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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Code Available (3191)

Event Date 06/01/2019

Event Type  malfunction  

Event Description

Smile direct club advertised that they could fix a small gap in my middle teeth.They made the gap worse, after another treatment plan, they said an orthodontist reviewed it and approved an add'l plan.After a month, it was worse.They then said they can't fix it and there is nothing they can do.They claim it's unfixable with aligners.They told me they could fix it and charged me (b)(6) and made it worse.Now my bite is bad when i could bite correctly before.Fda safety report id# (b)(4).

• Brand Name: SMILE DIRECT CLUB ALIGNERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): SMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC.
• MDR Report Key: 8981390
• MDR Text Key: 158644597
• Report Number: MW5089647
• 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: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 70