MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC. SMILEDIRECTCLUB; ALIGNER, SEQUENTIAL

Device Problem Output Problem (3005)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 08/06/2019

Event Type  Injury  

Event Description

After wearing all the custom clear aligners from smiledirectclub over a 6 month period, bride's teeth were not straightened and in fact they were more misaligned than before.Bride reported that she got no resolution with customer service and was very frustrated.Fda safety report id# (b)(4).

• Brand Name: SMILEDIRECTCLUB
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.
• MDR Report Key: 9214055
• MDR Text Key: 163301162
• Report Number: MW5090501
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/17/2019

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• 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: 64