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	Fistula (1862); 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 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 could have been the acceleration of a pre-existing periapical lesion associated with aligner use.Align's clinical review that tooth 4.6 had a pre-existing radiolucent periapical lesion prior to aligner therapy, an inadequate endodontic treatment described as short, a large coronal restoration, and vertical bone loss defects on both mesial and distal aspects.There is no conclusive evidence provided that supports or opposes whether the invisalign system caused or contributed to the reported disability or permanent damage.Based on the available information, the patient had disability or 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 of tooth 4.6, fistula formation, and grade i tooth mobility.The patient indicated being prescribed clavulin (amoxicillin/clavulanic acid) to alleviate the reported symptoms following the extraction.It is unknown if any clinical or laboratory tests were performed.The patient is continuing treatment with the invisalign system and is currently asymptomatic.

• 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: 24952906
• Report Number: 2953749-2026-01537
• Device Sequence Number: 13234260
• Product Code: NXC
• UDI-Device Identifier: 00816063020189
• UDI-Public: (01)00816063020189(10)0215477411(13)250325(91)2733558233N
• 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): 04/22/2026

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: 215477411
• 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: 04/06/2026
• Initial Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2025
• 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: 37 YR
• Patient Sex: Male