MAUDE Adverse Event Report: SMILEDIRECTCLUB / ALIGN TECHNOLOGY, INC. CLEAR TEETH ALIGNERS; ALIGNER, SEQUENTIAL

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

Patient Problem No Code Available (3191)

Event Date 10/14/2019

Event Type  Injury  

Event Description

I bought aligners from smiledirectclub to straighten my teeth.On my second set, the aligners were too tight when i put them in and i immediately had to take them out, when i did, a tooth came out with it.Fda safety report id# (b)(4).

• Brand Name: CLEAR TEETH ALIGNERS
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): SMILEDIRECTCLUB / ALIGN TECHNOLOGY, INC.
• MDR Report Key: 9213936
• MDR Text Key: 163168034
• Report Number: MW5090496
• 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: Patient
• Type of Report: Initial
• Report Date: 10/17/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR