MAUDE Adverse Event Report: SMILEDIRECTCLUB S.A. ALIGNERS; ALIGNER, SEQUENTIAL

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Insufficient Information (4580)

Event Date 10/14/2020

Event Type  Injury  

Event Description

I was a patient of (b)(6).They measured and analyzed my teeth to make aligners specifically for me.They sent me dental aligners which did not conform to my teeth.When i further investigated, it looked like they sent me the aligners of a different patient, but labeled them with my name.Fda safety report id # (b)(4).

• Brand Name: ALIGNERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): SMILEDIRECTCLUB S.A.
• MDR Report Key: 10919338
• MDR Text Key: 218985135
• Report Number: MW5098142
• Device Sequence Number: 1
• Product Code: NXC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 75