{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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SITE WAS GIVEN INSTRUCTIONS TO ADJUST THE CONTRAST OF THE CT AND SMOOTH OUT THE 3D RECONSTRUCTION. LATER IT WAS REPORTED 2 MORE REGISTRATIONS HAD FAILED DUE TO 'INSUFFICIENT ACCURACY' AND ON A THIRD, THE SCREEN WENT BLACK AND THE ARM WAS LOCKED WHILE ATTEMPTING TO FIX AN INITIAL POINT. SITE WAS GIVEN INSTRUCTIONS TO PERFORM THE PROCESS OF CONFIRMING WHICH CT SCAN WAS USED FOR THE 3D RECONSTRUCTION AND REGISTRATION WAS COMPLETED ALL THE WAY THROUGH VERIFICATION. WHEN THE DISTANCE SENSOR WAS DRIVEN TO THE TRAJECTORY, THE SURGEON WAS NOT HAPPY WITH WHERE THE ENTRY POINT LOOKED ON THE PATIENT'S HEAD. HE SAID THAT THE PATIENT WAS OVERWEIGHT AND HAD A LOT OF MOVABLE SKIN. THE SURGEON MENTIONED TRYING TO SWITCH TO BONE FIDUCIAL REGISTRATION, HOWEVER DUE TO SUPPLY ISSUES WITH THE BONE FIDUCIALS, THE CASE WAS ABORTED AND WILL BE RESCHEDULED." }, { "mdr_text_key": "319128176", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A REVIEW OF DHR FOR THE SUBJECT DEVICE WITHIN SIX MONTHS HAS DETERMINED THAT THERE ARE NOT ANY RECORDED ISSUES OR INTERVENTIONS WHICH MAY BE RELATED TO OR MAY HAVE AN IMPACT ON THE REPORTED EVENT. A REVIEW OF THE COMPLAINTS THAT OCCURRED IN THE PAST 12 MONTHS PRIOR TO THE COMPLAINT NOTIFICATION DATE FOR THIS DEVICE SERIAL NUMBER DETERMINED THAT THERE WAS NO TREND IDENTIFIED. A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND CONFIRMED THAT ALTHOUGH IT PROVIDED CORRECT RESULTS, THE REGISTRATION DID NOT PERMIT TO GET A SATISFACTORY REGISTRATION ACCURACY. THE VERIFICATION STEP AND THE VERIFICATION OF THE ENTRY POINT WITH THE LASER ARE ELEMENTS WHICH PERMITTED TO CHECK THE REGISTRATION ACCURACY. THE PATIENT FOLDER WAS NEVER PROVIDED, THEREFORE THE ROOT CAUSE FOR THE ISSUE REMAINS UNKNOWN. HOWEVER, THE SURGEON NOTED THAT THE PATIENT HAD A LOT OF MOVABLE SKIN AND THE AUTOMATIC REGISTRATION IS BASED ON SKIN SURFACE MATCHING. THEREFORE, IT IS ASSUMED THAT THE REGISTRATION METHOD WAS NOT ADAPTED TO THIS PATIENT. BASED ON THE INVESTIGATION PERFORMED, IT IS ASSUMED THAT THE REGISTRATION METHOD WAS NOT ADAPTED TO THE PATIENT ANATOMY. AT SOME POINT DURING THE PROCEDURE, A SOFTWARE CRASH OCCURRED WHICH MIGHT BE DUE TO A SYSTEM MEMORY ERROR, BUT ITS ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED WITH AVAILABLE DATA." }, { "mdr_text_key": "140160709", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. (B)(4)." }, { "mdr_text_key": "140160710", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A SURGERY THE FIRST REGISTRATION FAILED. SITE WAS GIVEN INSTRUCTIONS TO ADJUST THE CONTRAST OF THE CT AND SMOOTH OUT THE 3D RECONSTRUCTION. LATER IT WAS REPORTED 2 MORE REGISTRATIONS HAD FAILED DUE TO 'INSUFFICIENT ACCURACY' AND ON A THIRD, THE SCREEN WENT BLACK AND THE ARM WAS LOCKED WHILE ATTEMPTING TO FIX AN INITIAL POINT. SITE WAS GIVEN INSTRUCTIONS TO PERFORM THE PROCESS OF CONFIRMING WHICH CT SCAN WAS USED FOR THE 3D RECONSTRUCTION AND REGISTRATION WAS COMPLETED ALL THE WAY THROUGH VERIFICATION. WHEN THE DISTANCE SENSOR WAS DRIVEN TO THE TRAJECTORY, THE SURGEON WAS NOT HAPPY WITH WHERE THE ENTRY POINT LOOKED ON THE PATIENT'S HEAD. HE SAID THAT THE PATIENT WAS OVERWEIGHT AND HAD A LOT OF MOVABLE SKIN. THE SURGEON MENTIONED TRYING TO SWITCH TO BONE FIDUCIAL REGISTRATION, HOWEVER DUE TO SUPPLY ISSUES WITH THE BONE FIDUCIALS, THE CASE WAS ABORTED AND WILL BE RESCHEDULED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "11/24/2020" } ] }