{ "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": "3009185973-2018-00227", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20180817", "manufacturer_address_2": "", "pma_pmn_number": "PK101791", "date_of_event": "20180806", "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": "20180817", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "633431", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20180817", "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": "ROSA", "lot_number": "2.5.8.4", "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": [ "Appropriate Device Problem Term/Code Not Available", "Appropriate Device Problem Term/Code Not Available" ], "reporter_state_code": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/08/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250821", "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": "20180817", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage, Cerebral", "Hemorrhage, Cerebral" ] } ], "distributor_city": "", "date_report": "20190122", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7792786", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20180809", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Inspection" ], "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": "117442889", "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": "117442890", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THREE DAYS AFTER SURGERY, THE NEUROSURGERY FELLOW NOTIFIED A REPRESENTATIVE OF MEDTECH, THE CST, THAT THE PATIENT HAD A HEMORRHAGE AND WAS IN THE INTENSIVE CARE UNIT. THE FELLOW BELIEVED HIGH BLOOD PRESSURE DURING SURGERY MAY HAVE PLAYED A ROLE AND INDICATED THAT BLOOD WAS PRESENT ON LEFT SIDE, WHERE ONLY THREE ELECTRODES WERE PLACED, DESPITE THE HIGHER CONCENTRATION OF ELECTRODES ON THE RIGHT SIDE. ELECTRODES FOR TRAJECTORIES ¿LA¿ AND ¿LPH¿ APPEAR BENT BUT ACCURATE, AND TRAJECTORY ¿LAH¿ APPEARS 2 MILLIMETERS DEEP. INACCURATE ELECTRODE PLACEMENTS ON THE RIGHT SIDE LIKELY DID NOT CONTRIBUTE TO THIS ISSUE. INFORMATION WAS ALSO RECEIVED FROM THE SURGEON THAT THE PATIENT'S PRIOR CONDITION (CARDIOVASCULAR DISEASE) WAS LIKELY A CONTRIBUTORY FACTOR." }, { "mdr_text_key": "312101168", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THREE DAYS AFTER SURGERY, THE NEUROSURGERY FELLOW NOTIFIED A REPRESENTATIVE OF MEDTECH, THE CST, THAT THE PATIENT HAD A HEMORRHAGE AND WAS IN THE INTENSIVE CARE UNIT. THE FELLOW BELIEVED HIGH BLOOD PRESSURE DURING SURGERY MAY HAVE PLAYED A ROLE AND INDICATED THAT BLOOD WAS PRESENT ON LEFT SIDE, WHERE ONLY THREE ELECTRODES WERE PLACED, DESPITE THE HIGHER CONCENTRATION OF ELECTRODES ON THE RIGHT SIDE. ELECTRODES FOR TRAJECTORIES LA AND LPH APPEAR BENT BUT ACCURATE, AND TRAJECTORY LAH APPEARS 2 MILLIMETERS DEEP. INACCURATE ELECTRODE PLACEMENTS ON THE RIGHT SIDE LIKELY DID NOT CONTRIBUTE TO THIS ISSUE. INFORMATION WAS ALSO RECEIVED FROM THE SURGEON THAT THE PATIENT'S PRIOR CONDITION (CARDIOVASCULAR DISEASE) WAS LIKELY A CONTRIBUTORY FACTOR." }, { "mdr_text_key": "312101169", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AN HEMORRHAGE OCCURRED POST-OPERATIVELY. A DHR REVIEW AND A COMPLAINT HISTORY REVIEW WERE PERFORMED AND DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A FULL ANALYSIS OF DATA LOG INDICATES AN INACCURACY OCCURRED AND COULD BE THE CAUSE OF THE HEMORRHAGE. THIS INACCURACY IS DUE TO A USER ERROR WHICH DID NOT FOLLOW THE IFU RECOMMENDATIONS. INDEED, THE SURGEON DECIDED TO PROCEED WITHOUT ATTACHING THE PATIENT TO ROSA DEVICE AS SPECIFIED IN THE IFU. THEN, 2 ADDITIONAL PROBABLE ROOT CAUSES WERE IDENTIFIED : THE ELECTRODES DEFORMATION AND PATIENT'S CARDIOVASCULAR ISSUES. NO ADVERSE EVENT OTHER THAN THE HEMORRHAGE ARE REPORTED REGARDING PATIENT'S HEALTH. THE INVESTIGATION DETERMINED THAT THE ROSA DEVICE DID NOT CONTRIBUTE TO THE ISSUE." } ], "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": "01/22/2019" } ] }