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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Code Available (3191)

Event Date 04/30/2019

Event Type  malfunction  

Event Description

Pt presented to our office with an anterior and posterior open bite - the pt was only biting on her r and l second molars.No other teeth were in occlusion.She had complained to smile direct club about only being able to bite on two teeth on each side.They reported to her that they could not fix her problem and simply told her to "enjoy her smile." i believe the issue could have been corrected with professional level services.We were only able to partially correct her issue with a bite adjustment.

• Brand Name: SMILE DIRECT CLUB DENTAL ALIGNERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.
• MDR Report Key: 8605119
• MDR Text Key: 145088942
• Report Number: MW5086585
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): Y
• 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: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• 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: 20 YR