BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IGS

    MDR report key: 8698651 · Received June 14, 2019

    Report

    Report Number
    1723170-2019-03321
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Report Date
    June 14, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K131425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE 961-578 FOUND A DAMAGED TOOL. THE HEX HEAD OF THE ADJUSTMENT SCREW HAD BEEN ROUNDED OUT RENDERING THE SCREW UNUSABLE. THERE WERE TOOL MARKS AROUND THE OUTSIDE EDGE OF THE HEAD OF THE SCREW AS WELL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM WHILE OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE MEDIUM SURETRACK CLAMP HAD A STRIPPED SCREW. THERE WAS NO PATIENT PRESENT WHEN THE ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495217 IGS INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 961578 150317

    Patients

    Seq Age Sex Outcome Treatment
    1