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

Device Problems Product Quality Problem (1506); Fitting Problem (2183)

Patient Problem Sensitivity of Teeth (2427)

Event Date 07/17/2019

Event Type  Injury  

Event Description

I used smile direct club aligners back in 2016 to correct my teeth.I was told in (b)(6) 2019 by my general dentist that i had receding gums and movement in my bottom two front teeth that was consistent with bone loss.I followed up with the (b)(6) to see what could be done to prevent further damage.They confirmed with x-rays and bone density scan that the bone protecting my front bottom teeth was completely gone as well as the bone between the teeth allowing them to wiggle.Without correcting this over the years i was told i could lose these two teeth.They are incredibly painful and sensitive due to the exposed roots.I can actually see the white roots completely exposed when i pull down my front bottom lip and is so severe the gums are completely gone.I also followed up periodontics and was told that i have severe gum recession on almost all my front teeth that require allografts which will be painful and expensive but are necessary to help stabilize the teeth and protect the roots.This permanent damage was due to smile direct club not taking in account the bone around the teeth and pushing the teeth too toward with too much force and then gave me an improper fitting retainer which perpetuated the damage.This bone loss i am told is permanent and the gum allografts will help with stabilization, but i will likely have continued sensitivity issues.I now have to go through another round orthodontic treatment with invisalign to recline and put my teeth back into the bone and fix traumatic occlusion caused by improper movement of my teeth then proceed with multiple surgeries for placement of the gum grafts.Smile direct has cost me so much pain and money and they need to be shut down.I've sat in many a dentist chairs in tears after being told about all the damage they caused my mouth.I never want this to happen to another unsuspecting person looking to straighten their teeth for cheap.I actually found that invisalign in the first place would have been a cheaper option and their claims that they are cheaper option is false when you take in account the money it will take to fix the problems they caused me.I had no f/u with an orthodontist during my smile direct club treatment, never talked to an orthodontist and took my own impressions.Now having invisalign and seeing what the f/u should be like, i am shocked that i never had a conversation with an orthodontist to discuss my treatment which i feel ultimately led to my permanent damage along with the faulted ai designed treatment.I did not f/u with the company because after some research there are many stories like mine.I had terrible experience with customer service during my treatment and found it impossible to get help with issues and was put on hold for 30 mins at a time when issues arose and felt that trying to report it to them would be a long feat.I went straight to fda to report that this product is causing people real bodily damage and harm.I will try to contact them to send me my treatment plan and diagnostic pictures to be used as reference for the damage to my gums before and after treatment.Fda safety report id# (b)(4).

• Brand Name: SMILE DIRECT CLUB INVISIBLE ALIGNERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): SMILE DIRECT CLUB / ALIGN TECHNOLOGY INC.
• MDR Report Key: 9720680
• MDR Text Key: 180123686
• Report Number: MW5093023
• 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: 02/12/2020

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: 02/14/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR