MAUDE Adverse Event Report: ALIGN TECHNOLOGY ORTHODONTIC ALIGNERS; ALIGNER, SEQUENTIAL

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Pain (1994); Sensitivity of Teeth (2427)

Event Date 07/01/2019

Event Type  Injury  

Event Description

I started using smile direct's aligners in (b)(6) 2017.I was so excited to get started as i had always had crocked teeth but never could afford braces.Luckily, smile direct club, sdc, opened an office in my town, (b)(6), so i did not have to do impressions via mail.I had not been to the dentist in a while and had significant work previously done including crowns and caps.During my initial scan i mentioned that and you could easily see this on the scan.The tech didn't seem to think there would be any concerns.My treatment plan was relatively aggressive, i wore 2 aligners for 1 week each and then the next aligner in the series for 2 weeks.I complete my treatment in 6 months.Four months after my treatment was completed i began having pain in my jaw.One afternoon a tooth fell out forcing me to go to the dentist.While there i was surprised to learn that most of the work i had previously done had loosened and needed to be redone.This was now with (b)(6) worth of add'l work that i now needed.In the end, it was the recommendation of my dentist to get implants at (b)(6).When i reached out to sdc for a refund i was informed i was outside of their refund period, but they would review my case if i provided them with my dental records prior to treatment.They did not require dental records to start my treatment nor did they ask detailed questions about my prior dental health.Additionally, why would i spend (b)(6) on aligners to turn around and pay (b)(6) for implants? i believe i was either not a good candidate for their club or their negligence resulted in me losing my teeth.Sdc needs to be regulated and should require a dentist to oversee a pt while undergoing treatment.Fda safety report id# (b)(4).

• Brand Name: ORTHODONTIC ALIGNERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY
• MDR Report Key: 9706386
• MDR Text Key: 179447945
• Report Number: MW5092970
• 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: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 86