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

Model Number	9002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nausea (1970); Vomiting (2144); Dizziness (2194); Shaking/Tremors (2515); Speech Disorder (4415)
Date of Event	02/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The current instructions for use (ifu) contains the following: "precautions, in rare instances, some patients may be allergic to the plastic aligner material.", "the product may temporarily affect speech and may result in a lisp, although any speech impediment associated with the product usually disappears within one or two weeks." no conclusive evidence has been provided that supports or opposes whether the invisalign system aligners caused or contributed to the required hospitalization (initial or prolonged), therefore, this event it is being filed as an mdr per 21 cfr 803.
Event or Problem Description
The treating doctor reported the patient presented dizziness, nausea, vomiting, tremors and speech problems.Patient was hospitalized for 4 days.Medical intervention and symptoms happened on (b)(6) 2025.The patient stopped the use of the product and by now the patient is getting better.
Additional Manufacturer Narrative
Additional information provided on (03/28/2025): the patient is now feeling better.The patient is still experiencing some symptoms; however, the treating doctor has excluded any connection with the aligners.There were no abnormalities found in any of the testes performed.There was no test result that suggest a possible allergic reaction or intolerance to the product.

• Brand Name: INVISALIGN SYSTEM - LITE
• 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 parway; san jose, CA 05134
• MDR Report Key: 21547316
• Report Number: 2953749-2025-00486
• Device Sequence Number: 7133569
• Product Code: NXC
• UDI-Device Identifier: 00816063020202
• UDI-Public: (01)00816063020202(10)0207463496(13)250107(91)2650763301N
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K241412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2025

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: 9002
• Device Lot Number: 207463496
• 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: 02/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 04/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2025
• 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: 54 YR
• Patient Sex: Female