BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERBODY INSERTER CAPSTONE & CLYDESDALE

    MDR report key: 3801134 · Received May 8, 2014

    Report

    Report Number
    1723170-2014-00460
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 8, 2014
    Report Date
    November 10, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    OLO
    PMA / PMN Number
    K131425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RMA ISSUED. REPLACEMENT DEVICE SHIPPED TO SITE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR ANALYSIS.

    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.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION PROCEDURE, THE NAVIGATED CAGE INSERTER INSTRUMENT WAS DAMAGED. THE THREAD OF THE LEAD SCREW WAS DAMAGED AND WAS UNUSABLE AS THE SCREW COULD NOT BE CONNECTED TO THE CAGE. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277368 INTERBODY INSERTER CAPSTONE & CLYDESDALE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. 120613

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR