BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLY INTERACTIVE IMPLANT

    MDR report key: 11685215 · Received April 19, 2021

    Report

    Report Number
    3001617766-2021-02242
    Event Type
    Injury
    Date Received
    April 19, 2021
    Date of Event
    March 22, 2021
    Report Date
    April 19, 2021
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC
    Product Code
    DZE
    UDI-DI
    10841307106890
    PMA / PMN Number
    K130572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S WEIGHT IS UNKNOWN. DEVICE EVALUATION RESULTS ARE NOT AVAILABLE. WHEN THE ANALYSIS IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581897 SIMPLY INTERACTIVE IMPLANT DENTAL IMPLANT DZE IMPLANT DIRECT SYBRON MANUFACTURING LLC NA 131420 10841307106890

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention