MAUDE Adverse Event Report: SMILEDIRECTCLUB S.A. ORTHODONTIC ALIGNERS; ALIGNER, SEQUENTIAL

Device Problem Product Quality Problem (1506)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 07/27/2021

Event Type  Injury  

Event Description

Purchased treatment from smiles direct club for aligners to fix a crossbite.First treatment was supposed to be between 14 and 16 weeks.Reported to sdc around (b)(6) 2020 that there were issues with the fit.Was told to just continue wearing them; this was normal.After several conversations back and forth, they finally agreed to redo the aligners on (b)(6) 2020.I started the second series of aligners but as each week progressed, the aligner fit was becoming tighter and more painful.Again i was told to just continue wearing them.Around (b)(6) 2021 i lodged another complaint about the aligner fit because i was no longer able to get the aligners to fit onto my teeth after week 8 or 9, they were literally so far off from the shape of my teeth at that point because my teeth simply were not moving.I was essentially being told to shove week 9's aligner set in, with my teeth still being in week 1 position.Finally they agreed to review and see if i needed a "touch up" again.I let them know that this was not a touch up, that my teeth had literally not moved since starting the treatment.They approved another series of aligners.Early (b)(6) 2021, i started noticing the same issue with the third series of aligners.Each week the aligners were more difficult to insert, and were increasingly tight and excruciatingly painful.I reported this to sdc again and again was told to just continue wearing them, some pain and discomfort was normal.I advised them this kind of pain was not normal, and sent pictures of how the aligners were not even seated on my teeth fully.To insert them, my teeth were actually reshaping the aligners instead of the other way around.I was concerned that we were possibly damaging my teeth by smashing them together in increasing amounts of pressure.My teeth were very obviously not moving but after reviewing the photos, they insisted i was progressing and to keep wearing them.I finally reached a point where again the aligners would not fit over my teeth without bending them.As a test, i put the very first set in that i had in the series and found that the first aligner set fit perfectly, an obvious indication that my teeth had never moved and i had just been cramming these aligners onto my teeth with not only zero results, but with increasing force.I again contacted them and they wanted to do another "touch up", however i refused and demanded a refund instead, on the basis that they either had improperly screened me and i was not in fact a good candidate for their solution, or that they were just too incompetent to design the aligners correctly to accomplish what was needed for success.They would only approve a partial refund because i only had 2 unopened sets left and was outside the 30 day return policy.I advised that i would report them to all related agencies and would be filing suit against them for the entire balance.Fda safety report id# (b)(4).

• Brand Name: ORTHODONTIC ALIGNERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): SMILEDIRECTCLUB S.A.
• MDR Report Key: 12275566
• MDR Text Key: 265201784
• Report Number: MW5102965
• Device Sequence Number: 1
• Product Code: NXC
• 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: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• 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 Age: 51 YR
• Patient Weight: 84