MAUDE Adverse Event Report: INVISALIGN; ALIGNER, SEQUENTIAL

Device Problem Use of Device Problem (1670)

Patient Problem Tooth Fracture (2428)

Event Date 08/30/2022

Event Type  Injury  

Event Description

I have two very large cracks in my teeth (2 separate teeth) after invisalign treatment.I haven't had a problem prior.These cracks are across the whole teeth and reach the gum line.

• Brand Name: INVISALIGN
• Type of Device: ALIGNER, SEQUENTIAL
• MDR Report Key: 17240214
• MDR Text Key: 318297430
• Report Number: MW5119038
• 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: Patient
• Type of Report: Initial
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 49 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White