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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 01/10/2020

Event Type  Injury  

Event Description

Patients is military member who utilized smile direct club for orthodontic treatment.Upon completion of treatment, patient was seen for dental examination with moderate severe gingival disease and bone loss on teeth with mobility.Fda safety report id # (b)(4).

• Brand Name: SMILE DIRECT CLUB ORTHODONTIC TREATMENT
• Type of Device: ALIGNER SEQUENTIAL
• Manufacturer (Section D): SMILE DIRECT CLUB/ALIGN TECHNOLOGY, INC.
• MDR Report Key: 9596059
• MDR Text Key: 175827854
• Report Number: MW5092280
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 01/13/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/15/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR