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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMILE DIRECT CLUB LLC/ALIGN TECHNOLOGY SMILE DIRECT CLUB INVISIBLE ALIGNERS ALIGNER SEQUENTIAL

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SMILE DIRECT CLUB LLC/ALIGN TECHNOLOGY SMILE DIRECT CLUB INVISIBLE ALIGNERS ALIGNER SEQUENTIAL Back to Search Results
Event Date 10/01/2018
Event Type  Injury  
Event Description

I was approximately 3 months into a 5 month course of treatment with smile direct club orthodontic aligners when i noticed (1) that my teeth were not moving as they should have been and (2) two of my teeth became significantly loose. I sent photos and video to the company and they advised me to stay in my current aligner for 1 month to allow my teeth to stabilize. They did not, and i sent an additional video/photos at which time they told me to stop treatment and seek dental assistance. I requested a refund and i was told that i have to sign a release form to be refunded. The terms of that release form include that i cannot even mention the existence of the form, seek any additional compensation for damages and (this is most concerning) i could not share any information about my negative experience publicly. And if i had already posted anything in social media about my experience, i had to remove it before they would refund me. I feel that the company is very clearly trying to bias public opinion and hide any balanced information that implies their product may not work for everyone.

 
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Brand NameSMILE DIRECT CLUB INVISIBLE ALIGNERS
Type of DeviceALIGNER SEQUENTIAL
Manufacturer (Section D)
SMILE DIRECT CLUB LLC/ALIGN TECHNOLOGY
MDR Report Key8381753
Report NumberMW5084521
Device Sequence Number0
Product CodeNXC
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 02/27/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/28/2019
Is This An Adverse Event Report? Yes
Device Operator NO INFORMATION
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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