BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S7 NAVIGATION SYSTEM

    MDR report key: 8622146 · Received May 17, 2019

    Report

    Report Number
    1723170-2019-02420
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Report Date
    May 17, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 961579, SERIAL/LOT #: (B)(4). ANALYSIS SUMMARY: AS RETURNED, THE ARRAY HAD BEEN ATTACHED TO A CLAMP. THE ARRAY HAD BEEN OVER-TIGHTENED. THE ATTACHMENT SCREW HEX HEAD IS INTACT AND FUNCTIONAL, BUT THE HEAD OF THE SCREW HAS TOOL MARKS. THE SCREWS WERE ABLE TO BE BROKE LOOSE. THE ARRAY IS OTHERWISE FULLY FUNCTIONAL. WITH MARKERS ATTACHED AND FULLY SEATED, THE ARRAY RETURNS GOOD GEOMETRY ERROR. 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 BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE MEDIUM TRACKER WAS STUCK ON THE CLAMP. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415047 S7 NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733856 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1