BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMILEDIRECTCLUB ALIGNER SYSTEM

    MDR report key: 12411582 · Received September 1, 2021

    Report

    Report Number
    3014658399-2021-00058
    Event Type
    Injury
    Date Received
    September 1, 2021
    Date of Event
    August 3, 2021
    Report Date
    September 27, 2021
    Manufacturer
    ACCESS DENTAL LAB
    Product Code
    NXC
    UDI-DI
    00850007728007
    PMA / PMN Number
    K191990
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4 "SERIAL NUMBER AND UNIQUE IDENTIFIER (UDI)" HAS BEEN MODIFIED WITH THE CORRECT INFORMATION.

    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 THAT LED INFECTION AND RESULTED IN NECROSIS OF THE TOOTH.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT TOOTH #18 WAS INFECTED AND RESULTED IN NECROSIS OF THE TOOTH. THE CUSTOMER REQUIRED EVALUATION FROM AN DENTIST BUT NO MEDICAL INTERVENTION HAS BEEN PERFORMED AS OF YET. AS A RESULT, ALIGNER TREATMENT WAS DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1304827 SMILEDIRECTCLUB ALIGNER SYSTEM SEQUENTIAL ALIGNER NXC ACCESS DENTAL LAB N/A N/A 00850007728007

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other