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	Pain (1994); Loss of Range of Motion (2032); Sensitivity of Teeth (2427); Joint locking (2672)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The treating doctor reported that the patient has been diagnosed with left temporomandibular joint (tmj) anterior disc displacement without reduction, had symptoms of jaw locking on the left side, inability to open the mouth properly, and pain upon attempting to open the mouth, as well as sensitivity while eating and speaking.The patient reported visiting a specialist and required medical intervention consisting of arthrocentesis, with regenerative medicine planned.The patient indicated taking a muscle relaxant to alleviate the reported symptoms.The treatment was discontinued on 12/9/2025 and the patient is currently experiencing mild persistent symptoms, including sensitivity while eating and speaking.
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.".Potential root cause not identified.When asked how is the patient doing by now treating doctor shared the following: symptoms persists sensitivity while eating and speaking, is currently mild.There is no conclusive evidence provided that supports or opposes whether the invisalign system caused or contributed to the reported required intervention to prevent permanent impairment/damage.Based on the available information, the patient had required intervention to prevent permanent impairment/damage, 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 - 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: 25795834
• Report Number: 2953749-2026-02221
• Device Sequence Number: 5999525
• Product Code: NXC
• UDI-Device Identifier: 00816063020196
• UDI-Public: (01)00816063020196(10)0237291504(13)251023(91)2997335401N
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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): 07/13/2026

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: 237291504
• 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: 06/25/2026
• Initial Report FDA Received Date: 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2025
• 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: 36 YR
• Patient Sex: Female