BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM TAP (CANNULATED)

    MDR report key: 3187823 · Received June 25, 2013

    Report

    Report Number
    1723170-2013-00470
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT PROVIDED FROM THE SITE. DEVICE LOT NUMBER, OR SERIAL NUMBER, NOT AVAILABLE AT TIME OF THIS REPORT. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE AT THIS TIME. RMA ISSUED. REPLACEMENT TAP 4.5 SHIPPED TO SITE (B)(4) 2013. SUSPECT DEVICE HAS NOT BEEN RETURNED TO MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED A 4.5MM TAP FOUND CLOGGED DURING A SPINE PROCEDURE. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289126 4.5MM TAP (CANNULATED) NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1