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

Model Number INVISALIGN SYSTEM - COMPREHENSIVE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 03/01/2020

Event Type  Injury  

Manufacturer Narrative

No conclusive evidence has been provided that supports or opposes that fact that the patient aspirated a piece of an invisalign system aligner.This event is being filed as an mdr as this event appears to have been serious in nature to the patient.

Event Description

The patient reported swallowing a piece of the aligner.The patient reported visiting the hospital, and was sedated to have their lungs examined by a bronchoscopy.During the examination scratches were found in the lungs, but the aligner piece was not found.The patient did not report requiring any medical intervention to alleviate the reported symptom.The treatment was discontinued on (b)(6) 2020.

• Brand Name: INVISALIGN SYSTEM
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.; 2820 orchard parkway; san jose, ca
• Manufacturer Contact: ryan hoffmeister ; 2820 orchard parkway; san jose, ca ; 7891588
• MDR Report Key: 9960457
• MDR Text Key: 190775143
• Report Number: 2953749-2020-01080
• 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: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: INVISALIGN SYSTEM - COMPREHENSIVE
• Device Catalogue Number: 8812
• Device Lot Number: 32075383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2019
• 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: 8 YR