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

Model Number INVISALIGN SYSTEM- LITE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

No conclusive evidence has been provided that supports or opposes the fact that the invisalign system aligners caused or contributed to the reported symptom.This event is being filed as an mdr as the patient lost a tooth and an align product may have contributed to the event.

Event Description

The patient reported the symptoms of pain on the upper right molar and a second root canal and extraction of upper left molar (#12).The patient reported having visited another dental provider, who performed a second root canal, due to the reported symptoms.It is unknown if the patient took or was prescribed any medication to alleviate the reported symptoms.The treatment was discontinued on (b)(6) 2020, but it unknown how the patient is currently doing.

• Brand Name: INVISALIGN SYSTEM
• Type of Device: SEQUENTIAL ALIGNERS
• 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: nestor vazquez ; 2820 orchard parkway; san jose, CA 95134 ; 4084701480
• MDR Report Key: 11497125
• MDR Text Key: 240124405
• Report Number: 2953749-2021-00731
• 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: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: INVISALIGN SYSTEM- LITE
• Device Catalogue Number: 8844
• Device Lot Number: 29316887
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2019
• 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): Disability
• Patient Age: 55 YR