{ "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": "3009185973-2019-00165", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190510", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190412", "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": "20190510", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "395045", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190510", "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 3.0", "catalog_number": "ROSAS00303", "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": "04/03/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20190510", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient", "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20200414", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8598444", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190412", "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": "317469592", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REPORTEDLY, ONE ELECTRODE WAS NOT POSITIONED ACCURATELY AT ENTRY ALTHOUGH THE ANCHOR BOLT WAS ACCURATELY PLACED. THE SURGEON PLANNED ALTERNATIVE TRAJECTORY BUT THE NEW ELECTRODE WAS APPROXIMATELY 14 MM ABOVE PLANNED TARGET. THE SURGEON BELIEVED UNKNOWN CEREBRAL ELEMENT DEFLECTING ELECTRODES. EVENT SUMMARY, DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. ANOTHER COMPLAINT FOR AN IMPRECISION WAS RECEIVED PREVIOUSLY FOR THIS DEVICE, HOWEVER FOR THIS ONE THE INACCURACY COULD BE CONFIRMED. FOR THE SUBJECT COMPLAINT, THE INVESTIGATION CONFIRMED THAT ALL THE 20 ELECTRODES PLANNED WERE INSERTED WITH ACCURACY AT THE ENTRY POINT. HOWEVER, TRAJECTORY JJ WAS MEASURED AROUND 14 MM AWAY FROM THE TARGET POINT BECAUSE THE ELECTRODE WAS CURVED INSIDE THE BRAIN. THE TRAJECTORY INSIDE THE BRAIN IS NOT RELATED TO THE PERFORMANCE OF THE ROBOT, BUT DEPENDS ON SEVERAL FACTORS SUCH AS THE METHOD OF IMPLANTATION, THE CHARACTERISTICS OF THE ELECTRODE (E.G. STIFFNESS) AND THE PATIENT ANATOMY. A USE ERROR WAS NOTED - REGISTRATION VERIFICATION STEP SKIPPED - BUT IT DID NOT HAVE ANY IMPACT ON THE ROBOT ARM POSITIONING ACCURACY. NO FAILURE OR MALFUNCTION OR NON-CONFORMANCE WAS DETECTED FOR THE DEVICE BR17036. CORRECTED DATA: B1: REPORT TYPE. B4: DATE OF THIS REPORT. D4: CATALOG NUMBER. G4: DATE RECEIVED BY MANUFACTURER. H1: TYPE OF REPORTABLE EVENT. H2: IF FOLLOW-UP, WHAT TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H6: EVENT PROBLEM AND EVALUATION CODES. H10: ADDITIONAL NARRATIVES/DATA." }, { "mdr_text_key": "317469593", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AT APPROXIMATELY 12:30PM, POST OPERATIVE CT SCAN NAMED CT POSTOP WAS ACQUIRED BY O-ARM AND LOADED INTO ROSA. SURGEON NOTED 19 ACCURATE ELECTRODES AND 1 INACCURATE ELECTRODE AT TRAJECTORY J ALTHOUGH ANCHOR BOLT WAS ACCURATELY PLACED. ELECTRODE WAS APPROXIMATELY 7MM ABOVE PLANNED TARGET. SURGEON PLANNED ALTERNATIVE TRAJECTORY JJ BUT POSTOPERATIVE CT SCAN NAMED CT POSTOP2 SHOWED NEW ELECTRODE WAS APPROXIMATELY 14MM ABOVE PLANNED TARGET. SURGEON BELIEVES UNKNOWN CEREBRAL ELEMENT DEFLECTING ELECTRODES AND THAT INACCURACY IS NOT DUE TO ROSA ERROR, LEFT ELECTRODE JJ IN THE BRAIN FOR RECORDING PURPOSES AND DID NOT INSERT AN ALTERNATIVE." }, { "mdr_text_key": "144709807", "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": "144709808", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AT APPROXIMATELY 12:30PM POST OPERATIVE CT SCAN NAMED CT POSTOP WAS ACQUIRED BY O-ARM AND LOADED INTO ROSA. SURGEON NOTED 19 ACCURATE ELECTRODES AND 1 INACCURATE ELECTRODE AT TRAJECTORY J ALTHOUGH ANCHOR BOLT WAS ACCURATELY PLACED. ELECTRODE WAS APPROXIMATELY 7MM ABOVE PLANNED TARGET. SURGEON PLANNED ALTERNATIVE TRAJECTORY JJ BUT POSTOPERATIVE CT SCAN NAMED CT POSTOP2 SHOWED NEW ELECTRODE WAS APPROXIMATELY 14MM ABOVE PLANNED TARGET. SURGEON BELIEVES UNKNOWN CEREBRAL ELEMENT DEFLECTING ELECTRODES AND THAT INACCURACY IS NOT DUE TO ROSA ERROR, LEFT ELECTRODE JJ IN THE BRAIN FOR RECORDING PURPOSES AND DID NOT INSERT AN ALTERNATIVE." } ], "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": "04/20/2020" } ] }