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

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

Patient Problem No Code Available (3191)

Event Date 04/16/2019

Event Type  malfunction  

Event Description

Pt is in the middle of smiledirects at home treatment.Tooth #26 has been pushed completely lingual and will eventually need further treatment.Pt said that smiledirects plan was just to push this tooth back and leave it like it is.Do you have a picture of the product? yes.Start: (b)(6) 2018.Is therapy still ongoing? yes.

• Brand Name: SMILEDIRECT
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.
• MDR Report Key: 8620024
• MDR Text Key: 145617224
• Report Number: MW5086710
• 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: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• 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: 90 YR