BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICREA DRIVER

    MDR report key: 17526050 · Received August 12, 2023

    Report

    Report Number
    MW5132990
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    December 14, 2016
    Report Date
    March 9, 2017
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    HXX
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A SPINAL FUSION CASE, THE SURGEON EXPERIENCED AN INACCURACY WHILE NAVIGATING A NON-MEDTRONIC MEDICREA DRIVER WITH A MEDTRONIC NAVLOCK TRACKER. THE MEDICREA DRIVER WAS TRACKING 10MM DEEPER INTO THE ANATOMY THAN IT WAS PHYSICALLY. THE REP FOR MEDICREA WAS PRESENT AND SAID THE DRIVER SHOULD TRACK LIKE A MEDTRONIC DRIVER. THE SURGEON CHECKED THE MEDTRONIC PASSIVE PLANAR AND THORACIC PROBE INSTRUMENTS AND THEY ALL TRACKED ACCURATELY. THIS DELAYED THE CASE BRIEFLY, BUT SURGEON CONTINUED AND TOOK A POST-OP SPIN WHICH SHOWED THE SCREWS WERE PLACED CORRECTLY AND THERE WAS NO HARM TO THE PATIENT. AFTER THE CASE THE MEDTRONIC NAVIGATION SYSTEM HARDWARE, SOFTWARE, AND INSTRUMENTS WERE TESTED AND ALL WERE FOUND ACCURATE AND FULLY FUNCTIONAL. C00140173. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2182510 MEDICREA DRIVER SCREWDRIVER HXX MEDICREA INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown