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

Device Problems Product Quality Problem (1506); Patient-Device Incompatibility (2682)

Patient Problem Sensitivity of Teeth (2427)

Event Date 12/31/2019

Event Type  Injury  

Event Description

I went to dr.(b)(6) on (b)(6) 2019 to sign financial forms for invisalign treatment at the office on (b)(6).I went back on (b)(6) 2019, to get my molds done.I paid (b)(6) and insurance was to pay (b)(6).I went back on/around (b)(6) 2020 for tooth extraction, and they told me my trays had arrived.My treating doctor, (b)(6) couldn't do the extraction.I had to come back to let another doctor do that.I am not sure why.I let them put on my attachments, and they gave me the trays.I was told by (b)(6), the dental assistant to wear them every 2 weeks and wash them with antibacterial soap, not toothpaste, and she sent me out the door.On (b)(6) 2020 (b)(6) and (b)(6) in the office handed me an invisalign informed consent form to sign.When i read it, i knew that i wasn't going to be happy with my results because i went and looked into the mirror.I was going to have a great big black triangle in front of my bottom teeth.I didn't realize that was going to happen before reading the form.I felt pressure to sign the form and continue and wrote them an email saying i was not happy.I sent many emails.I knew it was going to cost me more and more money and they knew that and didn't tell me.After that, i didn't trust them anymore because when i asked them what they were going to do about the triangle, (b)(6) suggested bonding.This was not the best treatment.Dr.(b)(6) didn't seem to have an opinion.I was so concerned.I fired this doctor, who i now don't believe was not qualified to treat me, and went to find treatment elsewhere, but it was too expensive or they wanted to transfer treatment.I no longer wanted to do invisalign.I contacted invisalign who emailed me and told me that they only fill a prescription written by a doctor for the trays in the lab and they have no liability.How can they fill a prescription for a medical device without requiring someone sign for informed consent? i wore the trays for another couple of months trying to find another doctor.I had to stop because i couldn't breathe well anymore, and i felt like my throat was closing up on me.I took them out.I now have attachments still stuck to my teeth and my teeth have shifted back crooked.I know they have screwed me, and i'm not going to be able to get treatment without paying (b)(6) dollars more to a real orthodontist, but i want you to know that they are withholding informed consent and taking people's money in this office to make money off invisalign.The ladies in this office made up lies about me and attacked me personally because of their wrongdoing.For the record, i have not ever been a drug addict or a child abuser.Here's a link to my (b)(6) so you can see who i am.(b)(6).I memorize the holy bible in my spare time.There are videos of me doing that there.My daughters are (b)(6) and (b)(6) and wonderfully successful.Those people are liars.Please make these doctors give informed consent to other patients.Invisalign should not be allowed to fill a prescription for their trays and send it to a doctor without having a fully signed informed consent form or perhaps some form of informed consent training telling patients of the risk and potential extra cost.I had so many problems with this office and i can't fit it all in this form, but i was denied informed consent.They knew what they were doing and you need to make sure that these people are informing their patients.Please do not allow invisalign to fill prescriptions written by dentists for a medical device without also requiring informed consent.These have too much power to take patients' money and not inform them of the risk.I don't have a doctor now, my reputation has been destroyed, i have attachments stuck on my teeth, and i can't breath good.They have taken my money, withheld consent.Please hold them accountable.If you can't help me perhaps you can make the rules that make sure that this doesn't happen to anyone else.Please don't let them get away with ripping people off for money and causing harm to them.I have a copy of my informed consent form, email exchanges, and financial forms if you need them email me.Fda safety report id # (b)(4).

• Brand Name: INVISALIGN
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.
• MDR Report Key: 10810568
• MDR Text Key: 215608541
• Report Number: MW5097709
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): Y
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 79