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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Sensitivity of Teeth (2427); Blood Loss (2597)

Event Date 08/29/2019

Event Type  Injury  

Event Description

Pt used mail order aligners ordered from (b)(6) to correct spacing between teeth.Treatment resulted only in consolidating the spaces into the areas between canines and lateral incisors.Retraction of upper incisors resulted in premature contacts of the upper and lower incisors.This has left the pt unable to chew properly due to a posterior open bite (back teeth don't touch) and the upper incisors are mobile due to the heavy occlusal contacts (they take all the force of the bite).In addition, the pt reports her gums bleed every morning when she removes the aligners.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. ; nashville TN 37219
• MDR Report Key: 8960253
• MDR Text Key: 156591315
• Report Number: MW5089520
• 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: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 18 YR