BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMILEDIRECTCLUB ALIGNER SYSTEM

    MDR report key: 13115193 · Received December 29, 2021

    Report

    Report Number
    3014658399-2021-00125
    Event Type
    Injury
    Date Received
    December 29, 2021
    Date of Event
    October 18, 2021
    Report Date
    November 17, 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

    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 TOOTH FRACTURE, FOLLOWED BY TOOTH INFECTION, WHICH RESULTED IN NECROSIS OF THE TOOTH.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A TOOTH BROKE WHILE WEARING THE ALIGNERS, FOLLOWED BY INFECTION OF THE TOOTH THAT RESULTED IN TOOTH NECROSIS. THE CUSTOMER REQUIRED MEDICAL INTERVENTION; A ROOT CANAL AND RESTORATIVE WORK WAS PERFORMED. AS A RESULT, ALIGNER TREATMENT WAS DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2012999 SMILEDIRECTCLUB ALIGNER SYSTEM SEQUENTIAL ALIGNER NXC ACCESS DENTAL LAB N/A N/A 00850007728007

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Unknown Required Intervention| O