BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3D-KIT SIEMENS ISO-C

    MDR report key: 2913910 · Received December 6, 2012

    Report

    Report Number
    3007582679-2012-00054
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    STRYKER NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K012380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A NAVIGATED PROCEDURE, 3D-KIT SIEMENS ISO-C CAUSED A 30 MINUTE DELAY BECAUSE THE C-ARM WOULD NOT ACTIVATE. AS A RESULT, NAVIGATION WAS ABORTED AND THE PROCEDURE WAS COMPLETED AND THE PROCEDURE WAS COMPLETED USING STANDARD 2D FLUORO WITHOUT INCIDENT. NO ADVERSE CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3D-KIT SIEMENS ISO-C HAW STRYKER NAVIGATION 11107

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK