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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMILEDIRECTCLUB / ALIGN TECHNOLOGY, INC. SMILE DIRECT CLUB CLEAR ALIGNER; ALIGNER, SEQUENTIAL
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SMILEDIRECTCLUB / ALIGN TECHNOLOGY, INC. SMILE DIRECT CLUB CLEAR ALIGNER; ALIGNER, SEQUENTIAL Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Code Available (3191)
Event Date 01/01/2018
Event Type  Injury  
Event Description
Pt was "approved" for clear aligners through smile direct club, although she was not a candidate for this product.This product is not designed for severe malocclusion, she was led to believe that she was a candidate.Pt came to my practice so that i can "fix" the damage that has occurred, and hopefully, she will not have permanent damage with her occlusion / bite.Pts pre-orthodontic diagnosis was class iii openbite with maxillary and mandibular crowding.She finished her clear aligners with straight teeth, but with a much more severe openbite and unesthetic extruded mandibular canines.Pt was unable to bite properly.Smile direct club: (b)(6) 2018 - (b)(6) 2018.Fda safety report id# (b)(4).
 
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Brand Name
SMILE DIRECT CLUB CLEAR ALIGNER
Type of Device
ALIGNER, SEQUENTIAL
Manufacturer (Section D)
SMILEDIRECTCLUB / ALIGN TECHNOLOGY, INC.
MDR Report Key9458389
MDR Text Key170693494
Report NumberMW5091600
Device Sequence Number1
Product Code NXC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Dentist
Type of Report Initial
Report Date 12/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age36 YR
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