BEUDAMED
    FDA Adverse Event Other Summary report: N

    VECTORVISION FLUORO 3D

    MDR report key: 3012632 · Received March 15, 2013

    Report

    Report Number
    8043933-2013-00007
    Event Type
    Other
    Date Received
    March 15, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    PMA / PMN Number
    K070106
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A RISK TO THE PATIENT'S HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES, ALTHOUGH THERE IS NO INDICATION OF A SYSTEMATIC ERROR OR MALFUNCTION OF THE BRAINLAB DEVICE, THE CORRESPONDING BRAINLAB MEASURES TO REDUCE THIS ALREADY ANTICIPATED RISK TO BE AS LOW AS REASONABLY PRACTICABLE ARE IN PLACE, ACCORDING TO THE HOSPITAL, THERE IS NO INJURY OR NEGATIVE EFFECT TO THE PATIENT, AND THE OUTCOME OF THE SURGERY WAS SUCCESSFUL. THE VIRTUAL DISPLAY OF THE BRAINLAB NAVIGATION MIGHT NOT HAVE BEEN AS ACCURATE TO THE PATIENT ANATOMY AS DESIRED, POTENTIALLY CAUSED BY THE APPARENT/EXISTING MECHANICAL PROBLEM OF THE NON-BRAINLAB INTRA-OPERATIVE CT SCANNER (OF WHICH IMAGES WERE USED BY BRAINLAB NAVIGATION WITH AUTOMATIC IMAGE REGISTRATION), MOVEMENTS OF THE VERTEBRAS THAT COULD NOT BE COMPENSATED BY THE NAVIGATION SYSTEM, SINCE THE REFERENCE ARRAY WAS NOT ATTACHED ON THE BONE TO BE OPERATED ON. THE ACTUAL ACCURACY OF THE VIRTUAL DISPLAY OF THE BRAINLAB NAVIGATION WAS APPARENTLY NOT SUFFICIENTLY VERIFIED AS REQUIRED WITH THE CORRESPONDING AND AVAILABLE FUNCTIONALITIES OF THE BRAINLAB DEVICE. FOR THIS SPECIFIC CASE THE INVESTIGATION RESULTS COULD NEITHER CONFIRM NOR DISPROVE AN ACTUAL INACCURACY OF THE INFORMATION PROVIDED BY THE BRAINLAB NAVIGATION SYSTEM. BRAINLAB INTENDS TO OFFER ADDITIONAL TRAINING TO THIS HOSPITAL.

    Description of Event or Problem · 1

    A SPINAL SURGERY TO FUSE VERTEBRAS (L5-L2) HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION SOFTWARE, USING THE NAVIGATION SW APPLICATION FEATURE AUTOMATIC IMAGE REGISTRATION FOR IMAGES FROM A NON-BRAINLAB INTRA-OPERATIVE CT SCANNER. THE SURGEON PLACED K-WIRES INTO THE PEDICLES WITH THE AID OF A NAVIGATED NEEDLE (NON-BRAINLAB NEEDLE MANUALLY CALIBRATED TO USE WITH VIRTUAL DISPLAY BY BRAINLAB NAVIGATION). FOLLOWING THE PLACED K-WIRE, A PEDICLE SCREW WAS INSERTED IN L3 WITHOUT USE OF NAVIGATION. A 2D FLUOROSCOPY WAS PERFORMED AFTER THE L3 PEDICLE SCREW INSERTION, WHICH REVEALED THAT THIS SCREW HAD PROTRUDED THROUGH THE SUPERIOR PORTION OF VERTEBRAL BODY AND INTO THE DISC SPACE BETWEEN L2-L3. ACCORDING TO THE SURGEON, THE OTHER PLACED K-WIRES WERE NOT AT THE DESIRED POSITIONS. THE POSITIONS OF THE K-WIRES AND PEDICLE SCREWS WERE CORRECTED DURING THE SAME SURGERY. ACCORDING TO THE HOSPITAL, THERE IS NO INJURY OR NEGATIVE EFFECT TO THE PATIENT, AND THE OUTCOME OF THE SURGERY WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110534 VECTORVISION FLUORO 3D IMAGE GUIDED SURGERY SYSTEM/ STEREOT HAW BRAINLAB AG 22260 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other