{ "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": "3009185973-2020-00026", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200205", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20200110", "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": "20200205", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "134854", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200205", "brand_name": "ROSA ONE", "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 ONE", "catalog_number": "ROSAS00203", "lot_number": "3.1.1.1295", "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": [ "Display or Visual Feedback Problem", "Display or Visual Feedback Problem" ], "reporter_state_code": "MA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/31/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250808", "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": "20200205", "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": "20200731", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9670523", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200110", "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": "319584607", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A DETAILED ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED. THIS ANALYSIS CONFIRMED THAT THE POINTING TOOL WAS POINTING TO THE BACK OF THE PATIENT'S HEAD ON THE SCREEN WHILE IN REALITY THE USER WAS POINTING TO THE FRONT. THE INVESTIGATION REVEALED THAT THIS EVENT WAS DUE TO AN INSUFFICIENT NUMBER OF MARKERS AND TO THEIR INCORRECT REPARTITION. AS INDICATED IN THE INSTRUCTION FOR USE, WHEN PERFORMING FIDUCIAL REGISTRATION, IT IS STRONGLY RECOMMENDED TO USE AT LEAST 5 FIDUCIALS. THE MARKERS MUST BE DISTRIBUTED OVER THE PATIENT'S HEAD NON-SYMMETRICALLY AND NOT IN THE SAME PLANE. IT WAS ALSO NOTED THAT THE LEKSELL HEAD HOLDER SCREWS WERE USED AS MARKERS INSTEAD OF THE RECOMMENDED MARKERS. THIS DEVICE USAGE HAS NOT BEEN VALIDATED BY ZIMMER BIOMET ROBOTICS AND DOES NOT ALLOW TO FULFILL THE RECOMMENDATIONS CITED ABOVE. ADDITIONALLY, THE INVESTIGATION REVEALED THAT ONLY 4 POINTS AMONG THE 7 REQUIRED WERE VERIFIED. IN SUCH CASE, THE REGISTRATION ACCURACY CANNOT BE GUARANTEED. IN THE COURSE OF THE INVESTIGATION, IT WAS NOTED THAT THERE WAS AN OCCURRENCE OF A KNOWN SOFTWARE ANOMALY." }, { "mdr_text_key": "319584608", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "MARKERS REGISTRATION FLIPPED ANTERIOR AND POSTERIOR UPON VERIFICATION. MARKERS WERE RECORDED IN CORRECT ORDER. REGISTRATION WAS PERFORMED AGAIN, AND AN ADDITIONAL MARKER WAS DEFINED ON THE LEKSELL FRAME TO ORIENT AN ADDITIONAL MARKER IN NON-SYMMETRICAL PLACEMENT. RMS WAS ACCEPTABLE. DELAY OF 25 MINUTES. PATIENT UNDER ANESTHESIA, BUT AWAKE, DBS PROCEDURE, PATIENT PINNED. NO INCISION." }, { "mdr_text_key": "177806622", "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. UNIQUE IDENTIFIER (UDI) #:(B)(4)." }, { "mdr_text_key": "177806623", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "MARKERS REGISTRATION FLIPPED ANTERIOR AND POSTERIOR UPON VERIFICATION. MARKERS WERE RECORDED IN CORRECT ORDER. REGISTRATION WAS PERFORMED AGAIN, AND AN ADDITIONAL MARKER WAS DEFINED ON THE LEKSELL FRAME TO ORIENT AN ADDITIONAL MARKER IN NON-SYMMETRICAL PLACEMENT. RMS WAS ACCEPTABLE. DELAY OF 25 MINUTES. PATIENT UNDER ANESTHESIA, BUT AWAKE, DBS PROCEDURE, PATIENT PINNED. NO INCISION." } ], "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": "08/03/2020" } ] }