BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMILEDIRECTCLUB ALIGNER SYSTEM

    MDR report key: 13078626 · Received December 23, 2021

    Report

    Report Number
    3014658399-2021-01667
    Event Type
    Injury
    Date Received
    December 23, 2021
    Date of Event
    April 23, 2021
    Report Date
    December 23, 2021
    Manufacturer
    ACCESS DENTAL LAB
    Product Code
    NXC
    PMA / PMN Number
    K191990
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 A TOOTH INFECTION. AS PER CAPA #(B)(4) THIS EVENT IS RETROSPECTIVELY BEING REPORTED AND THEREFORE WAS NOT REPORTED WITHIN THE REQUIRED 30-DAYS.

    Description of Event or Problem · 0

    ON (B)(6) 2021 THE CUSTOMER REPORTED AN INFECTION WHILE WEARING THE ALIGNERS, THE CUSTOMER WAS NOT ABLE TO PROVIDE THE IMPACTED TOOTH NUMBER. IT IS UNKNOWN IF MEDICAL INTERVENTION WAS REQUIRED. IT IS UNKNOWN IF ALIGNER TREATMENT WAS DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1974828 SMILEDIRECTCLUB ALIGNER SYSTEM SEQUENTIAL ALIGNER NXC ACCESS DENTAL LAB

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Unknown Other