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

Patient Problems Abrasion (1689); Pain (1994); Speech Disorder (4415); Increased Sensitivity (4538)

Event Date 07/17/2023

Event Type  malfunction  

Event Description

I started with the at home impression kit.They needed me to redo it, so i wanted to go to a smile shop instead so that the 3 d scan would be more accurate and avoid any complications from me attempting to do the impression kit myself.The smile shops are about an hour away from my house.There was finally a pop-up smile shop in my town, so i went in (b)(6) 2022.The consultant showed me how my teeth would look with the digital treatment plan progression.My top teeth were already straight.My bottom front teeth were crowded.The digital progression photos showed straight bottom front teeth.My initial treatment plan was listed as 8 months of nighttime wear for 10 hours per night with each set of aligners worn for 2 weeks.I received my first set of aligners in (b)(6) 2022.I wore them as prescribed.I neared the end of my treatment program when i was unable to wear the bottom aligner in the next set because they wouldn't fit.I would have had to use force to make it fit over my bottom teeth because the aligner didn't line up with how my teeth were positioned.I drove 45 miles to a smile shop and have a new 3 d scan after obtaining approval from my dentist, dr.Danny blaine leeds.I received a new treatment plan and new set of aligners in (b)(6) 2022.That was when my first treatment plan was supposed to be complete.The new treatment plan was another 8 months.I was supposed to complete it in (b)(6) 2023.I paid for another 8 months of aligners.I understand that every case is different, so i was willing to shell out more money i hadn't originally planned to spend because i believed them when they said this treatment would work and that it would work as well as their competitor, invisalign.Things started off fine.However, the aligners of the new treatment plan started making my teeth hurt when i removed them.I had to wait 1-2 hours before eating because my mouth was sore.I was also getting abrasions on the insides of my cheeks and having to file down the aligners so they wouldn't cut or dig into my gums because they went to the level of my gumline.The aligners made me speak with a lisp, which i was told during the consultation that wouldn't happen if they fit properly.I wore the aligners until i was unable to fit the bottom set onto my teeth yet again.The aligner didn't fit or line up with my bottom teeth, which were still just as crooked as when i started the treatment plan.I was told to wear the last set of aligners that did fit for a couple more weeks.That didn't work.My treatment plan was scheduled to end in (b)(6) 2023.When i visited my dental hygienist at the end of (b)(6) 2023, she was shocked when i told her i was almost done with the second treatment plan because my bottom teeth were still very crowded.I reached out to their customer service department and was told to send in photos and a detailed explanation of my concerns.I did that twice and received no response.Finally, upon submitting my photos and complaints a third time, i was approved for a second aligner touchup session.Sdc wanted me to purchase retainers when i finished the treatment plan, but i expressed how i wasn't sure how i was supposed to do that considering 1.I was unsatisfied with my "end" results and 2.I wasn't even able to wear the last 2 sets of aligners, so i didn't know how they thought the retainer would even fit properly.Purchasing the retainer is the only way that one can qualify for their "lifetime smile guarantee".I have now been approved for a third treatment plan of another 8-10 months, at my own expense of course.I could have gotten traditional braces if i was going to have to deal with this for over 2 years.I feel like i paid for a service that promised results but didn't deliver.(b)(4) after several requests via phone and email.N/a no medical test performed.Reference report: #mw5146644.

• Brand Name: TEETH ALIGNERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): SMILEDIRECTCLUB S.A
• MDR Report Key: 17885540
• MDR Text Key: 325502278
• Report Number: MW5146645
• 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: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American