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

Device Problems Stretched (1601); Material Too Soft/Flexible (4007)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/26/2020

Event Type  Injury  

Event Description

I used the smile direct club invisible aligners.These are made very cheaply and get soft in your mouth quickly stretching.They are tight initially and move your teeth slightly but then get soft so your teeth move back, each consecutive pair did this for me so the next pair made my teeth move even more significantly not gradually because they had returned to their initial position.This caused bad pain and multiple teeth to become loose and wiggle.Also bleeding occurred in my top right incisor.I was given 3 re-evaluations/new sets of aligners, the product never fixed the initial issue with my teeth (a small gap in the front) and changed my bite so my molars cannot touch/chew.Fda safety report id# (b)(4).

• Brand Name: CLEAR ALIGNERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): SMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC.
• MDR Report Key: 11064712
• MDR Text Key: 223600667
• Report Number: MW5098489
• Device Sequence Number: 3
• Product Code: NXC
• 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: 12/18/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 70