BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 5737188 · Received June 20, 2016

    Report

    Report Number
    1723170-2016-01153
    Event Type
    Injury
    Date Received
    June 20, 2016
    Date of Event
    May 24, 2016
    Report Date
    June 20, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). FOLLOWING THE PROCEDURE, THE MEDTRONIC REPRESENTATIVE IN ATTENDANCE TOOK SOME SPINS AND CHECKED ACCURACY ON ALL TRACKERS AND BELIEVES THIS INACCURACY WAS USER ERROR. ON 05/24/2016 A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. REPORTED ISSUE COULD NOT BE REPLICATED. ON 06/02/2016 SOFTWARE ANALYSIS WAS UNABLE TO DETERMINE PROBABLE CAUSE WITH THE INFORMATION PROVIDED. NO PARTS WERE REPLACED. NO PARTS HAVE BEEN RECEIVED BY MANUFACTURER FOR ANALYSIS. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, THE SURGEON ALLEGED AN INACCURACY IN SCREW PLACEMENT. ESTIMATED INACCURACY WAS BETWEEN 2-4 MILLIMETERS IN THE MEDIAL ORIENTATION. THE LEFT SIDE SCREWS WERE PLACED MEDIAL AND THE THREADS WERE BREACHING INTO THE SPINAL CANAL. THE SURGEON NOTED THAT BONE FRAGMENTS HAD PUSHED INTO THE SPINAL CANAL. AFTER DOUBLE-CHECKING THE SCANS BEFORE SCREW PLACEMENT. THE MEDTRONIC REPRESENTATIVE NOTED A MICROFRACTURE IN THE PEDICLE WHERE THE BONE FRAGMENT BREACHED INTO THE SPINAL CANAL. THE SURGEON HAD ALSO PLACED THE PERCUTANEOUS PIN ON THE OUTER MEDIAL EDGE OF ILIAC CREST AND NOT ACTUALLY ANCHOR IT IN BONE. THE SURGEON REMOVED ALL BONE FRAGMENTS FROM THE SPINAL CANAL. THEY RE-ATTACHED A SPINE CLAMP AND FRAME AND COMPLETED THE SURGERY WITHOUT ISSUE. THE ONLY NAVIGATED INSTRUMENTS USED IN THIS PROCEDURE WERE THE PASSIVE PLANAR PROBE, THE UNIVERSAL DRILL GUIDE (UDG), AND A PEDICLE ACCESS KIT (PAK) NEEDLE. SITE BROUGHT IN C-ARM TO TEST RE-PLACEMENT OF SCREWS. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. DELAY IN THERAPY WAS GREATER THAN ONE HOUR BEFORE CONTINUING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389936 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention