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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
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
MDR Text Key137795003
Report NumberMW5084521
Device Sequence Number0
Product Code NXC
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
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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