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

Model Number	9002
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	12/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The current instructions for use (ifu) contains the following: "precautions - a tooth that has been previously traumatized or significantly restored may be aggravated.In rare instances, the 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 tooth was not planned for extraction, however, the patient had severe pain.The potential root cause of this event could be the tooth fracture.Align's clinical review of available records shows tooth #16 did not appear to have restorations or significant recession that would indicate a clinically compromised condition.No conclusive evidence has been provided that supports or opposes whether the invisalign system aligners caused or contributed to the tooth loss (permanent damage) and the invisalign system aligners were being used.Therefore, an mdr is being filed in the united states per 21 cfr 803.There is no conclusive evidence to confirm the date of the required tooth extraction, and the date (b3) is based on the timelines reported to align and compared to patient information.
Event or Problem Description
The treating doctor shared that the patient developed pain on tooth #16, there was a fracture in this tooth and required extraction.It is unknown if the patient required any additional medical intervention or medication to alleviate the reported symptoms.No additional information at this time.

• Brand Name: INVISALIGN SYSTEM - LITE
• 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: 24095378
• Report Number: 2953749-2026-00143
• Device Sequence Number: 10397326
• Product Code: NXC
• UDI-Device Identifier: 00816063020202
• UDI-Public: (01)00816063020202(10)0233698781(13)250918(91)2956818905N
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/16/2026

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: 9002
• Device Lot Number: 233698781
• 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: 12/23/2025
• Initial Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2025
• 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: 45 YR
• Patient Sex: Male