BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPINE & TRAUMA 3D

    MDR report key: 3254192 · Received July 26, 2013

    Report

    Report Number
    8043933-2013-00023
    Event Type
    Other
    Date Received
    July 26, 2013
    Date of Event
    June 24, 2013
    Report Date
    July 3, 2013
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    PMA / PMN Number
    K070106
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE AN ARTERIAL BLEEDING OF THE PT OCCURRED IN THIS SPECIFIC CASE, A RISK TO THE PT'S HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES, ALTHOUGH: THERE IS NO INDICATION OF A MALFUNCTION OR DEFECT OR SYSTEMATIC ERROR OF THE BRAINLAB DEVICE, THE CORRESPONDING MEASURES TO REDUCE THIS ALREADY ANTICIPATED RISK AS LOW AS REASONABLY PRACTICABLE ARE IN PLACE; ACCORDING TO THE HOSPITAL, THERE IS NO NEGATIVE EFFECT TO THE PT, AND THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL. THE INFO DISPLAYED IN THE BRAINLAB NAVIGATION SYSTEM MIGHT NOT HAVE BEEN AS ACCURATE TO THE PT ANATOMY AND/OR TO THE ACTUAL INSTRUMENT AS DESIRED FOR THIS SPECIFIC PROCEDURE. THE MOST LIKELY ROOT CAUSE IS A COMBINATION OF: LESS THAN IDEAL INSTRUMENT CALIBRATION, LEADING TO A POTENTIALLY INACCURATE DISPLAY OF THESE INSTRUMENTS; A DE-CALIBRATED C-ARM, LEADING TO A POTENTIALLY INACCURATE MATCHING OF THE PT SCAN WITH THE ACTUAL PT ANATOMY. THIS POTENTIAL INACCURACY WAS APPARENTLY NOT DETECTED WITH THE CORRESPONDING VERIFICATION FUNCTIONALITIES THAT ARE AVAILABLE. THERE IS NO INDICATION OF AN ERROR OR MALFUNCTION OF THE BRAINLAB DEVICE. THERE ARE ALREADY ACCORDING MEASURES IN PLACE TO REDUCE THIS RISK TO BE S LOW AS REASONABLY PRACTICABLE. BRAINLAB INTENDS TO OFFER ADDITIONAL TRAINING TO THIS HOSPITAL.

    Description of Event or Problem · 1

    A SPINAL SURGERY FOR A STABILIZATION OF TWO VERTEBRAS (C1/C2) WAS PLANNED TO BE PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION SYSTEM. DURING THE PROCEDURE, THE SURGEON: PERFORMED AN AUTOMATIC IMAGE REGISTRATION, WHICH AUTOMATICALLY MATCHES THE CURRENT PT SCAN WITH THE ACTUAL PATIENT ANATOMY; VERIFIED THE RESULTS OF THE REGISTRATION ACCORDINGLY; CALIBRATED A DRILL FOR USE WITH NAVIGATION, IN COMBINATION WITH A NON-NAVIGATED DRILL GUIDE; PREPARED THE CANAL FOR THE PEDICLE SCREW ON THE LEFT SIDE OF C2, USING THE DRILL. THE DRILLING CAUSED A BLEEDING OF THE ARTERIA VERTEBRALIS, SINCE THE ENTRY POINT WAS MORE LATERAL THAN INTENDED. THE BLEEDING COULD BE STOPPED INTRAOPERATIVELY BY MEDICAL/SURGICAL INTERVENTION. THE SURGEON DID NOT FURTHER USE THE AID OF NAVIGATION BUT PLACED THE REMAINING PEDICLE SCREWS WITH CONVENTIONAL TECHNIQUES. THE SURGERY COULD BE COMPLETED SUCCESSFULLY. ACCORDING TO THE HOSPITAL, THERE ARE NO NEGATIVE CLINICAL EFFECTS REMAINING FOR THIS SPECIFIC PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351061 SPINE & TRAUMA 3D IMAGE GUIDED SURGERY SYSTEM/STEREOT. HAW BRAINLAB AG 22260 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other