BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2862072 · Received December 7, 2012

    Report

    Report Number
    1723170-2012-00693
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    May 16, 2013
    Report Date
    May 16, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 WAS SUBMITTED IN ERROR, PLEASE DISREGARD. THE INITIAL MDR HAD THE "MALFUNCTION" FIELD SELECTED, BUT SHOULD HAVE HAD THE "SERIOUS INJURY" FIELD SELECTED INSTEAD.

    Additional Manufacturer Narrative · 1

    BASED ON FURTHER INVESTIGATION, THE DEVICE RESPONSIBLE FOR THE REPORTED EVENT WAS CHANGED FROM THE AWL/PROBE/TAP DRIVER TO THE STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM. NO CONCLUSIVE ROOT CAUSE COULD BE DETERMINED RELATED TO THE EVENT. IN ADDITION, THE APT DRIVER WAS RULED OUT AS A CONTRIBUTING FACTOR AS THE FAILURE MODE WOULD ONLY RESULT IN POTENTIAL INACCURACY DEPTH-WISE NOT SUPERIOR/INFERIOR OR MEDIAL LATERAL.

    Additional Manufacturer Narrative · 1

    THE COMPUTER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. FINDINGS INCLUDE THE DEVICE WAS FOUND TO BE FULLY FUNCTION AND THE SYSTEM DID NOT CAUSE THE EVENT.

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE FOLLOWED-UP WITH A HOSPITAL REPRESENTATIVE, SCRUB TECH, AFTER THE SURGERY WAS COMPLETED. IT WAS REPORTED THAT THE SURGEON PLACED ONE SCREW WITHOUT ISSUE, THEN WENT TO AN ADJACENT PEDICLE AND PROCEEDED TO PLACE THE SECOND SCREW WITH THE APT, BUT HAD A CONCERN ABOUT PLACEMENT. THE SURGEON TOOK A SPIN WITH THE ISO-C AND FOUND THE SCREW HAD BEEN PLACED IN THE BOTTOM OF THE PEDICLE NEAR THE DISC SPACE, THE SURGEON REPOSITIONED IT. THE REMAINDER OF THE INSTRUMENTS WERE ACCURATE, HOWEVER, THE SURGEON OPTED NOT TO USE NAVIGATION TO COMPLETE THE PROCEDURE SINCE THE APT COULD NOT BE USED. RMA ISSUED. REPLACEMENT INSTRUMENT SHIPPED TO SITE (B)(4) 2012. MEDTRONIC EVALUATION OF THE SUSPECT DEVICE FINDS THE POST HAS BACKED OUT APPROXIMATELY 1/8 INCH BUT IS NO LONGER LOOSE. THE DRIVER IS OTHERWISE FUNCTIONAL ACCEPTING TOOLS AND HANDLE WITHOUT ISSUE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A SPINE PROCEDURE, THE SITE REQUESTED A REPLACEMENT AWL/PROBE/TAP (APT) DRIVER. NO DETAILS WERE PROVIDED AT THE TIME OF THE SURGERY. THE PROCEDURE WAS COMPLETED WITH NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. TREON 111103

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention