MAUDE Adverse Event Report: SMILE DIRECT / ALIGN TECHNOLOGY, INC. SMILE DIRECT ALIGNERS; ALIGNER, SEQUENTIAL

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/11/2020

Event Type  malfunction  

Event Description

I'm a victim of smile direct.It would've been more of a disaster if i didn't mention to my dentist that i was using their aligners.I'm cavity prone and smile never even recommended to me that i hold off until i see my dentist or orthodontist.Knowing that it could mess my teeth up even more but not telling me, they continue to take (b)(6) out of my account every month.It's scary that this company is still live and able to continue to ruin more people's lives.I've requested a refund from them but i have yet to hear from them.

• Brand Name: SMILE DIRECT ALIGNERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): SMILE DIRECT / ALIGN TECHNOLOGY, INC.
• MDR Report Key: 10114472
• MDR Text Key: 194053142
• Report Number: MW5094813
• 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: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 63