BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMILEDIRECTCLUB ALIGNER SYSTEM

    MDR report key: 12236233 · Received July 28, 2021

    Report

    Report Number
    3014658399-2021-00031
    Event Type
    Injury
    Date Received
    July 28, 2021
    Date of Event
    August 13, 2021
    Report Date
    August 25, 2021
    Manufacturer
    ACCESS DENTAL LAB
    Product Code
    NXC
    UDI-DI
    00850007728007
    PMA / PMN Number
    K191990
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS B3, B4, B5, G3 HAVE BEEN MODIFIED WITH ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER AND H6 (HEALTH EFFECT-CLINICAL CODE/IMPACT CODE/TYPER OF INVESTIGATION) HAS BEEN MODIFIED ACCORDING TO THE NEW INFORMATION PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT TOOTH #11 RESULTED IN EXTRACTION. THE CUSTOMER REQUIRED MEDICAL INTERVENTION FROM THE GENERAL DENTIST AND EXTRACTED THE TOOTH. THE CUSTOMER IS STILL WEARING THE ALIGNERS.

    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 TOOTH BREAKAGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING ALIGNER TREATMENT TEETH MOBILITY DEVELOPED AND A TOOTH CRACKED. THE CUSTOMER IS CURRENTLY SCHEDULED TO RECEIVE MEDICAL INTERVENTION. THE CUSTOMER COMPLETED THE ALIGNER TREATMENT PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139506 SMILEDIRECTCLUB ALIGNER SYSTEM SEQUENTIAL ALIGNER NXC ACCESS DENTAL LAB N/A N/A 00850007728007

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other