{ "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. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "N", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "3009185973-2018-00191", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20180704", "manufacturer_address_2": "", "pma_pmn_number": "PK101791", "date_of_event": "20180702", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "HEALTH PROFESSIONAL", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20180704", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "503829", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20180704", "brand_name": "ROSA SURGICAL DEVICE", "generic_name": "COMPUTER-ASSISTED SURGICAL DEVICE", "manufacturer_d_name": "MEDTECH SA", "manufacturer_d_address_1": "ZAC EUREKA", "manufacturer_d_address_2": "900 RUE DU MAS DE VERCHANT", "manufacturer_d_city": "MONTPELLIER, LANGUEDOC-ROUSSILLON", "manufacturer_d_state": "", "manufacturer_d_zip_code": "34000", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "FR", "manufacturer_d_postal_code": "34000", "device_operator": "HEALTH PROFESSIONAL", "model_number": "ROSA 2.5.8", "catalog_number": "N/A", "lot_number": "2.5.8.4", "other_id_number": "N/A", "device_availability": "Yes", "device_report_product_code": "HAW", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Neurological Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Computer Software Problem", "Computer Software Problem" ], "reporter_state_code": "GA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/12/2018", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250801", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20180704", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available", "No Code Available" ] } ], "distributor_city": "", "date_report": "20181227", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7662126", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20180702", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "113158994", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "113158995", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON THE (B)(6) 2018, A PATIENT WAS BROUGHT IN FOR BILATERAL SEEG IMPLANTATION, AND WHEN THE CRW FRAME WOULD NOT FIT THE PATIENT¿S HEAD DUE TO THE SIZE OF THE HEAD, A MAYFIELD WAS USED AND ROSA WAS ATTACHED. THE PATIENT WAS REGISTERED, BUT WAS TOO FAR FROM THE ROBOT BASE TO REACH SOME OF THE TRAJECTORIES, SO THE PATIENT WAS REPOSITIONED AND REGISTERED AGAIN. THIS TIME, ALL TRAJECTORIES WERE ACCESSIBLE, BUT UPON VERIFICATION, THE POINTS ON THE LEFT SIDE OF THE HEAD WERE ABOUT 6MM AWAY FROM THE SKIN ON THE CT SCAN. REGISTRATION WAS CANCELED AND RESTARTED. THIS TIME A DIFFERENT PORTION OF THE LEFT TEMPLE WAS SCANNED FURTHER AWAY FROM THE MAYFIELD PIN, AND THE REGISTRATION COULD NOT BE COMPUTED. REGISTRATION WAS ATTEMPTED AGAIN, WITH ANOTHER PORTION OF THE TEMPLE SCANNED. THE VERIFICATION RESULTS WERE THE SAME AS BEFORE, WITH ALL OF THE POINTS VERIFIED, EXCEPT FOR THE POINTS ON THE LEFT SIDE OF THE HEAD. ONE LAST REGISTRATION WAS DONE AND THE LEFT TEMPORAL SCAN WAS SKIPPED. THE VERIFICATION SHOWED THE SAME RESULTS AS BEFORE. THIS PATIENT WAS EXTREMELY