BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 1991096 · Received February 11, 2011

    Report

    Report Number
    1723170-2011-00116
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO ALLEGATION OF INACCURACY AGAINST THE MEDTRONIC PRODUCTS INVOLVED. MEDTRONIC NAVIGATION IS IN PROCESS OF INVESTIGATING THIS EVENT FURTHER.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A CERVICAL SPINE CASE, WITH THE O-ARM, THE SURGEON WAS USING THE CRANIAL FRAME ON THE MAYFIELD CLAMP. THE MEDTRONIC REP REPORTED THAT THE STARBURST ON THE NON-MEDTRONIC MAYFIELD DID NOT FULLY SEAT AND THAT ONE OF THE SURGEONS TAPED IT. THE MEDTRONIC REP CAUTIONED THE SURGEON THAT IF THE PT SLIPPED IN THE MAYFIELD THEN ACCURACY WOULD BE OFF, HOWEVER, THE SURGEON PROCEEDED USING THE TAPED MAYFIELD. AS THEY FELT INACCURATE THEY TOOK A SECOND AND A THIRD SPIN WITH THE O-ARM, AFTER WHICH, THEY WERE SATISFIED AND COMPLETED THE CASE USING NAVIGATION. THEY TOOK A POST-OP SPIN WITH THE O-ARM AND THE MEDTRONIC REP REPORTED THE SURGEON BACKED-OUT AT LEAST ONE SCREW AND RE-SEATED IT. AFTER THIS THE SURGEON WAS SATISFIED AND CLOSED THE PT. THERE WAS NO NEGATIVE OUTCOME TO THE PT.

    Devices

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

    Patients

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