MAUDE Adverse Event Report: SMILE DIRECT CLUB / ALIGN TECHNOLOGY INC. SMILE DIRECT CLUB ALINGER TRAYS; ALIGNER SEQUENTIAL

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Pain (1994); Sensitivity of Teeth (2427); Difficulty Chewing (2670)

Event Date 07/12/2019

Event Type  Injury  

Event Description

Smile direct club engaged in deceptive practices promising my minor child straight teeth with their aligners, however the aligner trays caused my child bite to be off causing pain, malocclusion, difficulty chewing and eating, making her teeth worse than prior to the liners.They also dealt only with my minor child, entering her into a contract and receiving payment from her with a debt card not in her name.We now have to have her in braces to correct damage done.Fda safety report id# (b)(4).

• Brand Name: SMILE DIRECT CLUB ALINGER TRAYS
• Type of Device: ALIGNER SEQUENTIAL
• Manufacturer (Section D): SMILE DIRECT CLUB / ALIGN TECHNOLOGY INC.
• MDR Report Key: 9213742
• MDR Text Key: 163146589
• Report Number: MW5090485
• 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: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Weight: 44