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

Device Problem Fitting Problem (2183)

Patient Problems Headache (1880); No Code Available (3191)

Event Date 11/22/2019

Event Type  Injury  

Event Description

I started using smile direct¿s aligners in (b)(6) 2018.I was so excited to get started as i had always had ¿croked¿ teeth but never could afford braces.Luckily, smile direct club, sdc, has an office in my town, (b)(6) so i did not have to do impressions via mail.During my consultation, i did inquire about having my wisdom teeth, but was reassured if there was an issue with having them i would be informed.The first few trays fit nicely and my teeth moved as they should.After about the third tray i noticed some issues with how the trays were fitting and began reaching out to sdc customer service.Their customer service team assured me the fit was fine and to continue to wear them as instructed.Towards the end of my first course the trays were too tight and i complained i felt my wisdom teeth were the problem.I was not instructed to consult with my dentist, nor was i advised my wisdom teeth could be the problem.The customer service rep scheduled a rescan which i completed.While at the rescan i brought my wisdom teeth up again, and once more was reassured that if my wisdom teeth were a problem home office would advise.It was not until my last mid-course correction, (b)(6) 2019, sdc finally agreed my wisdom teeth were the problem.At this point the alignment of my teeth are severely out of alignment based on how they were trying to ¿straighten¿ my teeth.If you compare the photos over time, you can see my alignment got worse over time, they kept trying to force my teeth straight even though there was not even room in my mouth for my teeth to be straight.My dentist commented i could have lost all of my teeth had they continued, or their negligence could have loosened existing dental work.In the end i have had to have my wisdom teeth removed to make room for my teeth to move, but suffered with ¿unexplained¿ pressure in my jaw that resulted in several migraines i now realize is from their treatment plan.I have stopped using my sdc aligner at the advice of my dentist and oral surgeon.When i attempted to discuss my concerns and the advice my dentist was giving me with sdc i was informed i could not speak directly with my dental professional that approves my treatment plan.Their structure is setup is such a complex way i must relay my questions thru someone to relay to the dental professional relay back to me.My teeth are now severely out of alignment and my dentist refuses to work on my teeth while i am under the care if sdc.My bite is not lined up either and i cannot chew properly either.Sdc needs to be regulated and should require a dentist to oversee a patient while undergoing treatment.They do not require a dental evaluation prior to either which i see is a problem.

• Brand Name: ORTHODONTIC ALIGNER
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): SMILE DIRECT CLUB/ALIGN TECHNOLOGY, INC.
• MDR Report Key: 9693834
• MDR Text Key: 179313892
• Report Number: MW5092895
• 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: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• 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): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 86