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

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

Patient Problem Pain (1994)

Event Date 04/28/2023

Event Type  Injury  

Event Description

I was flossing and my crowned tooth fell out.4 months prior i complained about severe pain from invisalign retainer.I was told to be gentle in this area but also to keep the invisalign on at all times of day including eating.I tried, but it was too painful in this area.Months later i was flossing and this tooth fell out.I have an email to the dentist complaining about this tooth pain.

• Brand Name: INVISALIGN RETAINERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.
• MDR Report Key: 16963226
• MDR Text Key: 315735799
• Report Number: MW5117721
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/16/2023

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/18/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Race: Asian