BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE CLAMP, TITANIUM

    MDR report key: 3033826 · Received April 3, 2013

    Report

    Report Number
    1723170-2013-00247
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 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

    THE SUSPECT DEVICE LOT NUMBER AND MANUFACTURE DATE IS PROVIDED.

    Additional Manufacturer Narrative · 1

    NO PATIENT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION. THE SUSPECT DEVICE LOT NUMBER AND MANUFACTURE DATE ARE UNAVAILABLE AT THIS TIME. NO PARTS OR FILES HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. THE SITE HAS CHOSEN NOT TO RETURN THE SUSPECT CLAMP. THEY HAVE REMOVED IT FROM SERVICE AND ARE USING ANOTHER CLAMP THEY ALREADY HAD.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SITE'S OPEN SPINE CLAMP WILL NO LONGER TIGHTEN. THE SCREW IS ALLEGEDLY STRIPPED. THIS ISSUE WAS NOTICED DURING CLEANING, NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136794 OPEN SPINE CLAMP, TITANIUM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 120301

    Patients

    Seq Age Sex Outcome Treatment
    1