ORTHODONTIC ALIGNER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-10 for ORTHODONTIC ALIGNER manufactured by Smile Direct Club/align Technology, Inc..

Event Text Entries

[179313892] I started using smile direct? S aligners in (b)(6) 2018. I was so excited to get started as i had always had? Croked? Teeth but never could afford braces. Luckily, smile direct club, sdc, has an office in my town, (b)(6) so i did not have to do impressions via mail. During my consultation, i did inquire about having my wisdom teeth, but was reassured if there was an issue with having them i would be informed. The first few trays fit nicely and my teeth moved as they should. After about the third tray i noticed some issues with how the trays were fitting and began reaching out to sdc customer service. Their customer service team assured me the fit was fine and to continue to wear them as instructed. Towards the end of my first course the trays were too tight and i complained i felt my wisdom teeth were the problem. I was not instructed to consult with my dentist, nor was i advised my wisdom teeth could be the problem. The customer service rep scheduled a rescan which i completed. While at the rescan i brought my wisdom teeth up again, and once more was reassured that if my wisdom teeth were a problem home office would advise. It was not until my last mid-course correction, (b)(6) 2019, sdc finally agreed my wisdom teeth were the problem. At this point the alignment of my teeth are severely out of alignment based on how they were trying to? Straighten? My teeth. If you compare the photos over time, you can see my alignment got worse over time, they kept trying to force my teeth straight even though there was not even room in my mouth for my teeth to be straight. My dentist commented i could have lost all of my teeth had they continued, or their negligence could have loosened existing dental work. In the end i have had to have my wisdom teeth removed to make room for my teeth to move, but suffered with? Unexplained? Pressure in my jaw that resulted in several migraines i now realize is from their treatment plan. I have stopped using my sdc aligner at the advice of my dentist and oral surgeon. When i attempted to discuss my concerns and the advice my dentist was giving me with sdc i was informed i could not speak directly with my dental professional that approves my treatment plan. Their structure is setup is such a complex way i must relay my questions thru someone to relay to the dental professional relay back to me. My teeth are now severely out of alignment and my dentist refuses to work on my teeth while i am under the care if sdc. My bite is not lined up either and i cannot chew properly either. Sdc needs to be regulated and should require a dentist to oversee a patient while undergoing treatment. They do not require a dental evaluation prior to either which i see is a problem.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5092895
MDR Report Key9693834
Date Received2020-02-10
Date of Report2020-02-07
Date of Event2019-11-22
Date Added to Maude2020-02-11
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 ALIGNER
Generic NameALIGNER, SEQUENTIAL
Product CodeNXC
Date Received2020-02-10
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerSMILE DIRECT CLUB/ALIGN TECHNOLOGY, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-10

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