{ "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": "3009185973-2020-00175", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200729", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20200706", "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": "GM", "manufacturer_contact_area_code": "", "date_added": "20200729", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "803235", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200729", "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": "ROSAS00209", "lot_number": "3.1.3.1494", "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": [ "Mechanics Altered", "Mechanics Altered" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/28/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250730", "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": "20200729", "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": "20210129", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10338052", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200706", "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": "202017902", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "202017903", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE SURGEON CALLED A FIELD SERVICE ENGINEER (FSE) AND TOLD, THAT THE ROBOT IS STUCK IN A SINGULAR POSITION FREE IN SPACE. ROSA LETTER BOTTOM UP. ROSANNA ASKED TO RESTART, THE SURGEON DID SO. AFTER THE RESTART THE SYSTEM STARTED THE CLEARANCE PROCEDURE, BUT BEFORE THEY COULD MOVE THE ARM THE SYSTEM SHUT DOWN AGAIN. THE FSE ASKED THEM TO SHUT DOWN AND WAIT POWERED OFF MINIMUM 1 MINUTE, BUT THIS ALSO DIDN´T HELP. THEY TRIED SEVERAL TIMES. FINALLY THEY USED KINEVERIF TO MOVE THE ARM TO HOME POSITION AND WERE ABLE TO PROCEED WITH SURGERY. AFTER 4 SEEG-ELECTRODES THE SURGEON MOVED THE ARM DOWN USING THE AXIAL COOPERATIVE MODE. THE ARM TOUCHED SLIGHTLY THE MAYFIELD WITH AXIS 5. THE SURGEON WANTED TO PUSH THE ARM BACK, BUT IT GOT STUCK AGAIN. SYSTEM SHUT DOWN. CLEARANCE PROCEDURE NOT WORKING AFTER RESTART. THEY REMOVED THE PATIENT FROM THE ROBOT, BUT EVEN THEN THE ROBOT DID NOT MOVE. THEY AGAIN USED KINEVERIF TO MOVE THE ROBOT TO HOME POSITION. AFTER NEW INSTALLATION OF THE PATIENT AND REREGISTERING, THEY FINISHED THE SURGERY." }, { "mdr_text_key": "322044744", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE SURGEON CALLED A FIELD SERVICE ENGINEER (FSE) AND TOLD, THAT THE ROBOT IS STUCK IN A SINGULAR POSITION FREE IN SPACE. (B)(6) LETTER BOTTOM UP. (B)(6) ASKED TO RESTART, THE SURGEON DID SO. AFTER THE RESTART THE SYSTEM STARTED THE CLEARANCE PROCEDURE, BUT BEFORE THEY COULD MOVE THE ARM THE SYSTEM SHUT DOWN AGAIN. THE FSE ASKED THEM TO SHUT DOWN AND WAIT POWERED OFF MINIUM 1 MINUTE, BUT THIS ALSO DIDN´T HELP. THEY TRIED SEVERAL TIMES. FINALLY THEY USED KINEVERIF TO MOVE THE ARM TO HOME POSITION AND WERE ABLE TO PROCEED WITH SURGERY. AFTER 4 SEEG-ELECTRODES THE SURGEON MOVED THE ARM DOWN USING THE AXIAL COOPERATIVE MODE. THE ARM TOUCHED SLIGHTLY THE MAYFIELD WITH AXIS 5. THE SURGEON