MAUDE Adverse Event Report: STRAIGHT SMILE, LLC BYTE INVISIBLE TEETH ALIGNERS; ALIGNER, SEQUENTIAL

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Pain (1994); Sensitivity of Teeth (2427)

Event Date 10/19/2020

Event Type  Injury  

Event Description

I first submitted my impression kit for teeth aligners in the middle of november because i had a small cosmetic fix for my teeth.I previously had braces and wore my retainers religiously but i felt that the retainers had lost their shape a bit and wanted to get some invisible aligner to correct the issue.During this time they had employees texting me in order to guide me through the process, but i never spoke to an actual orthodontist at all throughout this entire experience.They received it and a couple of days later, someone contacted me about purchasing the treatment plan before it was finished in order to "speed up" their manufacturing process.I felt like that was a little fishy and said i would wait until i saw the treatment plan before purchasing.When i looked at the plan, i had a few concerns because the problem area was on my right side while the 3d plan showed most of the teeth moving on the left side.This led me to message my "personal byte advisor" but he just advised me that i was looking at the plan incorrectly and everything would be how i wanted with the right side moving.So listening to his reassurance, i purchased the aligners but when i received them in the mail and tried them for a week i could already tell that my concerns, in the beginning, were correct and the teeth were indeed moving in a way i did not want.Now my left top and bottom teeth are scraping each other every time i chew and caused lots of sensitivity and pain.I tried reaching out to the company to be refunded but they refused because they said i reviewed the plan and purchased it.But i only purchased it because their employee misled me to believe that my concerns weren't valid.Now they are urging me to finish the treatment saying they "guarantee a smile for life" so if i'm unhappy with the results i can just get more things done.But i don't feel comfortable completing the treatment because when i reviewed it, i wasn't happy with it to begin with and i'm unwilling to complete this treatment and then start other treatment when i'm unhappy with it.The company should have got it correct on the first try or told me that the treatment plan was indeed moving the left side as i stated in my concerns and i would not have purchased it.They are having unsafe business practices causing many clients to mess up their teeth and have to be fixed with other methods.Fda safety report id # (b)(4).

• Brand Name: BYTE INVISIBLE TEETH ALIGNERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): STRAIGHT SMILE, LLC
• MDR Report Key: 10770386
• MDR Text Key: 214360358
• Report Number: MW5097596
• 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: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• 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 Age: 23 YR