BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Z-LOOK3

    MDR report key: 2941309 · Received February 4, 2013

    Report

    Report Number
    3006948427-2012-00477
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    September 12, 2012
    Report Date
    January 18, 2013
    Manufacturer
    Z-SYSTEMS AG
    Product Code
    DZE
    PMA / PMN Number
    K062542
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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
    47166 Z-LOOK3 ENDOSSEOUS DENTAL IMPLANT ROOT FORM DZE Z-SYSTEMS AG Z3 EVO-40-13 14067

    Patients

    Seq Age Sex Outcome Treatment
    1 Other