BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAV LUMBAR PROBE TIP

    MDR report key: 2884025 · Received December 21, 2012

    Report

    Report Number
    1723170-2012-00763
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE TIP OF THE INSTRUMENT IS VISIBLY BENT. A REPLACEMENT DEVICE WAS SENT TO THE SITE ON (B)(4) 2012.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THE NAVLOCK LUMBAR PROBE BENT ON THE PATIENT'S BONE DURING A SPINAL FUSION SURGERY. THEY WERE ABLE TO COMPLETE THE CASE WITH THE INSTRUMENTS THEY HAD, THEY DO NOT HAVE ANY BACKUPS. NO NEGATIVE IMPACT TO THE PATIENT OUTCOME WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAV LUMBAR PROBE TIP NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 100213

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR