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	05/07/2026
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 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.".No root cause provided.Align's clinical review that this tooth had a dental crown, and the panoramic radiograph shows findings consistent with prior endodontic therapy.The mesial root demonstrates a periapical radiolucency, suggestive of possible endodontic failure and a guarded overall prognosis.Prescription records indicate the patient used 20 aligners during the initial series and five in a subsequent set prior to the reported extraction.Both treatment plans included a button cutout designed for elastic use.While the programmed tooth movements for #3.6 appear minimal, the application of class ii elastics via the bonded button may have introduced additional forces, potentially exacerbating the already compromised condition of the tooth.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.The exact date of the event is unknown.Despite reasonable efforts, no conclusive information was available to determine when the event occurred.The date (b3) provided corresponds to the date the event was reported to the manufacturer and does not necessarily reflect the actual date of occurrence.
Event or Problem Description
The treating doctor reported that the patient had the symptom of extraction of tooth #3.6.No additional information is available at this time.Attempts to obtain additional information about the event were unsuccessful.

• 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: 25355077
• Report Number: 2953749-2026-01942
• Device Sequence Number: 16105298
• Product Code: NXC
• UDI-Device Identifier: 00816063020189
• UDI-Public: (01)00816063020189(10)0241299967(13)251201(91)2144234605N
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 06/01/2026

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: 241299967
• 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: 05/07/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2025
• 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: 48 YR
• Patient Sex: Female