BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 4873561 · Received June 27, 2015

    Report

    Report Number
    1723170-2015-00756
    Event Type
    Injury
    Date Received
    June 27, 2015
    Date of Event
    May 29, 2015
    Report Date
    May 17, 2017
    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

    CORRECTION: IT WAS DISCOVERED ON 27-JAN-2016, THAT AN INCORRECT DATE WAS REFERENCED IN A PREVIOUS SUPPLEMENTAL 3500A SUBMISSION. THE REPORTED DATE OF 16-AUG-2016 WAS REPORTED INCORRECTLY AND SHOULD BE 16-AUG-2015.STATEMENT IN PREVIOUS SUPPLEMENTAL 3500A SUBMISSION SHOULD READ: ¿ON 30-JUN-2015, IT WAS NOTICED THAT A CODING ERROR IN MDR SUBMISSIONS FROM OUR FACILITY RESULTED IN THE MAUDE DATABASE INCORRECTLY CODING THE DEVICES RELATED TO OUR MDR SUBMISSIONS FROM 25-MAY-2015 TO 16-AUG-2015. THE DECISION TO WAIT UNTIL THE DATABASE WAS CORRECTED WAS MADE AFTER CONSULTATION WITH THE FDA AS ADVISED BY A CONSUMER SAFETY OFFICER WITH THE INFORMATION ANALYSIS BRANCH, DIVISION OF POST MARKET SURVEILLANCE, OFFICE OF SURVEILLANCE AND BIOMETRICS. AN IT SOLUTION WAS IMPLEMENTED ON 16-AUG-2015. THIS MDR WAS SUBMITTED TO CORRECT THE CODING ERROR. THERE IS NO NEW INFORMATION TO CHANGE THE PATIENT INFORMATION, EVENT DESCRIPTION AND/OR MANUFACTURER NARRATIVE THAT WAS PREVIOUSLY REPORTED.¿

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2015 A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED THE SURGEON FELT INACCURATE USING PROBES, THE SCREWS DID NOT BREACH. THE SURGEON FELT THE PROBE BREACHED AND DISCONTINUED THE USE OF THE NAVIGATION SYSTEM AT THAT TIME. THE SURGEON CONTINUED TO USE NON-NAVIGATED DRIVER AND SCREWS TO PROCEED. NO PARTS HAVE BEEN RECEIVED BY MANUFACTURER FOR ANALYSIS. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S STEALTHSTATION S7 SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE SPOKE WITH THE RESIDENT AFTERWARD WHO SAID IT WAS MOST LIKELY THEIR APPROACH INSTEAD OF THE MEDTRONIC SYSTEM WHICH CAUSED THE EVENT, BUT THIS COULDN'T BE CONFIRMED WITH THE SURGEON. THE AMOUNT OF INACCURACY WAS NOT KNOWN. THE MEDTRONIC REPRESENTATIVE CHECKED THE ACCURACY OF THE TACTILE PROBES AGAIN IN TWO CASES AND PERFORMED A MAINTENANCE ON BOTH TRAYS AVAILABLE, THE INSTRUMENTS FUNCTIONED PROPERLY AND WERE ACCURATE DURING ALL TESTING. UNABLE TO DUPLICATE REPORTED EVENT. UNABLE TO DETERMINE PROBABLE CAUSE WITHOUT FURTHER INFORMATION SINCE THE INSTRUMENTS TESTED OUT WITHOUT ISSUE.

    Additional Manufacturer Narrative · 1

    ON 30-JUN-2015, IT WAS NOTICED THAT A CODING ERROR IN MDR SUBMISSIONS FROM OUR FACILITY RESULTED IN THE MAUDE DATABASE INCORRECTLY CODING THE DEVICES RELATED TO OUR MDR SUBMISSIONS FROM 25-MAY-2015 TO 16-AUG-2016. THE DECISION TO WAIT UNTIL THE DATABASE WAS CORRECTED WAS MADE AFTER CONSULTATION WITH THE FDA AS ADVISED BY A CONSUMER SAFETY OFFICER WITH THE INFORMATION ANALYSIS BRANCH, DIVISION OF POST MARKET SURVEILLANCE, OFFICE OF SURVEILLANCE AND BIOMETRICS. AN IT SOLUTION WAS IMPLEMENTED ON 16-AUG-2016. THIS MDR WAS SUBMITTED TO CORRECT THE CODING ERROR. THERE IS NO NEW INFORMATION TO CHANGE THE PATIENT INFORMATION, EVENT DESCRIPTION AND/OR MANUFACTURER NARRATIVE THAT WAS PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    THE SURGEON HAS USED THE NAVIGATION SYSTEM SUCCESSFULLY, WITHOUT ANY ISSUES, IN SUBSEQUENT SURGERIES.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PATIENT WEIGHT PROVIDED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A L4-S1 FUSION SPINE PROCEDURE, THE SURGEON ALLEGED AN INACCURACY WITH TRACKING THE TACTILE PROBES. THE SURGEON WAS USING A PERCUTANEOUS PIN REFERENCE FRAME. THE SURGEON PLACED LEFT AND RIGHT SCREWS ON L4 BEFORE NOTING ANY ISSUE, HOWEVER, TACTILE PROBES APPEARED MORE MEDIAL THAT THEY WERE. THE SURGEON WAS USING NON-NAVIGATED SCREWS AND DRIVERS AND BASED ON WHAT HE HAD SEEN WITH THE TACTILE PROBES, THIS TECHNIQUE LED TO THE 2 SCREWS BREACHING THE PEDICLES LATERALLY. NO SPECIFIC MEASUREMENT WAS PROVIDED. IN TROUBLE-SHOOTING, IT WAS CONFIRMED THAT NAVIGATION OF THE PASSIVE PLANAR WAS COMPLETELY ACCURATE, ONLY PEDICLE PROBES WERE AFFECTED. NAVIGATION WAS DISCONTINUED AFTER A 20 MINUTE DELAY AND THE REMAINDER OF THE SCREWS WERE PLACED MANUALLY. A CONFIRMATION SPIN SHOWED SCREWS PLACED NORMALLY. THERE WAS NO IMPACT ON PATIENT OUTCOME. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S STEALTHSTATION S7 SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417268 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention