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

Device Problem Failure to Align (2522)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

I used smile direct club aligners for orthodontic treatment.The end result is that i need expensive corrective treatment to fix the misalignment of all my back teeth.They are twisted and tilted and i can no longer chew properly.I spent thousands of dollars on smile direct because i was self conscious of my smile and the company offered a solution that was cheaper than other options.My dentist is fearful that i will have serious issues for the rest of my life because my jaw and teeth are no longer aligned properly.Fda safety report id# (b)(4).

• Brand Name: SMILE DIRECT ALIGNERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.
• MDR Report Key: 9659200
• MDR Text Key: 177586471
• Report Number: MW5092681
• 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: Patient
• Type of Report: Initial
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR