BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLY LEGACY 2 IMPLANT

    MDR report key: 11783082 · Received May 6, 2021

    Report

    Report Number
    3001617766-2021-02434
    Event Type
    Injury
    Date Received
    May 6, 2021
    Date of Event
    April 17, 2021
    Report Date
    May 6, 2021
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC
    Product Code
    DZE
    UDI-DI
    10841307107361
    PMA / PMN Number
    K192221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683941 SIMPLY LEGACY 2 IMPLANT DENTAL IMPLANT DZE IMPLANT DIRECT SYBRON MANUFACTURING LLC NA 121434 10841307107361

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention