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

Model Number ADDITIONAL ALIGNERS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Chest Pain (1776); Headache (1880); Vertigo (2134)

Event Date 03/01/2019

Event Type  Injury  

Manufacturer Narrative

No conclusive evidence has been provided that supports or opposes that fact that the invisalign system aligners caused or contributed to the patients symptoms.This event is being filed as an mdr as the patient reported chest pain while an align product was being used.

Event Description

The patient reported symptoms of chest pain, shortness of breath, panic attacks, vertigo, headaches and speech difficulties.The patient did not report requiring any medical intervention to alleviate the reported symptoms.The patient did not report taking or being prescribed any medication to alleviate the reported symptoms.The treatment has not been discontinued as the patient is still wearing the aligners.

• Brand Name: INVISALIGN SYSTEM
• Type of Device: SEQUENTIAL ALIGNER
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.; 2820 orchard parkway; san jose CA 95134
• Manufacturer Contact: ryan hoffmeister ; 2820 orchard parkway; san jose, CA 95134
• MDR Report Key: 8495887
• MDR Text Key: 141345137
• Report Number: 2953749-2019-00736
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ADDITIONAL ALIGNERS
• Device Catalogue Number: 8629
• Device Lot Number: 27815656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR