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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/27/2019

Event Type  Injury  

Event Description

Pt had initiated at-home dental aligners for correcting crowding and tooth rotations with smile direct club.Pt has 7 teeth with cavities and a retained primary tooth which is hyper-mobile with minimal root structure.Both issues should have been addressed prior to pt being approved for aligners.The primary tooth would likely have been extracted iatrogenically by the aligners.Fda safety report id # (b)(4).

• Brand Name: SMILE DIRECT CLUB ALIGNERS
• Type of Device: ALIGNERS, SEQUENTIAL
• Manufacturer (Section D): SMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC.
• MDR Report Key: 9581275
• MDR Text Key: 174882100
• Report Number: MW5092187
• 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: Dentist
• Type of Report: Initial
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 68