MAUDE Adverse Event Report: SMILE DIRECT CLUB INVISIBLE ALIGNERS; ALIGNER SEQUENTIAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Date 03/11/2019

Event Type  Injury  

Event Description

I was a pt of (b)(6) from approx (b)(6) 2018 - (b)(6) 2018.I was never informed that their product may cause damage to my teeth.On (b)(6) 2019, i had a routine exam with my dentist, where i learned that several of my teeth were loose and my bite was off.My dentist was concerned and referred me to an orthodontist, who confirmed the same.I now need orthodontic treatment to correct my bite alignment so that no further damage is done.

• Brand Name: INVISIBLE ALIGNERS
• Type of Device: ALIGNER SEQUENTIAL
• Manufacturer (Section D): SMILE DIRECT CLUB
• MDR Report Key: 8448214
• MDR Text Key: 139800930
• Report Number: MW5085111
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 64