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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Sleep Dysfunction (2517); No Code Available (3191)

Event Date 10/24/2019

Event Type  Injury  

Event Description

On (b)(6) 2019 pt came to our office due to pain and pressure in jaw.Pt has been using smiledirectclub clear aligners for ortho treatment.Pt was only getting 2 hours of sleep per night when wearing the aligner due to pain in jaw.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. ; TN 37219
• MDR Report Key: 9362586
• MDR Text Key: 167644002
• Report Number: MW5091228
• 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: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• 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
• 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: 18 YR