{ "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": "3009185973-2020-00198", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200903", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20200806", "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": "20200903", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "953735", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200903", "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": [ "Incorrect, Inadequate or Imprecise Result or Readings", "Incorrect, Inadequate or Imprecise Result or Readings" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/12/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250724", "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": "20200903", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient", "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20201113", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10489144", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200806", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Notification" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "321142886", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE FOLLOWING EVENT OCCURRED DURING AN SEEG CASE AT (B)(6) HOSPITAL. AFTER FINISHING THE SEEG CASE WHERE THE PATIENT HAD BEEN CONNECTED TO THE ROSA VIA THE MAYFIELD ADAPTOR CLAMPED ONTO THE LEKSELL FRAME, A POST-OP SCAN WAS TAKEN IN THE OPERATING ROOM (WHILE THE PATIENT WAS STILL UNDER ANESTHESIA) UTILIZING AN O-ARM. THE SCAN WAS THEN TRANSFERRED TO THE ROBOT VIA USB AND SUBSEQUENTLY MERGED TO AN MRI SCAN, WHICH WAS USED FOR INITIAL PLANNING. THE SURGEON VERIFIED THE MERGE AND THEN COMPARED THE SCAN TO THE PLAN. THE SURGEON NOTED THAT THE ELECTRODES DEVIATED ANTERIORLY FROM THE PLANNED TRAJECTORIES (THIS DEVIATION WAS NOTICED ON EACH TRAJECTORY ENTRY AND TARGET). THE SURGEON DID NOT EXPRESS NEED FOR A REVISION AND DID NOT ADJUST PLACEMENT OF ANY ELECTRODES. HOWEVER, THE SURGEON COMMENTED THEIR COULD BE A MERGE ISSUE, ALTHOUGH HE DID NOT PERSONALLY RECOGNIZE ONE, WHEN AT THE STEP THAT ASKED TO VERIFY THE 3D MERGE. THE FIELD SERVICE ENGINEER, ONCE THE PATIENT WAS DISCONNECTED LOOKED AT THE MERGE BETWEEN THE PRE-OP O ARM SPIN USED FOR REGISTRATION AND THE POST-OP SCAN TO SEE IF THERE WAS AN ISSUE THAT COULD BE IDENTIFIED WITH THE MERGE. WHEN COMPARING THE FIDUCIALS FROM PRE-OP TO POST-OP THEY TOO SEEM TO HAVE SHIFTED ANTERIORLY SUGGESTING A POSSIBLE MERGE ISSUE WITH THE POST-OP SCAN. IT SHOULD BE NOTED THE PATIENT'S WAS NOT REPORTED TO HAVE MOVED DURING THE CASE AND THAT THE PATIENT DID NOT RECEIVE ADDITIONAL ANESTHETICS DUE TO THIS EVENT. ADDITIONALLY, THE PLAN WAS MADE ON THE PLANNING STATION AND TRANSFERRED TO THE ROBOT VIA USB." }, { "mdr_text_key": "321142887", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ZIMMER BIOMET ROBOTICS HAS BEEN INFORMED OF A COMPLAINT REGARDING 'ELECTRODES THAT HAVE DEVIATED ANTERIORLY FROM THE PLANNED TRAJECTORIES. THE SURGEON COMMENTED THAT THERE COULD BE A MERGER ISSUE' DURING A SEEG CASE. THE SURGEON DID NOT EXPRESS NEED FOR A REVISION AND DID NOT ADJUST PLACEMENT OF ANY ELECTRODES. A DETAILED ANALYSIS OF THE DATA LOGS AND PATIENT FILE HAS BEEN PERFORMED AND REVEALED THAT THE POST-OPERATIVE SCAN WAS NOT MERGED OPTIMALLY WITH THE PRE-OPERATIVE EXAM. THIS ISSUE COULD HAVE BEEN AVOIDED BY PERFORMING MANUAL ADJUSTMENTS AS RECOMMENDED IN THE USER MANUAL. THEREFORE, THE EVENT DESCRIBED IN THE COMPLAINT DESCRIPTION IS NOT CONSIDERED AS AN ISSUE BUT IT CAN BE CONSIDERED AS A USE ERROR." }, { "mdr_text_key": "205683300", "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": "205683301", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING EVENT OCCURRED DURING AN SEEG CASE AT (B)(6) HOSPITAL. AFTER FINISHING THE SEEG CASE WHERE THE PATIENT HAD BEEN CONNECTED TO THE ROSA VIA THE MAYFIELD ADAPTOR CLAMPED ONTO THE LEKSELL FRAME, A POST-OP SCAN WAS TAKEN IN THE OPERATING ROOM (WHILE THE PATIENT WAS STILL UNDER ANESTHESIA) UTILIZING AN O-ARM. THE SCAN WAS THEN TRANSFERRED TO THE ROBOT VIA USB AND SUBSEQUENTLY MERGED TO AN MRI SCAN, WHICH WAS USED FOR INITIAL PLANNING. THE SURGEON VERIFIED THE MERGE AND THEN COMPARED THE SCAN TO THE PLAN. THE SURGEON NOTED THAT THE ELECTRODES DEVIATED ANTERIORLY FROM THE PLANNED TRAJECTORIES (THIS DEVIATION WAS NOTICED ON EACH TRAJECTORY ENTRY AND TARGET). THE SURGEON DID NOT EXPRESS NEED FOR A REVISION AND DID NOT ADJUST PLACEMENT OF ANY ELECTRODES. HOWEVER, THE SURGEON COMMENTED THEIR COULD BE A MERGE ISSUE, ALTHOUGH HE DID NOT PERSONALLY RECOGNIZE ONE, WHEN AT THE STEP THAT ASKED TO VERIFY THE 3D MERGE. THE FIELD SERVICE ENGINEER, ONCE THE PATIENT WAS DISCONNECTED LOOKED AT THE MERGE BETWEEN THE PRE-OP O ARM SPIN USED FOR REGISTRATION AND THE POST-OP SCAN TO SEE IF THERE WAS AN ISSUE THAT COULD BE IDENTIFIED WITH THE MERGE. WHEN COMPARING THE FIDUCIALS FROM PRE-OP TO POST-OP THEY TOO SEEM TO HAVE SHIFTED ANTERIORLY SUGGESTING A POSSIBLE MERGE ISSUE WITH THE POST-OP SCAN. IT SHOULD BE NOTED THE PATIENT'S WAS NOT REPORTED TO HAVE MOVED DURING THE CASE AND THAT THE PATIENT DID NOT RECEIVE ADDITIONAL ANESTHETICS DUE TO THIS EVENT. ADDITIONALLY, THE PLAN WAS MADE ON THE PLANNING STATION AND TRANSFERRED TO THE ROBOT VIA USB." } ], "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": "11/13/2020" } ] }