BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 NAVIGATION

    MDR report key: 10704953 · Received October 20, 2020

    Report

    Report Number
    1723170-2020-02746
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    September 28, 2020
    Report Date
    November 16, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9733235, LOT/SERIAL:UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    LOT NUMBER: 200115. THE PERC PIN WAS RETURNED TO THE MANUFACTURER. VISUAL/PHYSICAL EXAMINATION CONFIRMED THE PERC PIN WAS BENT AND BROKEN. THIS ISSUE WAS CAUSED BY PHYSICAL DAMAGE. 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 DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT WHEN INSERTING THE PERC PIN, IT BROKE. THERE WAS NO IMPACT ON PATIENT OUTCOME AND THE PROCEDURE WAS DELAYED BY LESS THAN AN HOUR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THE PERC PIN SNAPPED BUT WAS STILL ATTACHED AND EVERYTHING WAS SUCCESSFULLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170093 STEALTHSTATION S7 NAVIGATION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733856 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR