MAUDE Adverse Event Report: SMILEDIRECTCLUB S.A. SMILE DIRECT CLUB ALIGNERS; ALIGNER, SEQUENTIAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/02/2023

Event Type  Injury  

Event Description

I used smile direct club for aligners to fix a tooth that was crooked due to crowding and ended up with negative results.They charged me (b)(6) for the service.After three rounds of aligners, the tooth is straightened but they messed up my bite so badly that i'm not able to close my teeth.My dentist said that i'm at risk of damaging/losing my front teeth because of the issue they caused.I've now started with a local orthodontist and i'm paying (b)(6) to fix the damaged they caused and it will take more than a year.Sdc is unwilling to provide a full refund and was unwilling to fix the issue that they caused (email proof).I can forward the pictures from the dentist, the emails with sdc as well as my ftc complaint.Thanks! (b)(6).

• Brand Name: SMILE DIRECT CLUB ALIGNERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): SMILEDIRECTCLUB S.A.
• MDR Report Key: 17070686
• MDR Text Key: 316677751
• Report Number: MW5118166
• 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: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/05/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White