BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE ANGLED CLAMP

    MDR report key: 3910354 · Received July 2, 2014

    Report

    Report Number
    1723170-2014-00710
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    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. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. NO PARTS HAVE BEEN RETURNED TO MANUFACTURER FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    MFG DATE NOW PROVIDED.EVALUATION OF THE SUSPECT CLAMP FINDS: THE CLAMP FACE IS BENT TO ONE SIDE. THE ADJUSTMENT SCREWS THREADS ARE WORN IN THE MIDDLE OF TRAVEL AND HAVE DEBRIS IN THE THREADS AS WELL. THE SCREW HEAD HAD TOOL MARKS AROUND THEM. THE ATTACHMENT SCREW IS STRETCHED FROM OVER TIGHTENING CAUSING SOME MOVEMENT IN THE CLAMP FACE. A REPLACEMENT CLAMP WAS SENT TO THE SITE FOR ISSUE RESOLUTION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A SITE IDENTIFIED AN OPEN SPINE CLAMP WITH STRIPPED SCREWS. THE DAMAGED SCREWS WERE DISCOVERED WHILE IN STERILE PROCESSING AT THE SITE. 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
    387752 OPEN SPINE ANGLED CLAMP NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 200310071268

    Patients

    Seq Age Sex Outcome Treatment
    1