BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Z-LOOK3

    MDR report key: 2850006 · Received November 29, 2012

    Report

    Report Number
    3006948427-2012-00470
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    November 3, 2012
    Report Date
    November 29, 2012
    Manufacturer
    Z-SYSTEMS AG
    Product Code
    DZE
    PMA / PMN Number
    K062542
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DENTAL IMPLANT DID NOT OSSEOINTEGRATE AND HAD TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Z-LOOK3 ENDOSSEOUS DENTAL IMPLANT ROOT FORM DZE Z-SYSTEMS AG Z3 EVO-50-10 14068

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other