BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMILEDIRECTCLUB ALIGNER SYSTEM

    MDR report key: 12322546 · Received August 15, 2021

    Report

    Report Number
    3014658399-2021-00043
    Event Type
    Injury
    Date Received
    August 15, 2021
    Date of Event
    July 16, 2021
    Report Date
    September 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
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H6 "MEDICAL DEVICE PROBLEM CODE" HAS BEEN MODIFIED WITH THE CORRECT INFORMATION.

    Additional Manufacturer Narrative · 0

    SECTIONS B.4 AND B.5 HAVE 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 DESCRIBE SYMPTOMS OF GUMS INFECTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DEVELOPING IRRITATION ON THE GUMS, SWELLING AND INFECTION OF GUMS BECAUSE OF THE USE OF INVISIBLE ALIGNERS. THE CUSTOMER STATED THAT MEDICATIONS WERE PRESCRIBED TO ALLEVIATE THE SYMPTOMS, WHICH DID NOT HELP; THEREFORE, MEDICAL INTERVENTION WAS REQUIRED TO PREVENT THE GUMS FROM FURTHER DAMAGE. AS A RESULT, ALIGNER TREATMENT WAS DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219605 SMILEDIRECTCLUB ALIGNER SYSTEM SEQUENTIAL ALIGNER NXC ACCESS DENTAL LAB N/A N/A 00850007728007

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other