MAUDE Adverse Event Report: SMILEDIRECTCLUB, LLC CLEAR MOUTH/TEETH ALIGNERS; ALIGNER, SEQUENTIAL

Device Problems Malposition of Device (2616); Material Deformation (2976)

Patient Problem Discomfort (2330)

Event Date 08/04/2018

Event Type  Injury  

Event Description

I started my smiledirectclub journey (b)(6) 2017 with my first set of retainers.It was a breeze.Each month, for a total of 8 months, i had 3 different sets of retainers; week one, week two, and weeks 3-4.I didn't notice any issues until month 8, week 3 where my teeth were straight, yes, but i could not touch any of my back teeth.I wrote an email on ((b)(6) 2018) to smiledirectclub letting them know that my bite was off.They replied with wanting me to send pictures and a detail of what teeth were involved.I replied with 10 pictures of what was wrong and a detailed note that explained which teeth were "nothing" me and where my bite was off.The note said "my bite is off because teeth 11 and 22 and 6 and 27 all interfere with each other.Teeth nos.22 and 27 prevent all molars from touching each other.Tooth #23 is also crooked still, it has a gap between 22/23.When i wear the aligners (month 8, weeks 3 and 4, which started (b)(6) 2018) all my teeth touch, it's when i take them out to eat and drink that my teeth do not connect." the team replied back saying: "my name is (b)(6), a member of the dental team here at smile direct club.Thank you so much for letting us know about the concerns you are having with your bite.I have reviewed the photos that you have sent us and we would recommend you see your local dentist for an occlusion equal abrasion.This is a painless procedure where they will adjust your bite to its normal state." i went to my dentist to have this procedure done.I had to have my teeth shaved down in order to bite properly again.My dentist told me this could have been very bad if i hadn't made these adjustments.I again went home to write yet another email to smiledirectclub stating how frustrated i was that i had to shave down perfectly healthy teeth in order to eat/chew properly.I also complained about my midline because even though my teeth were crooked, my midline was still straight.Their reply: "thank you for reaching out to our team with your concerns.I have reviewed your case and your smile plan and in your completed smile plan that you received when starting treatment, i do see that your mid-line was predicted to be that way.As far as your bite, because this is a remote clear aligner therapy where we do not place or provide attachments as we are a remote company and attachments require chair-side monitoring along with office visits, we do not correct your bite.We focus on the alignment of your teeth which is shown in your smile plan." this made me more angry because i had no idea that using smiledirectclub would further ruin my mouth "then" fix it.They are misleading in their treatment and the clients are left unhappy, and in my case, i now need orthodontics because it is so uncomfortable to bite and eat/chew.

• Brand Name: CLEAR MOUTH/TEETH ALIGNERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): SMILEDIRECTCLUB, LLC
• MDR Report Key: 8074762
• MDR Text Key: 127588870
• Report Number: MW5081315
• 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: 11/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 66