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

Model Number INVISALIGN FULL

Device Problem Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/01/2020

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 symptom of extraction of tooth #31 (lower right 2nd molar).It is unknown if the patient takes medications regularly or has any allergies and pre-existing conditions.It is unknown if the patient required medical intervention, medications were taken or prescribed, nor if laboratory tests were performed to alleviate the reported event.It is unknown if the patient is still wearing aligners or how the patient is currently doing.

• Brand Name: INVISALIGN SYSTEM
• Type of Device: SEQUENTIAL ALIGNER
• 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: 10817553
• MDR Text Key: 215537232
• Report Number: 2953749-2020-02914
• 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: 10/26/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: INVISALIGN FULL
• Device Catalogue Number: 8629
• Device Lot Number: 35927686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/21/2020
• 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: 37 YR