BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER 9735023 SOLERA 5.5/6.0 MAS

    MDR report key: 3852300 · Received June 5, 2014

    Report

    Report Number
    1723170-2014-00557
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    March 14, 2014
    Report Date
    November 9, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    OLO
    PMA / PMN Number
    K124004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER AND WEIGHT NOT AVAILABLE FROM THE SITE. DEVICE LOT NUMBER, OR SERIAL NUMBER, NOT AVAILABLE AT TIME OF THIS REPORT. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE AT THIS TIME. RMA ISSUED. REPLACEMENT SOLERA DRIVER SHIPPED (B)(4) 2014. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR ANALYSIS. PART NOT RETURNED TO MANUFACTURER.

    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.

    Additional Manufacturer Narrative · 1

    LOT # AND MFG DATE NOW PROVIDED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, DURING A SPINAL FUSION PROCEDURE, THE NAVIGATED SOLERA DRIVER TIP BECAME BENT. THE SURGEON COMPLETED PLACEMENT OF THE LAST SCREW USING THE DRIVER. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329288 DRIVER 9735023 SOLERA 5.5/6.0 MAS ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. 130512

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR