BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLERA DRIVER 4.75 STANDARD MAS

    MDR report key: 5822714 · Received July 26, 2016

    Report

    Report Number
    1723170-2016-01955
    Event Type
    Malfunction
    Date Received
    July 26, 2016
    Date of Event
    June 28, 2016
    Report Date
    July 27, 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 DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. ON (B)(6) 2016 RETURN REQUESTED FOR SUSPECT SOLERA 4.75 STANDARD DRIVER. NO PARTS HAVE BEEN RECEIVED BY MANUFACTURER FOR ANALYSIS. NO PARTS WERE REPLACED. NO FURTHER ISSUES HAVE BEEN REPORTED. PART NOT RECEIVED BY MANUFACTURER.

    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.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, AND DURING SCREW PLACEMENT, THE TIP OF THE SITE'S STANDARD DRIVER BROKE OFF INTO THE SCREW HEAD. SWITCHED TO A REDUCTION DRIVER TO CONTINUE THE PROCEDURE. NO FURTHER DETAILS REGARDING THIS ISSUE, OR SPECIFICALLY HOW THE DAMAGE OCCURRED, WERE PROVIDED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. DELAY IN THERAPY WAS LESS THAN 2 MINUTES. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475602 SOLERA DRIVER 4.75 STANDARD MAS ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC SOFAMOR DANEK USA, INC. (MSB) CA14J053

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR