BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Z-LOOK3

    MDR report key: 5242132 · Received November 23, 2015

    Report

    Report Number
    3006948427-2015-00859
    Event Type
    Injury
    Date Received
    November 23, 2015
    Date of Event
    March 16, 2015
    Report Date
    November 19, 2015
    Manufacturer
    Z-SYSTEMS AG
    Product Code
    DZE
    PMA / PMN Number
    K062542
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    BIOMECHANICAL OVERLOAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773581 Z-LOOK3 ENDOSSEOUS DENTAL IMPLANT ROOT FORM DZE Z-SYSTEMS AG Z5C-50-10 17162

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other