BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3113411 · Received May 15, 2013

    Report

    Report Number
    1723170-2013-00339
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER FURTHER EVALUATION OF THE DETAILS OF THIS CASE, SOFTWARE ENGINEERING DETERMINED THAT THE REFERENCE FRAME WAS NOT LOCATED CLOSE ENOUGH TO THE SURGICAL AREA OF INTEREST. INSTRUCTIONS FOR USE STATE, "FOR SPINAL PROCEDURES, SECURE THE FRAME AT THE VERTEBRAL LEVEL OF INTEREST TO ENSURE ACCURATE REGISTRATION AND NAVIGATION."

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION HAS NOT BEEN MADE AVAILABLE FROM THE SITE. FOLLOWING THIS EVENT, A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. ALL OF THE INSTRUMENTS TRACKED NORMALLY AND A SYSTEM CHECK-OUT SHOWED THAT THE NAVIGATION EQUIPMENT WAS FULLY FUNCTIONAL. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL. THERE WERE NO FURTHER ISSUES.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SURGEON WAS 5MM INACCURATE DURING SCREW PLACEMENT FOR A REVISION SCOLI SPINE PROCEDURE. THE PATIENT REFERENCE FRAME WAS PLACED AT L5 AND INACCURACY OCCURRED AT T9-T10. A NAVIGATED SPIN WAS ACQUIRED WITH FRAME PLACED AT L5. SCREW PLACEMENT WAS ACCURATE AT LEVELS INFERIOR TO T9-T10. ANOTHER SPIN WAS ACQUIRED TO CONFIRM THE SCREW PLACEMENT. TWO SCREWS AT THE T9-T10 LEVELS WERE FOUND TO HAVE BREECHED THE PEDICLE WALL MEDIALLY AND WERE ADJUSTED. THE REMAINDER OF THE PROCEDURE WAS COMPLETED WITHOUT NAVIGATION. IT WAS REPORTED THAT THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214094 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention O-ARM 1000 IMAGING SYSTEM