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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC. SMILEDIRECTCLUB ALIGNERS; ALIGNER, SEQUENTIAL

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SMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC. SMILEDIRECTCLUB ALIGNERS; ALIGNER, SEQUENTIAL Back to Search Results
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Sensitivity of Teeth (2427)
Date of Event 10/15/2019
Event or Problem Description
Pt has been in smile direct club aligners for the past 12 months, he presented with complaints that his bite was not right and he was hitting on his front teeth very hard.Upon exam, his maxilla is overexpanded, and he has traumatic occlusion on his anterior teeth.He displays mobility on upper incisors.Fda safety report id# (b)(4).
 
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Brand Name
SMILEDIRECTCLUB ALIGNERS
Common Device Name
ALIGNER, SEQUENTIAL
Manufacturer (Section D)
SMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC.
MDR Report Key9208029
Report NumberMW5090468
Device Sequence Number10667691
Product Code NXC
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 10/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date10/17/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age32 YR
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