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	04/01/2026
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 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.", "instructions for patients on proper oral hygiene - 1.Aligners should be removed for eating and drinking.Patients do not need to remove aligners to drink cool water.2.Patients should brush and floss their teeth after each meal or snack prior to re-inserting their aligners.If they don't have access to an invisalign cleaning system or a toothbrush, they can simply rinse their mouth, and then clean the aligners by holding them under warm running water.Aligners should be thoroughly cleaned at the patient's earliest convenience" the treating doctor shared that the tooth was not expected to be lost during treatment, however, clarified that the programmed orthodontic movements are not believed to be directly related to the outcome; however, it was noted that aligner use may have expedited the carious process due to the caries present.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.There is no conclusive evidence to confirm the date of the event, and the date (b3) is based on the timelines reported to align and compared to patient information.
Event or Problem Description
The treating doctor reported that the patient had symptoms of tooth loss involving tooth #5.The patient did not report requiring any medical intervention related to the reported event.The patient did not report taking or being prescribed any medication to alleviate the reported symptom.The patient is continuing treatment with the invisalign system and is currently reported to be doing well.

• 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: 25033295
• Report Number: 2953749-2026-01583
• Device Sequence Number: 18401945
• Product Code: NXC
• UDI-Device Identifier: 00816063020189
• UDI-Public: (01)00816063020189(10)0203845449(13)241127(91)2572361819N
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/29/2026

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: 203845449
• 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: 04/10/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2024
• 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: 61 YR
• Patient Sex: Male