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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 03/11/2020

Event Type  Injury  

Event Description

Pt is using smile direct club.Pt is almost done with treatment (only three trays left).If the case was overseen by an orthodontist, the number of trays she has left would mean her teeth were about in the correct position and only a few minor changes to go.Pt however still has crowded, overlapping lower lateral incisors and canines.Pt has a 2mm midline discrepancy.Pt has numerous flared maxillary teeth, rotated teeth, and both arches have teeth that are not in the correct arch form.Fda safety report id# (b)(4).

• Brand Name: SMILE DIRECT CLUB
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): SMILE DIRECT CLUB / ALIGN TECHNOLOGY INC.
• MDR Report Key: 9834731
• MDR Text Key: 183738391
• Report Number: MW5093749
• 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: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR