MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC. INVISALIGN SYSTEM - MODERATE; ALIGNER, SEQUENTIAL

Model Number	9001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Skull Fracture (2077)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
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 health of the bone and gums which support the teeth may be impaired or aggravated.".The treating doctor shared that the potential root cause could have been a thin maxillary plate.The align clinical review noted planned movements of 3.4 mm of lingual crown translation, 2.5 mm of buccal root translation, 19.9° of lingual inclination, and 19.9° of buccal root inclination.There is no conclusive evidence provided that supports or opposes whether the invisalign primary order caused or contributed to the reported disability or permanent damage.Based on the available information, the patient had a maxillary fracture (disability or permanent damage), and the invisalign primary order was being used.Therefore, an mdr will be filed in the united states per 21 cfr 803.The date (b3) is compared to patient information.
Event or Problem Description
The treating doctor reported that the patient started developing symptoms of discoloration of the upper left central incisor on (b)(6) 2025.On (b)(6) 2025, elective endodontic treatment was performed on tooth 2.1.On (b)(6) 2026, again presented sensitivity to hot and cold on tooth 1.1.An iopa was performed to evaluate, no significant findings, however; when a cbct was performed, revealed a fracture of the anterior maxilla.The patient did not report having any pre-existing medical conditions and did not take any medications regularly.The patient indicated being prescribed steroids dexamethasone 4 mg twice daily for three days and paracetamol (pcm) 1 g three times daily for three days to alleviate the reported symptoms.The treatment was discontinued on (b)(6) 2026 and the patient is currently awaiting further guidance while placed on retainers.

• Brand Name: INVISALIGN SYSTEM - MODERATE
• 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: 24369065
• Report Number: 2953749-2026-00235
• Device Sequence Number: 9652403
• Product Code: NXC
• UDI-Device Identifier: 00816063020196
• UDI-Public: (01)00816063020196(10)0215603898(13)250326(91)2755787607N
• Combination Product (Y/N): N
• Initial Reporter Country: KE
• 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): 02/17/2026

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: 9001
• Device Lot Number: 215603898
• 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: 01/20/2026
• Initial Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2025
• 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: 30 YR
• Patient Sex: Female