{ "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": "3009185973-2019-00210", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190620", "manufacturer_address_2": "", "pma_pmn_number": "K151359", "date_of_event": "20190521", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE 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": "20190620", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "511757", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190620", "brand_name": "ROSA BRAIN", "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 BRAIN", "catalog_number": "N/A", "lot_number": "3.0.0.21", "other_id_number": "", "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": [ "Imprecision", "Imprecision" ], "reporter_state_code": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/21/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250729", "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": "20190620", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available", "No Code Available" ] } ], "distributor_city": "", "date_report": "20200305", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8715154", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190521", "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": "148529122", "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": "148529123", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A FIELD SERVICE ENGINEER ASSISTED AN SEEG CASE ON (B)(6) 2019. THE CASE WAS A CONTINUATION OF A PREVIOUS SEEG CASE THAT WAS PERFORMED ON (B)(6) 2019. THE SURGEON WANTED TO ADD FOUR MORE ELECTRODES TO THE PREVIOUS PLAN. AFTER THE SURGEON OBTAINED A CT THE MORNING OF SURGERY AND MERGED IT TO THE MR FROM THE ORIGINAL PLAN, IT WAS NOTICED THAT A LOT OF ELECTRODES WERE NOT ACCURATELY PLACED FROM THE ORIGINAL SURGERY (THE BOLT BEING A FEW MM'S OFF FROM THE PROJECTED ENTRY POINT). THE MERGE SEEMED TO BE ADEQUATE, AND THERE WERE SOME ELECTRODES THAT APPEARED TO BE ACCURATELY PLACED. AFTER DISCUSSING WITH THE SURGEON, THE ELECTRODES THAT WERE ACCURATELY PLACED WERE THE FIRST ELECTRODES THAT WERE INSERTED DURING THE PREVIOUS SURGERY, AND THE INACCURATE ONES WERE PLACED AFTER THOSE. IT WAS ALSO DISCUSSED THAT SINCE THE MERGE LOOKED ACCURATE AND THE FIRST ELECTRODES THAT WERE PLACED WERE ACCURATE, A HEAD SHIFT DURING THE SURGERY COULD HAVE POSSIBLY CAUSED THE INACCURACY FOR THE REMAINING ELECTRODES. THE DISCUSSION DELAYED SURGERY ABOUT 10 MINUTES, AND THEN IT WAS DECIDED TO MOVE FORWARD WITH ADDING THE ADDITIONAL ELECTRODES. THERE WERE NO OTHER ISSUES EXPERIENCED DURING THE CASE." }, { "mdr_text_key": "317257329", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT MULTIPLE ELECTRODES WERE NOT ACCURATELY PLACED. THE DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. A DEVICE PREVENTIVE MAINTENANCE WAS PERFORMED THREE DAYS AFTER THAT THE IMPRECISION WAS NOTICED, AND ALL TESTS WERE PASSED. A REVIEW OF THE LOG FILES AND OF THE PATIENT FOLDER FROM THE SUBJECT EVENT WAS PERFORMED. ANALYSIS OF POST-OPERATIVE FUSION CONFIRMED THAT NINE OUT OF THE THIRTEEN ELECTRODES IMPLANTED HAD BEEN INSERTED BETWEEN 2.16 MM AND 3.34 MM AWAY FROM THEIR PLANNED ENTRY POINTS. THE INACCURACY MIGHT HAVE BEEN PROVOKED BY THE IMAGE FUSION QUALITY OF PRE-OPERATIVE AND POST-OPERATIVE FUSIONS AND/OR BY AN UNDETECTED HEAD SHIFT AFTER THE REGISTRATION. NONE OF THESE TWO HYPOTHESES COULD BE CONFIRMED WITH THE AVAILABLE INFORMATION, AND THE ROOT CAUSE FOR THE INACCURACY CANNOT BE DETERMINED. IT WAS NOTED THAT THE SURGEON BELIEVES THAT THE ELECTRODES WERE MOST LIKELY DEVIATED AS A RESULT OF A PATIENT¿S HEAD MOVEMENT. THE SURGEON WHO WAS OPERATING THE DEVICE WAS TRAINED TO ITS USE AND EXPERIENCED. DURING THE INVESTIGATION IT WAS ALSO NOTED THAT A KNOWN SOFTWARE ANOMALY OCCURRED, BUT WITHOUT ANY LINK TO THE IMPRECISION." }, { "mdr_text_key": "317257330", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A FIELD SERVICE ENGINEER ASSISTED AN SEEG CASE ON 21-MAY-2019. THE CASE WAS A CONTINUATION OF A PREVIOUS SEEG CASE THAT WAS PERFORMED ON 14-MAY-2019. THE SURGEON WANTED TO ADD FOUR MORE ELECTRODES TO THE PREVIOUS PLAN. AFTER THE SURGEON OBTAINED A CT THE MORNING OF SURGERY AND MERGED IT TO THE MR FROM THE ORIGINAL PLAN, IT WAS NOTICED THAT A LOT OF ELECTRODES WERE NOT ACCURATELY PLACED FROM THE ORIGINAL SURGERY (THE BOLT BEING A FEW MM'S OFF FROM THE PROJECTED ENTRY POINT). THE MERGE SEEMED TO BE ADEQUATE, AND THERE WERE SOME ELECTRODES THAT APPEARED TO BE ACCURATELY PLACED. AFTER DISCUSSING WITH THE SURGEON, THE ELECTRODES THAT WERE ACCURATELY PLACED WERE THE FIRST ELECTRODES THAT WERE INSERTED DURING THE PREVIOUS SURGERY, AND THE INACCURATE ONES WERE PLACED AFTER THOSE. IT WAS ALSO DISCUSSED THAT SINCE THE MERGE LOOKED ACCURATE AND THE FIRST ELECTRODES THAT WERE PLACED WERE ACCURATE, A HEAD SHIFT DURING THE SURGERY COULD HAVE POSSIBLY CAUSED THE INACCURACY FOR THE REMAINING ELECTRODES. THE DISCUSSION DELAYED SURGERY ABOUT 10 MINUTES, AND THEN IT WAS DECIDED TO MOVE FORWARD WITH ADDING THE ADDITIONAL ELECTRODES. THERE WERE NO OTHER ISSUES EXPERIENCED DURING THE CASE." } ], "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": "03/05/2020" } ] }