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

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

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

Event Date 06/19/2023

Event Type  Injury  

Event Description

My daughter has used invisalign aligners since (b)(6) 2022.On her last tray she noticed a graying front tooth.Dentist has confirmed that the tooth has died due to trauma from the aligners.

• Brand Name: INVISALIGN ALIGNERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.
• MDR Report Key: 17203593
• MDR Text Key: 318000988
• Report Number: MW5118835
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 06/22/2023

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: 06/23/2023
• Patient Sequence Number: 1
• Treatment: MULTI VITAMIN
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 44 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White