BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLERA DRIVER 4.75 STANDARD MAS

    MDR report key: 5095193 · Received September 22, 2015

    Report

    Report Number
    1723170-2015-01130
    Event Type
    Malfunction
    Date Received
    September 22, 2015
    Date of Event
    August 24, 2015
    Report Date
    January 25, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC. (MSB)
    Product Code
    OLO
    PMA / PMN Number
    K140454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING DATE IS UNAVAILABLE. RETURN REQUESTED. REPLACEMENT SOLERA DRIVER 4.75 STANDARD SHIPPED TO SITE 08/26/2015. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT SOLERA DRIVER 4.75 STANDARD FINDS THAT THE DRIVER HAS TWO LINES OF GALLING NEAR THE KNUCKLE THAT IS CAUSING MINOR FIT ISSUES WITH THE RETURNED NAVLOCK TRACKER. AS IS, THE TWO PARTS MATE EASILY WITH THE DRIVER ROTATING WITHOUT ISSUE. MECHANICAL FAILURE. GALLING.

    Additional Manufacturer Narrative · 1

    CORRECTION: PER FURTHER REGULATORY REVIEW, IT WAS DETERMINED THAT THE MANUFACTURER OF RECORD FOR THE REPORTED DEVICE RELATED TO THIS MDR WAS MEDTRONIC SOFAMOR DANEK USA, INC. (MSB). MSB WAS NOTIFIED OF THIS REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING DATE NOW PROVIDED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, THE SITE'S ORANGE NAVLOCK AND THEIR SOLERA 4.75 DRIVER LOCKED-UP, KEEPING THE DRIVER FROM ROTATING WITHIN THE NAVLOCK. THE MEDTRONIC REPRESENTATIVE USED A MALLET TO SEPARATE THE TWO INSTRUMENTS. AFTER SEPARATION, THE TWO PIECES FIT TOGETHER WELL ENOUGH TO FUNCTION FOR THE PROCEDURE., BUT STILL "CAUGHT SLIGHTLY" WHILE BEING USED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM AND THE TWO INSTRUMENTS. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626904 SOLERA DRIVER 4.75 STANDARD MAS NEUROLOGICAL STEREOTAXIC INSTRUMENT OLO MEDTRONIC SOFAMOR DANEK USA, INC. (MSB) CA14J051

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR