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

Model Number	INVISALIGN FULL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Headache (1880)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported that the aligner treatment made the patient's migraines worse in 2020 and reported being hospitalized.No additional information is available at this time.
Additional Manufacturer Narrative
The current instructions for use (ifu) 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 noted that the orthodontic treatment began in 2017, during which an acceleration device was used.In 2018, the patient reported headaches.The patient, last visit to the office was in 2021 and has not been in contact with the patient since despite follow-up attempts.The patient required hospitalization due to migraines, and the invisalign system aligners were being used, and therefore this event is being filed as an mdr per 21 cfr 803.There is no conclusive evidence to confirm the exact date of the hospitalization except that it was during 2020.

• Brand Name: INVISALIGN SYSTEM
• 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: adriana solis ; 2820 orchard parkway; san jose, CA 95134
• MDR Report Key: 20864140
• Report Number: 2953749-2024-03341
• Device Sequence Number: 8688210
• Product Code: NXC
• UDI-Device Identifier: 00816063020004
• UDI-Public: (01)00816063020004(10)0025073578(13)170416(91)05731761XXN
• Combination Product (Y/N): N
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2024

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: INVISALIGN FULL
• Device Catalogue Number: 8500
• Device Lot Number: 25073578
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2017
• 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