SMILE DIRECT CLUB

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-06 for SMILE DIRECT CLUB manufactured by Smile Direct Club / Align Technology, Inc..

Event Text Entries

[174177319] Pt completed orthodontic treatment using smile direct club without supervision of licensed dentist. Pt is diagnosed with generalized chronic moderate to severe periodontal disease. Pt is not a good candidate for orthodontic treatment due to gross caries and moderate to severe periodontal disease but completed orthodontic treatment with the company known as smile direct club. Pt should have been referred to dentist to complete needed treatment before orthodontic was started and completed. Pt is now concerned about loose teeth on the lower anterior teeth #23-26. Radiographs indicated severe bone loss around teeth #22-26 with generalized severe calculus present. Completing orthodontic treatment under these oral conditions has adverse effects on teeth and supporting periodontal tissues. Pt will now have to have teeth #23-26 extracted sometime in the near future. Pts should have a full exam completed including radiographs and be monitored by a licensed dentist during any orthodontic treatment. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5092064
• MDR Report Key: 9559130
• Date Received: 2020-01-06
• Date of Event: 2019-10-01
• Date Added to Maude: 2020-01-07
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SMILE DIRECT CLUB
• Generic Name: ALIGNER, SEQUENTIAL
• Product Code: NXC
• Date Received: 2020-01-06
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-01-06