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

Model Number	INVISALIGN FULL
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Vertigo (2134)
Date of Event	09/01/2023
Type of Reportable Event	Serious Injury
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 patient reported that the chiropractor had indicated the aligners may have caused the patient's equilibrium to be 'out' (as reported by the patient).Align's clinical assessment includes the following: from the primary order records, it is evident that the patient had pre-existing condition of a dolichofacial face with significant increase of the patient's vertical dimension, the patient also had anterior contacts and lack of overjet and overbite.No recent photos or x-rays were provided to analyze the current vertical dimension and clinical condition changes, however on latest scan from (b)(6) 2022 the initial position bite shows an improvement of the overjet and overbite which indicates an occlusal change with better interocclusal contacts, no anterior contacts and more aligned teeth and arch forms.Changes in the occlusion and vertical dimension can modify the condyle position and movements between the temporo-mandibular articulation.No conclusive evidence has been provided that supports or opposes the fact that the invisalign system aligners caused or contributed to the reported symptoms of vertigo and the patient outcome of hospitalization.This event is being filed as an mdr as the patient reported hospitalization and an invisalign product was being used.
Event or Problem Description
The patient directly reported the following: patient reported symptom of vertigo, which led to hospitalization in (b)(6) 2023.The treating doctor shared that they were unaware of the patient's reported symptoms.The patient reported requiring hospitalization in (b)(6) 2023 and visiting a chiropractor in (b)(6) 2023 to alleviate the reported symptom.The patient reported taking anti-nausea medication at the hospital (which caused the patient to throw up) to alleviate the reported symptom.It is unknown if the patient is still wearing the aligners.

• 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: harper shore ; 3030 slater road; morrisville, NC 27560 ; 4084701343
• MDR Report Key: 18567049
• Report Number: 2953749-2024-00003
• Device Sequence Number: 18173715
• Product Code: NXC
• UDI-Device Identifier: 00816063020004
• UDI-Public: (01)00816063020004(10)0134889142(13)221121(91)06661413XXN
• Combination Product (Y/N): N
• PMA/510(K) Number: K220287
• 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): 01/23/2024

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: 134889142
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2023
• Initial Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2022
• 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: 41 YR
• Patient Sex: Male