BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINEASSIST SYSTEM

    MDR report key: 8906255 · Received August 19, 2019

    Report

    Report Number
    1723170-2019-04528
    Event Type
    Injury
    Date Received
    August 19, 2019
    Date of Event
    January 1, 2010
    Report Date
    August 19, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K073467
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. THE REPORTED EVENT WAS FROM THE FOLLOWING LITERATURE ARTICLE: SCHOENMAYR R, KIM I. WHY DO I USE AND RECOMMEND THE USE OF NAVIGATION? ARGOSPINE NEWS <(>&<)> JOURNAL. VOLUME 22 (4). DOI: 10.1007/S 12240-010-0031-1. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Description of Event or Problem · 1

    ABSTRACT: IMAGE GUIDED COMPUTER ASSISTED NAVIGATION HAS BEEN SUCCESSFULLY INCORPORATED INTO DAILY ROUTINE IN INTRACRANIAL SURGERY OVER THE LAST DECADE. THE VALUE OF SPINAL NAVIGATION, HOWEVER, STILL IS UNDER DISCUSSION. MANY SURGEONS FEEL SAFE WITH TRANSPEDICULAR SCREW PLACEMENT AND DO NOT SEE THE NECESSITY FOR NAVIGATIONAL SUPPORT. THERE ARE, HOWEVER, QUITE A FEW REPORTS ON VARYING NUMBERS OF COMPLICATIONS FROM MISPLACED SCREWS [1, 2, 5, 9, 11, 14]. THE MOST FREQUENT ARGUMENTS AGAINST ITS USE ARE: DIFFICULT HANDLING; INCREASED OPERATING TIME; INSUFFICIENT PRECISION; ADDITIONAL COSTS FOR IMAGING AND HARDWARE COMPONENTS. WHILE POTENTIAL NAVIGATION SYSTEM BENEFITS ARE REPORTED: SMALLER LESS INVASIVE APPROACHES OR PERCUTANEOUS TECHNIQUE AND THEREFORE QUICKER RECOVERY AFTER SPINAL SURGERY; GREATER ACCURACY DURING SURGERY REDUCING RISKS OF SCREW MISPLACEMENT AND DAMAGE TO NEURAL ELEMENTS; REDUCED SURGERY TIME; REDUCED RADIATION EXPOSURE [3, 4, 6, 7, 8, 10, 12, 13, 15]. WE HAVE EVALUATED SOME OF THE PARAMETERS OF INTEREST IN ORDER TO CLARIFY THE ROLE OF SPINAL NAVIGATION IN SPINAL TRANSPEDICULAR FIXATION. REPORTED EVENTS: 1. IN 2 CASES USING THE ROBOTIC GUIDANCE SYSTEM, REVISION SURGERIES HAD TO BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700845 SPINEASSIST SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC TPL0001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention