BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.75MM TAP (NON-CANNULATED)

    MDR report key: 3911070 · Received July 2, 2014

    Report

    Report Number
    1723170-2014-00715
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 9, 2014
    Report Date
    November 10, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    OLO
    PMA / PMN Number
    K124004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SEX WAS UNAVAILABLE FROM THE SITE. DEVICE MANUFACTURE DATE WAS UNAVAILABLE AS NO LOT NUMBER WAS PROVIDED. NO PARTS HAVE BEEN RECEIVED BY THE 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 A GLOBUS REPRESENTATIVE REPORTED THAT THE 3.75 NAVIGATED TAP WAS BENT WHILE THE SURGEON DROVE IT INTO THE SPINE PEDICLE. THE SURGEON FINISHED THE SURGERY WITH THE USE OF NAVIGATION. THERE WAS NO REPORTED IMPACT TO THE OUTCOME OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386060 3.75MM TAP (NON-CANNULATED) ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. 130712

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR