BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE CLAMP, TITANIUM

    MDR report key: 3163531 · Received June 11, 2013

    Report

    Report Number
    1723170-2013-00431
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT A SITE OR COORDINATOR IDENTIFIED A STRIPPED OPEN SPINE CLAMP SCREW. THE SURGEON NOTICED THE SCREW AND COMPLETED THE PROCEDURE USING THE NAVIGATION SYSTEM AND A THORACIC OPEN SPINE CLAMP. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263908 OPEN SPINE CLAMP, TITANIUM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1