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

Device Problems Fracture (1260); Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Date 12/06/2022

Event Type  Injury  

Event Description

I was told i am a good candidate for invisalign by my orthodontist.I have tmj(temporomandibular joint disorder) and multiple crowns, implants and a bridge.I have had tooth and jaw pain since i started and my tmj has increased.In (b)(6) 2022 one of my crowns fractured.After spending (b)(6) on invisalign i now have to spend (b)(6) on a crown.I am sure there will be more repair required until i finish wearing them (i have been wearing them since (b)(6) 2021.Reference report #mw5115771.

• Brand Name: INVISALIGN ALIGNERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.
• MDR Report Key: 16552219
• MDR Text Key: 311489670
• Report Number: MW5115770
• 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: 03/13/2023

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: 03/15/2023
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Race: White