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

Model Number	INVISALIGN ASSIST
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pneumonia (2011); Vertigo (2134)
Date of Event	08/01/2023
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 potential root cause is unknown.After multiple attempts to obtain additional information about this event, the reason for hospitalization remains unknown.No conclusive evidence has been provided that supports or opposes the fact that the invisalign aligners caused or contributed to the reported event (involving hospitalization).This event is being filed as an mdr as the patient reported the admittance to the hospital, and an invisalign product was being used.
Event or Problem Description
The treating doctor reported that the patient had symptoms of vertigo after starting the invisalign treatment, developed pneumonia and is very sick.The patient reported requiring admittance to the hospital.It is unknown if the patient required medications to alleviate the reported symptoms.The patient reported discontinuing the use of the aligners (date unknown); however, no progress has been reported to the dental office yet.

• 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: 17810916
• Report Number: 2953749-2023-02709
• Device Sequence Number: 15240511
• Product Code: NXC
• UDI-Device Identifier: 00816063020080
• UDI-Public: (01)00816063020080(10)0153261456(13)230614(91)20808606XXN
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2023

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 ASSIST
• Device Catalogue Number: 8534
• Device Lot Number: 153261456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2023
• 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: 75 YR
• Patient Sex: Female