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	Headache (1880); Pain (1994); Neuralgia (4413)
Date of Event	06/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The current instructions for use contains the following: "precautions - in rare instances, problems in the temporo-mandibular joint (jaw joint) may result in joint pain, headaches, or ear problems." trigeminal neuralgia compatible with the use of the aligners was identified as root cause by other doctors treating the patient.The treating doctor stated that the patient's reported history is not considered credible and confirmed that a refund has already been provided for the payment made.Based on the available information, the patient had hospitalization (initial or prolonged) and 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 patient reported symptoms of intense pain in the mouth and head, acute pain and extreme sensitivity in the upper right arch, inability to eat, inability to touch teeth or close the mouth, and progressive increase in pain throughout the right side of the head.The patient reported visiting the emergency room, a neurologist, head of dentist and general practitioner, pain management team and maxillofacial surgeon and required medical intervention, including hospitalization for five days due to uncontrolled pain.The patient indicated receiving intravenous morphine and unspecified intravenous neurological medication to alleviate the reported symptoms.It is unknown if the treatment was discontinued or if the patient is still using the invisalign system, and the patient's current condition is unknown.

• 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 orchad parkway; san jose, CA 95134
• MDR Report Key: 25595086
• Report Number: 2953749-2026-02202
• Device Sequence Number: 17488205
• Product Code: NXC
• UDI-Device Identifier: 00816063020189
• UDI-Public: (01)00816063020189(10)0237777834(13)251028(91)29904790XXN
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2026

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: 237777834
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2025
• 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; Hospitalization
• Patient Age: 40 YR
• Patient Sex: Female