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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Sensitivity of Teeth (2427)

Event Date 11/25/2019

Event Type  Injury  

Event Description

Device: smile direct club orthodontic clear aligner; event: suspect that aligners have caused pt's dentition to deviate from normal occlusion (especially anterior).Pt reports complaining to the mfr regarding this issue prior to the date.Reports a feeling of "pressure" in the ul quadrant where pt has missing teeth #12, 13 exam shows no other issues (no caries, no bone loss etc.), however pt is due for a deep scaling and root planing.Problem: pt not educated by mfr regarding potential side effects of device.Pt advised that some pressure from the aligners is normal as this is signifying tooth movement, but too much pressure is a cause for cancer.Pt states that she was not given any info regarding this side effect, and is concerned about the movement being too much (pointing to anterior teeth as prior) product use: uncertain that pt is using product as directed as there is no direct provider responsible for pt fu.Uncertain that product is being manufactured as directed as there is no direct provider responsible for identifying if the product is made correctly for each aligner.Outcome: tooth movement that is not expected or wanted by the pt.Majorly the issue is that the anterior tooth movement does not appear to be desirable by the pt, and is also causing issues due to anterior guidance / excursive movement interference by the anterior dentition (8/9 and 23-26).For example: pt points to #9 being kicked out by a millimeter, and the 23-26 lower anteriors are insically positioned compared to where they should be (supra-erupted) by about 2-3 mm.This is a recent development from the use of said product per pt.Required intervention: strongly suggested that the pt seek professional orthodontic guidance as continued use of aligners without anyone there to monitor progression may not lead to a desirable esthetic result and may result in major issues with pt's occlusion long term as well.Fda safety report id# (b)(4).

• Brand Name: SMILE DIRECT CLUB CLEAR ALIGNERS ALIGN TECHNOLOGY, INC.
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): SMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC.; nashville TN 37219
• MDR Report Key: 9384059
• MDR Text Key: 168456479
• Report Number: MW5091334
• 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: Dentist
• 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
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 46 YR