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

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 02/12/2022

Event Type  malfunction  

Event Description

I signed up to use smile direct club's retainers to straighten my teeth.The retainers were of such poor quality that they never did the job and the last set i received wouldn't even stay in my mouth.At no point in the process was a i given the opportunity to speak to a.Dentist about my concerns and, after emailing them repeatedly, they have stopped responding to me altogether and have not done a thing to resolve the problem.There is no way this company should be allowed to sell this product in the united states.They are not using proper discernment in who they are doing business with when it's clear their product isn't going to be effective.Their customer service people are not dentists and they should not be serving as go-betweens, because the number of problems i've had over the years are clearly not being relayed back to a dentist.I can't imagine any dentist who is serious about their work would permit people to waste years using a product that they can clearly see isn't having an impact on their teeth.This entire process has been an unethical failure.Fda safety report id#:(b)(4).

• Brand Name: SMILE DIRECT CLUB ALIGNERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): SMILE DIRECT, LLC./ ALIGN TECHNOLOGY, INC.
• MDR Report Key: 13846183
• MDR Text Key: 287792708
• Report Number: MW5108359
• 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: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Hispanic
• Patient Race: White