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

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

Event Date 02/09/2024

Event Type  Injury  

Event Description

I started invisalign treatment in (b)(6) of 2023 and less than 3 months later i suffered from tooth resorption- i have never had any oral health problems previously.My regular dentist told me this was likely from invisalign ((b)(6) 2024).On (b)(6) 2024 i went for my ortho (orthodontist) appointment and inquired about potential treatment modifications to avoid further deterioration or a refund.The practitioner was defensive and told me he didn't think my issue was from poor hygiene but also didn't agree it was from invisalign- even though my regular dentist brought this to my attention, and i can see it has happened to other people from my own internet research.I was not properly informed of these risks.Additionally, the practitioner stated he wouldn't recommend any modifications except for 1.Standard braces (which still carry risk of resorption) or 2.Pausing for 4 months - which i'm not sure what that would accomplish (?) no explanation was given for the recommendation to pause.Tomorrow (b)(6) 2024 i need to have additional dental work as a result of the deterioration have experienced from the invisalign device.Again, i never had any oral health or hygiene issues prior to invisalign.I used the trays as directed.

• Brand Name: INVISALIGN TRAYS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.
• MDR Report Key: 18799513
• MDR Text Key: 336566489
• Report Number: MW5152098
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native