MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC. INVISALIGN EXPRESS 10; ALIGNER, SEQUENTIAL

Model Number	8512
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	02/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The treating doctor reported that the patient's tooth #12 broke and it is now treatment planned for extraction.The patient is still wearing the invisalign treatment.No additional information is available at this time.
Additional Manufacturer Narrative
*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".The treating doctor shared that the potential root cause of this event could have been poor fit of aligners and very tight compression.Align's clinical review of available records indicate that tooth #12 had a preexistent restoration.The patient had a tooth fracture while the invisalign system aligners were being used and will now require a tooth extraction (permanent impairment of a body structure), therefore; this event is being filed as an mdr 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 the patient information.

• Brand Name: INVISALIGN EXPRESS 10
• 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: adriana solis ; 2820 orchard parkway; san jose, CA 95134
• MDR Report Key: 21630171
• Report Number: 2953749-2025-00418
• Device Sequence Number: 8350502
• Product Code: NXC
• UDI-Device Identifier: 00816063020042
• UDI-Public: (01)00816063020042(10)0182725129(13)240424(91)718476001N
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/18/2025

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: 8512
• Device Lot Number: 182725129
• 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: 02/21/2025
• Initial Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2024
• 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: 60 YR
• Patient Sex: Female