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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Irritation (1941); Pain (1994); Sensitivity of Teeth (2427)

Event Date 02/27/2018

Event Type  Injury  

Event Description

My son used aligners from smiledirectclub.His orthodontist feels that this caused some malalignment to his teeth and also caused impaction of one of his canine teeth, thus causing him to need traditional braces and resulting in oral surgery to save his permanent teeth.No x-rays were required prior to the dispensing of the aligners, he was only required to send in imprints of his teeth.Unbeknownst to us, he still had not lost at least six baby teeth, which kept falling out during the "treatment plan".My son had pain with the aligners, and also gum irritation.At the end of the therapy, he was to use retainers that was supposed to keep his teeth from shifting back into an inappropriate pattern.When i contacted one of their "smile experts" online, i was advised to use one pair of his previous aligners (which i didn't have, because they were worn, outgrown, and cracked"), which they always advise to keep.I tried to explain to this person that would be hard to do because of the wear and tear already on the aligner, but she insisted, even offering to send a new set of the last aligner, thus forcing my son to wear the previous month's set.At any rate, he could not wear them and that was that.He began to experience pain, and i took him to a dentist.During the x-rays, he was found to have the canine tooth impaction, and several baby teeth that had not erupted yet, thus necessitating an emergent referral to an orthodontist.My son required braces, and then oral surgery to expose a tooth, then bond the tooth to the braces.According to the orthodontist, there seems to be some extensive issues that we are unsure if their current treatment plan will be therapeutic and the health of the two front teeth is questionable.Required oral surgery.Fda safety report id# (b)(4).

• Brand Name: ALIGNERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): SMILE DIRECT CLUB /ALIGN TECHNOLOGY, INC.
• MDR Report Key: 9384077
• MDR Text Key: 168460469
• Report Number: MW5091335
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 13 YR