BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE CLAMP DRIVER

    MDR report key: 3770715 · Received April 24, 2014

    Report

    Report Number
    1723170-2014-00409
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 26, 2014
    Report Date
    November 10, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K990214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT DEVICE FINDS THAT THE TIP OF THE DRIVER WAS WELL WORN AND ROUNDED OVER. DESPITE THE WEAR, THE DRIVER WAS STILL FUNCTIONAL BEING ABLE TO ADJUST A SPINE CLAMP WITHOUT ISSUE. THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE WAS THAT THE DRIVER WAS WORN OUT OVER TIME DUE TO EXCESSIVE FORCE APPLIED TO THE TIP OF THE INSTRUMENT.

    Additional Manufacturer Narrative · 1

    CORRECTION: ON 13-OCT-2015, IT WAS NOTICED THAT A PREVIOUS MDR SUBMISSION CONTAINED INCORRECT INFORMATION WITH REGARDS TO THE COMMON DEVICE NAME, PRODUCT CODE AND/OR PMA/510(K). THIS MDR IS BEING SUBMITTED TO CORRECT THIS INFORMATION. THERE IS NO NEW INFORMATION TO CHANGE THE PATIENT INFORMATION, EVENT DESCRIPTION OR MANUFACTURER NARRATIVE THAT WAS PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE CLAMP DRIVER INSTRUMENT WAS STRIPPED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248652 OPEN SPINE CLAMP DRIVER NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 120207

    Patients

    Seq Age Sex Outcome Treatment
    1