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

Patient Problem Tooth Fracture (2428)

Event Date 12/05/2023

Event Type  Injury  

Event Description

Invisalign caused my right front tooth to crack.

• Brand Name: INVISALIGN RETAINERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.
• MDR Report Key: 18302795
• MDR Text Key: 330273233
• Report Number: MW5149075
• 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: 12/06/2023

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American