BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE CLAMP, TITANIUM

    MDR report key: 4171078 · Received October 14, 2014

    Report

    Report Number
    1723170-2014-01091
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 19, 2014
    Report Date
    November 9, 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. DEVICE LOT NUMBER, OR SERIAL NUMBER, NOT AVAILABLE AS PART WAS DISCARDED BY THE SITE. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. REPLACEMENT DEVICE SHIPPED TO SITE FOR ISSUE RESOLUTION. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR ANALYSIS AS SUSPECT DEVICE WAS DISCARDED BY THE SITE.

    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 THE SITE HAD A SPINE CLAMP WITH A STRIPPED SCREW. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650851 OPEN SPINE CLAMP, TITANIUM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1