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

Device Problems Product Quality Problem (1506); Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Swelling/ Edema (4577)

Event Date 12/12/2022

Event Type  Injury  

Event Description

Smile direct aligners caused injury to my daughter.Pain and swelling and bleeding to gums from improper fit and production.Made a gap in her teeth that wasn't previously there.Not one set of aligners fit right and they all were sharp and ridged she could barley chew her food pain was so bad.This was all documented and verified by her dentist who said the product was not produced right and causing her issues.They gave me a file and wax to fix the aligners which did nothing.Now i have to pay out of pocket for dentist visits for the gap and braces to fix it and from all the pain she was in.The products do not adhere to fda guidelines and should be pulled off the market for children.

• Brand Name: SMILE DIRECT ALIGNERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): SMILEDIRECTCLUB S.A.
• MDR Report Key: 16732920
• MDR Text Key: 313330331
• Report Number: MW5116606
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Sex: Female
• Patient Weight: 45 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White