OVERWEIGHT AND IT WAS DECIDED THAT THERE WAS TOO MUCH RELAXED SKIN AND MUSCLE THAT WAS SHIFTING AROUND, SO THE FACE NO LONGER MATCHED THE CT SCAN BEING USED FOR REGISTRATION. AT THIS POINT IT WAS DECIDED THAT BONE FIDUCIALS WOULD BE PUT IN AND A NEW CT SCAN TAKEN. ONCE THE CT WITH THE FIDUCIALS WAS UPLOADED, THE CASE CONTINUED ON AS PLANNED. IN TOTAL THIS DELAYED THE CASE APPROXIMATELY 3.5 HOURS." }, { "mdr_text_key": "312101377", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON THE (B)(6) 2018, A PATIENT WAS BROUGHT IN FOR BILATERAL SEEG IMPLANTATION, AND WHEN THE CRW FRAME WOULD NOT FIT THE PATIENT¿S HEAD DUE TO THE SIZE OF THE HEAD, A MAYFIELD WAS USED AND ROSA WAS ATTACHED. THE PATIENT WAS REGISTERED, BUT WAS TOO FAR FROM THE ROBOT BASE TO REACH SOME OF THE TRAJECTORIES, SO THE PATIENT WAS REPOSITIONED AND REGISTERED AGAIN. THIS TIME, ALL TRAJECTORIES WERE ACCESSIBLE, BUT UPON VERIFICATION, THE POINTS ON THE LEFT SIDE OF THE HEAD WERE ABOUT 6MM AWAY FROM THE SKIN ON THE CT SCAN. REGISTRATION WAS CANCELED AND RESTARTED. THIS TIME A DIFFERENT PORTION OF THE LEFT TEMPLE WAS SCANNED FURTHER AWAY FROM THE MAYFIELD PIN, AND THE REGISTRATION COULD NOT BE COMPUTED. REGISTRATION WAS ATTEMPTED AGAIN, WITH ANOTHER PORTION OF THE TEMPLE SCANNED. THE VERIFICATION RESULTS WERE THE SAME AS BEFORE, WITH ALL OF THE POINTS VERIFIED, EXCEPT FOR THE POINTS ON THE LEFT SIDE OF THE HEAD. ONE LAST REGISTRATION WAS DONE AND THE LEFT TEMPORAL SCAN WAS SKIPPED. THE VERIFICATION SHOWED THE SAME RESULTS AS BEFORE. THIS PATIENT WAS EXTREMELY OVERWEIGHT AND IT WAS DECIDED THAT THERE WAS TOO MUCH RELAXED SKIN AND MUSCLE THAT WAS SHIFTING AROUND, SO THE FACE NO LONGER MATCHED THE CT SCAN BEING USED FOR REGISTRATION. AT THIS POINT IT WAS DECIDED THAT BONE FIDUCIALS WOULD BE PUT IN AND A NEW CT SCAN TAKEN. ONCE THE CT WITH THE FIDUCIALS WAS UPLOADED, THE CASE CONTINUED ON AS PLANNED. IN TOTAL THIS DELAYED THE CASE APPROXIMATELY 3.5 HOURS." }, { "mdr_text_key": "312101378", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE LASER REGISTRATION WAS NOT ACCURATE. A DHR REVIEW AND A COMPLAINT HISTORY REVIEW WERE PERFORMED AND DID IDENTIFY 1 SIMILAR COMPLAINT TO THE EVENT. A FULL ANALYSIS OF DATA LOGS DETERMINED THAT THE EXAM WAS NOT MATCHING PATIENT ACTUAL MORPHOLOGY AND THE WORKFLOW OF THE REGISTRATION¿S FIRST STEP WAS NOT EXECUTED PROPERLY : REFERENCE POINTS MARKED ON IMAGES MUST NOT BE CORRECTED WITHOUT ALSO CORRECTING THE CORRESPONDING ROBOT POINTS WITH THE LASER. THIS BAD PRACTICE WAS PERFORMED EACH TIME THE USER WANTED TO ADJUST POINTS TOGETHER. ALSO, THREE TIMES, THE ERROR MESSAGE ON THE SURFACE MATCHING VERIFICATION INTERFACE AFTER THE AUTOMATIC AND MANUAL SCAN WARNED THE USER THAT THE REGISTRATION WAS NOT SATISFACTORY. AT THIS MOMENT THE REGISTRATION SHOULD HAVE BEEN RESTARTED BUT THE VERIFICATION WAS RESUMED. IFU REVIEW INDICATES THAT THE IFU PROVIDES INDICATIONS REGARDING THE POINTS COLLECTION AND THEIR ADJUSTMENTS AND INFORMATION ABOUT THE REQUIRED REGISTRATION VERIFICATION. THEREFORE THE ROOT CAUSE OF THE ISSUE IS IDENTIFIED AS USE ERROR. (B)(4)." } ], "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": "12/27/2018" } ] }