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

Model Number INVISALIGN ASSIST

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pneumonia (2011); Vertigo (2134)

Event Date 08/01/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 324176447
• Report Number: 2953749-2023-02709
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00816063020080
• UDI-Public: (01)00816063020080(10)0153261456(13)230614(91)20808606XXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female