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	Pain (1994); Swelling/ Edema (4577); Tooth Loss (4831)
Date of Event	11/05/2025
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 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" and "warnings, in rare instances, some patients may be allergic to the plastic aligner material".The treating doctor shared that the potential root cause could have been aligners pressure.Align's clinical review of available records indicates that gingival bleeding was present for teeth 2.7 and 2.8.No conclusive evidence has been provided that supports or opposes whether the invisalign system aligners caused or contributed to the required tooth extraction (permanent impairment), therefore, this event it is being filed as an mdr per 21 cfr 803.
Event or Problem Description
The treating doctor reported that the patient required a tooth extraction (tooth 2.8), swollen face and pain on distal side of this tooth.No additional information is available at this time.
Additional Manufacturer Narrative
Correction under brand name and model number, no impact on traceability.

• 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 nahomy duarte santana ; 2820 orchard parkway; san jose, CA 95134
• MDR Report Key: 21233022
• Report Number: 2953749-2025-00150
• Device Sequence Number: 12896127
• Product Code: NXC
• UDI-Device Identifier: 00816063020202
• UDI-Public: (01)00816063020202(10)0207302774(13)250106(91)2440429001N
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K241412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

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 Catalogue Number: 9002
• Device Lot Number: 207302774
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 07/04/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2025
• 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: 26 YR
• Patient Sex: Female