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	Muscle Weakness/Atrophy (1967); Facial Paralysis (4585)
Date of Event	09/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The treating doctor reported that the patient had symptoms of paralysis/weakness affecting one side of the face, inability to move the tongue, significant difficulty swallowing, inability to open the jaw, difficulty speaking, jaw spasms, and dystonia.The patient reported hospitalization for two days beginning on (b)(6) 2026.The patient indicated taking akineton (biperiden) and antihistamines to alleviate the reported symptoms.No known pre-existing allergies or medical conditions were reported.No laboratory or clinical tests were performed.The treatment with the invisalign system was discontinued on (b)(6) 2026 and, at the time of reporting, the patient was improving.
Additional Manufacturer Narrative
The current instructions for use contains the following: "precautions - in rare instances, problems in the temporo-mandibular joint (temporo-mandibular disorder (tmd)) may result in joint pain, headaches, or ear problems.During forward posturing and vertical changes with mandibular advancement features, problems in the temporo-mandibular joint may be exacerbated." the treating doctor shared that the potential root cause could have been jaw spasms that may have been triggered by aligner use; however, the treating doctor stated on two separate occasions that a causal relationship between the invisalign system and the reported event could not be established or confirmed.The treating doctor was unable to provide medical records, hospitalization records, a medical certificate, laboratory results, or clinical photographs for further evaluation.There is no conclusive evidence provided that supports or opposes whether the invisalign system caused or contributed to the reported hospitalization (initial or prolonged).Based on the available information, the patient had hospitalization (initial or prolonged), and the invisalign system was being used.Therefore, an mdr will be filed in the united states per 21 cfr 803.

• 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: 50947201
• Report Number: 2953749-2026-02271
• Device Sequence Number: 9624025
• Product Code: NXC
• UDI-Device Identifier: 00816063020189
• UDI-Public: (01)00816063020189(10)0264398521(13)260707(91)3259024903N
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 09/30/2026

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: 264398521
• 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: 09/18/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2026
• 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: Hospitalization
• Patient Age: 37 YR
• Patient Sex: Female