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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Patient treatment from smile direct club without supervision of a dental professional.Movement of tooth #9 was done too quickly and resulted in killing the tooth.This would not have happened if the treatment use of a class ii medical device was overseen by a dental professional.The issue with smile direct club is evident from this case and many others.Fda safety report id # (b)(4).

• Brand Name: SMILE DIRECT CLUB
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): SMILE DIRECT CLUB/ ALIGN TECHNOLOGY, INC.
• MDR Report Key: 9511186
• MDR Text Key: 172594376
• Report Number: MW5091838
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 68