BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMILEDIRECTCLUB ALIGNER SYSTEM

    MDR report key: 12186028 · Received July 16, 2021

    Report

    Report Number
    3014658399-2021-00008
    Event Type
    Injury
    Date Received
    July 16, 2021
    Date of Event
    June 1, 2021
    Report Date
    July 16, 2021
    Manufacturer
    ACCESS DENTAL LAB
    Product Code
    NXC
    UDI-DI
    00850007728007
    PMA / PMN Number
    K191990
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED BY THE PATIENT AND INTERNAL INVESTIGATION CONDUCTED BY ACCESS DENTAL LAB, THERE IS NO CONCLUSIVE EVIDENCE THAT SUPPORTS OR OPPOSES THE FACT THAT THE ALIGNERS CAUSED, CONTRIBUTED OR WOULD LIKELY CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THIS EVENT IS BEING FILED AS AN MDR SINCE THE PATIENT REPORTED SYMPTOMS OR PHYSIOLOGICAL CONDITIONS RELATED TO LOSS OF A TOOTH. REPORTED OUTSIDE OF THE 30 DAY REPORTING WINDOW DUE TO UPDATED REPORTING REQUIREMENTS ((B)(4)).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE DEVELOPED PAIN, SWELLING OF THE FACE, TOOTH INFECTION AND TOOTH EXTRACTION. THE CUSTOMER REQUIRED MEDICAL INTERVENTION AND SUBSEQUENTLY DISCONTINUED THE USE OF ALIGNERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081899 SMILEDIRECTCLUB ALIGNER SYSTEM SEQUENTIAL ALIGNER NXC ACCESS DENTAL LAB N/A N/A 00850007728007

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other