WANTED TO PUSH THE ARM BACK, BUT IT GOT STUCK AGAIN. SYSTEM SHUT DOWN. CLEARANCE PROCEDURE NOT WORKING AFTER RESTART. THEY REMOVED THE PATIENT FROM THE ROBOT, BUT EVEN THEN THE ROBOT DID NOT MOVE. THEY AGAIN USED KINEVERIF TO MOVE THE ROBOT TO HOME POSITION. AFTER NEW INSTALLATION OF THE PATIENT AND REREGISTERING, THEY FINISHED THE SURGERY." }, { "mdr_text_key": "322044745", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND THIS ANALYSIS CONCLUDED THAT THREE MAJOR EVENTS OCCURRED DURING THIS CASE: THE FIRST COMMUNICATION ERROR WHICH OCCURRED DURING REGISTRATION AND PROVOKED THE DEVICE SHUTDOWN WAS DUE TO THE DETECTION OF ONE ARM AXIS OUT OF ITS LIMITS. AS THE ARM WAS LOCKED IN A SINGULAR POSITION, THE REGULAR PROCEDURE TO RESTART THE ARM FAILED AND THE ARM COULD ONLY BE MOVED USING KINEVERIF. KINEVERIF IS A SOFTWARE USED IN MAINTENANCE AND RESERVED TO ZIMMER BIOMET TEAM MEMBERS IN ORDER TO PERFORM THE ACCURACY VERIFICATION OF THE ROBOT. IT NOTABLY PERMITS TO SEND THE ARM ON PREDEFINED POSITIONS PARKING AND HOME. IN THIS CASE, IT WAS USED UNDER THE SUPERVISION OF A FIELD SERVICE ENGINEER (FSE) AND WAS NECESSARY TO SOLVE THE SITUATION. THIS ISSUE WHICH COULD NOT BE REPRODUCED ON MANUFACTURING SITE. THE SECOND COMMUNICATION ERROR OCCURRED IN GUIDANCE IN AXIAL COOPERATIVE MOVEMENT, AS DESCRIBED IN COMPLAINT AND WAS PROBABLY DUE TO THE COLLISION WITH THE MAYFIELD HEAD HOLDER. HOWEVER, THE CORRECT SEQUENCE OF EVENTS COULD NOT BE FOUND IN THE CONTROLLER LOGS. THE ARM WAS DIRECTLY CLEARED ON THE PREDEFINED HOME POSITION FROM KINEVERIF WHEREAS THE FINAL POSITION WAS ELIGIBLE TO A REGULAR CLEARANCE PROCEDURE. THE FIRST ATTEMPT FAILED DUE TO A COMMUNICATION ERROR BETWEEN THE SOFTWARE AND THE CONTROLLER WHOSE CAUSE REMAINS UNKNOWN. IT IS PROBABLE THAT THE CONTROLLER REQUIRED TO BE REINITIALIZED. A THIRD COMMUNICATION ERROR WHICH WAS NOT REPORTED OCCURRED DURING AN AUTOMATIC MOVEMENT IN GUIDANCE AND WAS DUE TO THE DETECTION OF AN INCORRECT TOOL FINAL POSITION. THE SOFTWARE ANOMALY IS KNOWN. MULTIPLE ATTEMPTS OF RECONNECTION - STILL THOUGH KINEVERIF - WERE ATTEMPTED BEFORE TO BE SUCCESSFUL. ONCE AGAIN, THE FINAL POSITION WAS ELIGIBLE TO A REGULAR CLEARANCE PROCEDURE. THE SAME COMMUNICATION ERROR BETWEEN THE SOFTWARE AND THE CONTROLLER WAS DETECTED. HOWEVER, THERE IS NOT ENOUGH ELEMENTS TO CONCLUDE ABOUT THE CAUSE FOR THIS ISSUE. THE FINAL ATTEMPT PERMITTED TO SEND THE ARM ON THE PREDEFINED PARKING POSITION. FOLLOWING THIS FINAL ERROR, A NEW REGISTRATION WAS PERFORMED AND THE CASE RESUMED. THE PROBLEM IS CONSIDERED AS AN ISOLATED EVENT AND ALTHOUGH SOFTWARE ANOMALIES OCCURRED, THE DEVICE BEHAVED AS EXPECTED : ERRORS WERE DETECTED AND THE DEVICE PROCEEDED TO SECURITY SHUTDOWN. THE EVENT DESCRIBED IN THE COMPLAINT IS CONFIRMED. CORRECTED DATA: B4: DATE OF THIS REPORT. G4: DATE RECEIVED BY MANUFACTURER. H2: IF FOLLOW-UP, WHAT TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H6: EVENT PROBLEM AND EVALUATION CODES." } ], "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": "01/29/2021" } ] }