MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC. SMILE DIRECT CLUB HOME ALIGNER; ALIGNER, SEQUENTIAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Date 10/09/2018

Event Type  Injury  

Event Description

I am an adult who always wanted to straighten her teeth.Recently i started seeing ads for at home aligner companies, smile direct club.My common sense told me that it was not a good idea, but i assumed if it was being allowed by the government to operate it was safe.After going through with the program, i started feeling a lot of changes to my bite.I tried to contact the company but they just dismissed everything.When i eventfully went to the dentist, he said that my bite has been damaged and now i will most likely be losing my upper front tooth from the force that has been placed on it.I am currently at loss, as i don't know where to go or what to do.I just can't believe that our government would not be protecting us from the corporation, preying on innocent people.I believed that the government agencies were above lobbies groups that will pay a lot of money to keep selling their product and to keep making more money.Of course, i don't have any resources to hire lawyers to fight them, and they know that, and this is how they keep getting away with it.If the government doesn't step in to protect us, who will.I will now be forever suffering the health consequences caused by them so they can profit off me.Please help.Fda safety report id# (b)(4).

• Brand Name: SMILE DIRECT CLUB HOME ALIGNER
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.
• MDR Report Key: 8649787
• MDR Text Key: 146469447
• Report Number: MW5086936
• 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: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2019
• 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): Required Intervention; Disability
• Patient Age: 55 YR
• Patient Weight: 61