisalign System - Comprehensive; ALIGNER, SEQUENTIAL

Model Number	9000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tooth Loss (4831)
Date of Event	08/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The treating doctor reported that the patient had symptoms associated with complications involving tooth ul7, resulting in its extraction.No additional information is available at this time.Attempts to obtain additional information about the event were unsuccessful.
Additional Manufacturer Narrative
Align's clinical review noted that in the initial occlusogram demonstrated very limited occlusal support, with occlusal contacts restricted to only a few posterior teeth, including ul7.A gold crown was present on ul7, indicating prior restorative treatment.The complaint reported uprighting of tooth ul8, which had been mesialized using a sectional fixed appliance after complications involving ul7 resulted in extraction, while the patient was using an invisalign system secondary order at stage 20.Multiple attempts were made to contact the treating doctor for additional information, including phone calls and email, but no further information was obtained.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.The exact date of the event is unknown.Despite reasonable efforts, no conclusive information was available to determine when the event occurred.The date (b3) provided corresponds to the date the event was reported to the manufacturer and does not necessarily reflect the actual date of occurrence.

• Brand Name: Invisalign System - Comprehensive
• 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: 50253324
• Report Number: 2953749-2026-02239
• Device Sequence Number: 21334168
• Product Code: NXC
• UDI-Device Identifier: 00816063020189
• UDI-Public: (01)00816063020189(10)0222404932(13)250602(91)2461552420N
• 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): 08/14/2026

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: 9000
• Device Lot Number: 222404932
• 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: 08/02/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2025
• 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: 28 YR
• Patient Sex: Male