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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Deformity/ Disfigurement (2360)

Event Date 12/13/2018

Event Type  Injury  

Event Description

This pt underwent orthodontic therapy with (b)(6).It is my assessment as an orthodontic professional that a medical device is being prescribed to straighten her teeth without being under the supervision of a trained dentist / orthodontist.She was charged $2000 for a service that left her teeth crocked, the heights of her front teeth are completely uneven, the back teeth do not come together properly and several of those teeth are interfering with each other, and the supposed "doctor" diagnosing and assisting with this case left 2 unerupted permanent teeth under the gumlines and existing baby teeth on a (b)(6) y/o girl.(b)(6) also failed to alert the pt that she is also missing 2 permanent teeth, and in one instance, the remaining baby tooth is submerging down below the level of all the adjacent teeth, causing the bite to be even worse.All of this is visible in the photos and x-rays provided.A first year dental student would know to not leave permanent teeth in the jawbone without offering treatment options, and they would also know that at age (b)(6), all baby teeth should have fallen out, thus extractions of all but 2 primary teeth would have been necessary and appropriate treatment.This pt is actually worse off now, than when she started.She now has to seek re-treatment in my office and under my direct care.Had (b)(6) done more than just mail her some plastic trays, she could have had a nice result and not wasted her money.They never told her about her impacted permanent teeth, nor offered any options that could have better suited her actual needs.A case like this, treated by a board certified orthodontist would take 24-30 months to correct using braces on the teeth, so offering someone a 6 month treatment with plastic trays to correct complex problem is like offering me a screwdriver to hammer a nail into a wall, it's the wrong tool for the job.Unfortunately, (b)(6) is actually practicing without a license and offers no supervision of the case.I do not believe she was offered any options to continue her treatment, alternative to their prescribed treatment, or retainers to hold her teeth in position.They state in their press releases that 750,000 pts have been successful treated, but offer no measure by which these cases have been evaluated.If this pt shown here is a success, then it is no wonder they have come up with that number.What we sadly see more commonly, is pts are biked out of $2000 and more often than not left with incomplete orthodontic care and no options or recourse.Please see the attached photos and x-rays that depict the final "successful" result of this pt's treatment.Clearly it is below the standard of care for any dental professional and thus this pt should be entitled to a refund at a minimum and legal recourse ideally.Fda safety report id# (b)(4).

• Brand Name: SMILE DIRECT CLUB
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): SMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC. ; nashville TN 37219
• MDR Report Key: 9218774
• MDR Text Key: 163563520
• Report Number: MW5090525
• 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: Dentist
• Type of Report: Initial
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16 YR