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 Codes	Bacterial Infection (1735); Tooth Loss (4831)
Date of Event	07/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
He 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 noted initial upper occlusal photographs showed a restoration with signs of marginal leakage and a fractured mesiobuccal portion of the tooth.Subsequent photographs obtained during an additional aligner phase in october 2024 showed further deterioration of the restoration and brownish discoloration along the mesial margin.Images from april 2026, following completion of an additional 34 aligners, showed that tooth 1.7 had been restored and that the palatal aspect of the restoration appeared fractured.Clinical records documented progressive changes in the condition of tooth 1.7 during treatment.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 symptoms of severe tooth infection, tooth extraction (tooth 1.7), buccal decay on tooth 4.7, and upper and lower aligners not fitting properly.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: 25907765
• Report Number: 2953749-2026-02225
• Device Sequence Number: 17602692
• Product Code: NXC
• UDI-Device Identifier: 00816063020189
• UDI-Public: (01)00816063020189(10)0257155373(13)260429(91)2267098503N
• Combination Product (Y/N): N
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2026

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: 257155373
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 07/22/2026
• Supplement Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2026
• 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: 34 YR
• Patient Sex: Female