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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMILEDIRECTCLUB / ALIGN TECHNOLOGY INC. ALIGNERS; ALIGNER SEQUENTIAL
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SMILEDIRECTCLUB / ALIGN TECHNOLOGY INC. ALIGNERS; ALIGNER SEQUENTIAL Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Inadequate Pain Relief (2388)
Event Date 08/14/2019
Event Type  malfunction  
Event Description
Six month aligner treatment - noticed the requested treatment (gap closing) was not being met.I expressed my concerns and was approved and scheduled for a reevaluation.Received an email with an updated 3d scan of an add'l 2 month treatment plan yet this plan did not address concerns nor was information given to me on why until i requested an explanation.It is then that i was told the spacing created by the treatment could not be addressed due to aligner treatment not supporting it.I was then told to go to the dentist for veneers or bonding after trusting their professional "expertise" and paying for a treatment that caused issues that could not be addressed.The explanation was that the treatment that was provided was what was predicted.The scan "shows" the spacing yet i was also told that the 3d scan can show inaccurate progression due to multiple factors.Fda safety report id# (b)(4).
 
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Brand Name
ALIGNERS
Type of Device
ALIGNER SEQUENTIAL
Manufacturer (Section D)
SMILEDIRECTCLUB / ALIGN TECHNOLOGY INC.
MDR Report Key9335054
MDR Text Key166982807
Report NumberMW5091130
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 Patient
Type of Report Initial
Report Date 11/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age28 YR
Patient Weight138
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