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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC. SMILE DIRECT CLUB; ALIGNER, SEQUENTIAL
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SMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC. SMILE DIRECT CLUB; ALIGNER, SEQUENTIAL Back to Search Results
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Deformity/ Disfigurement (2360)
Event Type  Injury  
Event Description
I had an adult patient yesterday who recently completed a course of treatment and a refinement with smile direct club.He had no exam with a doctor or x- rays prior to his orthodontic treatment.He has periodontally compromised teeth that were moved with no regard for the longevity of the teeth.He now has a traumatic occlusion on these periodontally compromised teeth that if untreated will result in their early loss.Additionally, he has a posterior open bite, has difficulty chewing and shifts his jaw to try to find a comfortable biting position, which may lead to temporo-mandibular discomfort.This is not the first time i saw a patient unhappy with smile direct.This is a prime example of malpractice by smile direct.Smile direct, candid and other companies like this are threats to public health.They currently do not meet the standard of care for treating patients orthodontically and thus should not be allowed to practice dentistry.
 
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Brand Name
SMILE DIRECT CLUB
Type of Device
ALIGNER, SEQUENTIAL
Manufacturer (Section D)
SMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC.
MDR Report Key9295620
MDR Text Key166151471
Report NumberMW5090977
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 10/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2019
Is this an Adverse Event Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age50 YR
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