ORTHODONTIC ALIGNERS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-12 for ORTHODONTIC ALIGNERS manufactured by Align Technology.

Event Text Entries

[179447945] I started using smile direct's aligners in (b)(6) 2017. I was so excited to get started as i had always had crocked teeth but never could afford braces. Luckily, smile direct club, sdc, opened an office in my town, (b)(6), so i did not have to do impressions via mail. I had not been to the dentist in a while and had significant work previously done including crowns and caps. During my initial scan i mentioned that and you could easily see this on the scan. The tech didn't seem to think there would be any concerns. My treatment plan was relatively aggressive, i wore 2 aligners for 1 week each and then the next aligner in the series for 2 weeks. I complete my treatment in 6 months. Four months after my treatment was completed i began having pain in my jaw. One afternoon a tooth fell out forcing me to go to the dentist. While there i was surprised to learn that most of the work i had previously done had loosened and needed to be redone. This was now with (b)(6) worth of add'l work that i now needed. In the end, it was the recommendation of my dentist to get implants at (b)(6). When i reached out to sdc for a refund i was informed i was outside of their refund period, but they would review my case if i provided them with my dental records prior to treatment. They did not require dental records to start my treatment nor did they ask detailed questions about my prior dental health. Additionally, why would i spend (b)(6) on aligners to turn around and pay (b)(6) for implants? I believe i was either not a good candidate for their club or their negligence resulted in me losing my teeth. Sdc needs to be regulated and should require a dentist to oversee a pt while undergoing treatment. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5092970
MDR Report Key9706386
Date Received2020-02-12
Date of Report2020-02-10
Date of Event2019-07-01
Date Added to Maude2020-02-13
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameORTHODONTIC ALIGNERS
Generic NameALIGNER, SEQUENTIAL
Product CodeNXC
Date Received2020-02-12
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerALIGN TECHNOLOGY


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.