BEUDAMED
    FDA Adverse Event Other Summary report: N

    VECTORVISION NAVIGATION SW SPINE

    MDR report key: 2111083 · Received May 23, 2011

    Report

    Report Number
    8043933-2011-00007
    Event Type
    Other
    Date Received
    May 23, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 26, 2011
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    PMA / PMN Number
    K053159
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DESPITE. ACCORDING TO THE HOSP, THERE WAS NO NEGATIVE CLINICAL EFFECT FOR THE PT, THERE HAS BEEN NO PT OR USER INJURY REPORTED AT THIS HOSP NOR REPORTED BY ANY OTHER HOSP, THERE IS NO INDICATION OF A GENERAL QUALITY OR PERFORMANCE ISSUE WITH THE BRAINLAB DEVICE, ACCORDING BRAINLAB MEASURES FOR THE ALREADY ANTICIPATED POTENTIAL RISK ARE IN PLACE, A RISK TO PT HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES IN THIS ISOLATED CASE. FOLLOWING THE REGISTRATION BY THE USER, THE BRAINLAB NAVIGATION SOFTWARE FOUND AND DISPLAYED A MATCH, THAT DID NOT REFLECT THE ACTUAL POSITION OF THE VERTEBRA. THIS POTENTIAL RISK IS ALREADY ANTICIPATED BY THE BRAINLAB DESIGN: THE USER IS ASKED TO VERIFY THE FOUND MATCH ON A VERIFICATION PAGE AFTER REGISTRATION. IN THIS SPECIFIC CASE THE USER VERIFICATION OF THE FOUND MATCH INSIDE THE BRAINLAB NAVIGATION SOFTWARE WAS APPARENTLY NOT SUFFICIENTLY PERFORMED TO REVEAL THE SITUATION. BRAINLAB INTENDS TO OFFER ADDITIONAL TRAINING TO THIS HOSP. SINCE THERE IS NO INDICATION OF A GENERAL QUALITY OR PERFORMANCE ISSUE WITH THE BRAINLAB DEVICE, THERE ARE NO FURTHER CORRECTIVE AND PREVENTIVE ACTIONS INTENDED AT THIS POINT OF TIME.

    Description of Event or Problem · 1

    AFTER PLACING A SCREW IN THE PT'S SPINE USING THE BRAINLAB SPINE NAVIGATION SOFTWARE, THE USER REPORTED THAT THE ACTUAL POSITION OF THE SCREW DEVIATED FROM ITS INTENDED POSITION. THE USER CORRECTED THE POSITION OF THE SCREW DURING THE SAME SURGERY. ACCORDING TO THE HOSPITAL, THERE WAS NO NEGATIVE CLINICAL EFFECT FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VECTORVISION NAVIGATION SW SPINE IMAGE GUIDED SURGERY SYSTEM / STEREOTAXIC HAW BRAINLAB AG 22060D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other