MAUDE Adverse Event Report: SMILEDIRECTCLUB / ALIGN TECHNOLOGY, INC. ORTHODONTIA ; ALIGNER, SEQUENTIAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 02/02/2018

Event Type  Injury  

Event Description

I obtained aligners through smile direct club in (b)(6) 2018, after being furnished an ideal, corrected smile depiction in return for my home dental impressions and photographs.I was assured in writing my treatment would be overseen by an orthodontist in my state of residence, (b)(6).From the beginning of treatment (which i was told would conclude in 8 months), i experienced a number of problems, and contacted smile direct club about them.Chief among my complaints was difficulty chewing food.I was told this was a normal reaction to the realignment of my teeth and not cause for concern.I tracked down the orthodontist assigned to my case; he was dr (b)(6).I attempted to scheduled a trip to his office (four hours from my home) for an in-person consultation about the problems i was having, but was informed this was impossible.I contacted smile direct repeatedly, by phone and email.Their response was always the same: unless i was experiencing a great deal of pain, my difficulties were normal during orthodontic treatment.When my full set of aligners had been worn as prescribed and my "smile" was to have been corrected ((b)(6) 2018), my teeth were still not straightened and i had more trouble than ever chewing and digesting food.At this point, smile direct's response to my concerns was to schedule an appt for me at their (b)(6) "smile shop" for re-evaluation on (b)(6) 2018.I made that trip and their techs did some sort of imaging.I complained that i was unhappy with the progress of my case under dr (b)(6) supervision, and requested a new orthodontist.I had discovered, by this time, dr (b)(6) was born in (b)(6) and (b)(6) of age in 2018.After trying repeatedly to contact his (b)(6) "office", i began to wonder if he maintained an active practice of any sort.I also attempted to locate an office in (b)(6) for dr (b)(6), and found only that he was somehow licensed in the state in 2016.He has no (b)(6) office, despite smile direct's claim.About a month after that trip, i received a new set of aligners issued by "dr (b)(6)" (address unk).I believe they were about eight weeks' worth.One glance at the aligners showed the final set did not fit fully straightened teeth - i wore them religiously, anyway.Then i requested new aligners.I was sent an impression kit, asked for photographs, issued a new set.Throughout this time, i complained repeatedly about my bite and was told it was normal to experience difficulties until treatment was completed.I asked for and received aligners again, and was adamant i didn't want them to send me a set that resulted in anything less than straightened teeth, regardless of the number of sets they issued.Smile direct's response was to send another six weeks of aligners, along with a refund of (b)(6) and the promise of free retainers when my teeth were fully straightened.At each of these junctures, i had to keep wearing outdated aligners and wait through the lengthy process of smile direct issuing and shipping an impression kit, using and returning it immediately, then getting through an extremely extended period they took to create and mail new aligners.Despite my insistence, none of these sets of aligners resulted in straight teeth.They were better, mind you, but far from straight (and completely different from the animated "transformation" of my smile i'd been assured would occur).I gave up i settled, because i knew smile direct would continue sending me aligners in an endless cycle for years, but my teeth would never come close to the result they'd promised.My bite was still so messed up i couldn't chew properly, though, i am now being treated by a licensed orthodontist near my home for the problems caused by sdc.It boggles my mind that i have to take my dog to see a veterinarian and obtain a prescription for flea meds to be ordered online, but sdc is remodeling bone with no pt exams.Fda safety report (b)(4).

• Brand Name: ORTHODONTIA
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): SMILEDIRECTCLUB / ALIGN TECHNOLOGY, INC.
• MDR Report Key: 9207796
• MDR Text Key: 163005935
• Report Number: MW5090459
• 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: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR