BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLY INTERACTIVE IMPLANT

    MDR report key: 11649619 · Received April 12, 2021

    Report

    Report Number
    3001617766-2021-02171
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Report Date
    April 12, 2021
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC
    Product Code
    DZE
    UDI-DI
    10841307106937
    PMA / PMN Number
    K130572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE REQUESTED INFORMATION BECOMES AVAILABLE, A SUPPLEMENTARY REPORT WILL BE SUBMITTED. THIS COMPLAINT IS BEING SUBMITTED LATE DUE TO THE FURLOUGHS THAT RESULTED FROM THE GLOBAL PANDEMIC AND IS CAPTURED WITHIN DEVIATION (B)(4).

    Description of Event or Problem · 1

    PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PRODUCT FIT WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546485 SIMPLY INTERACTIVE IMPLANT DENTAL IMPLANT DZE IMPLANT DIRECT SYBRON MANUFACTURING LLC NA 144579 10841307106937

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR