MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC. INVISALIGN FULL; ALIGNER, SEQUENTIAL

Model Number	8500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Laceration(s) (1946); Discomfort (2330); Tooth Loss (4831)
Date of Event	11/01/2025
Type of Reportable Event	Serious Injury
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 potential root cause of this event is unknown.Align's clinical review of available records indicates that a comparison between the latest scan ((b)(6) 2023) and the initial scan ((b)(6) 2021) shows the absence of tooth ll6.No conclusive evidence has been provided that supports or opposes whether the invisalign system aligners caused or contributed to the reported tooth loss.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 treated patient reported having a tooth extracted from the lower arch (unknown tooth), along with experiencing discomfort and cuts.When the clinic was contacted, the staff explained that this is an old case and that they typically do not recommend extractions.The extractions were performed by the patient's general dentist, and the clinic is unaware of the reason for these procedures.The clinic staff clarified that there were no notes indicating that the aligners caused harm to the patient.No additional information is available at this time.

• Brand Name: INVISALIGN FULL
• 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: 23696086
• Report Number: 2953749-2025-03099
• Device Sequence Number: 9211238
• Product Code: NXC
• UDI-Device Identifier: 00816063020004
• UDI-Public: (01)00816063020004(10)0141155994(13)230202(91)07218419XXN
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2025

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: 8500
• Device Lot Number: 141155994
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2023
• 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: 33 YR
• Patient Sex: Female