{ "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": "", "report_to_fda": "N", "manufacturer_contact_t_name": "MR.", "manufacturer_contact_state": "FL", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "MAUGUIO, LANGUEDOC-ROUSSILLON", "manufacturer_contact_address_1": "1520 TRADEPORT DRIVE", "manufacturer_contact_pcity": "90474144", "event_type": "Injury", "report_number": "3009185973-2021-00184", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20211207", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20211110", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "32218", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "9047414400", "noe_summarized": "1", "manufacturer_contact_l_name": "SHARMA", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "34130", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "904", "date_added": "20211207", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20201127", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1845344", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20211207", "brand_name": "ROSA ONE BRAIN + SPINE", "generic_name": "COMPUTER-ASSISTED SURGICAL DEVICE", "manufacturer_d_name": "MEDTECH SA", "manufacturer_d_address_1": "432 RUE DU RAJOL", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAUGUIO, LANGUEDOC-ROUSSILLON", "manufacturer_d_state": "", "manufacturer_d_zip_code": "34130", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "FR", "manufacturer_d_postal_code": "34130", "device_operator": "HEALTH PROFESSIONAL", "model_number": "ROSA ONE", "catalog_number": "ROSAS00203", "lot_number": "3.1.5.28", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "HAW", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "03760244033765", "udi_public": "(01)03760244033765", "openfda": { "device_name": "Neurological Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Positioning Failure", "Unintended Collision", "Incorrect, Inadequate or Imprecise Result or Readings", "Positioning Failure", "Unintended Collision", "Incorrect, Inadequate or Imprecise Result or Readings" ], "reporter_state_code": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/10/2021;02/27/2024;04/12/2022", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250728", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9047", "patient": [ { "patient_sequence_number": "1", "date_received": "20211207", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other", " H" ], "patient_age": "30 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hematoma", "Intracranial Hemorrhage", "Paralysis", "Hematoma", "Intracranial Hemorrhage", "Paralysis" ] } ], "distributor_city": "", "date_report": "20240419", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "FR", "manufacturer_contact_city": "JACKSONVILLE", "mdr_report_key": "12948229", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20211111", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "34130", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MEDTECH SA", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "327317745", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A DETAILED ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED, AND REVEALED THAT THE FUSION OF THE POST-OPERATIVE CT TO THE PRE-OPERATIVE CT HAD NOT BEEN PERFORMED PROPERLY BY THE USER. HOWEVER, PROPER FUSION RESULTS COULD NOT BE ACHIEVED USING A ROSA SIMULATOR DURING OUR INVESTIGATIONS; CONSEQUENTLY, THE ACTUAL PLACEMENT OF THE ELECTRODES COULD NOT BE REVIEWED AND THE INACCURACY CANNOT BE CONFIRMED. HOWEVER, OUR REVIEW OF AVAILABLE FILES DID NOT SUGGEST ANY ISSUE WITH THE REGISTRATION PROCESS, THE PRE-OPERATIVE FUSION OR THE ROSA LOG FILES. NO FAILURE OF THE DEVICE OR USER ERROR IS SUSPECTED. THE REPORTED INACCURACY REMAINS UNCONFIRMED." }, { "mdr_text_key": "327317746", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT IT WAS COMPLETED A 13 TRAJECTORY BILATERAL SEEG CASE USING THE ROSA ROBOT WITH A COMPANY REPRESENTATIVE PRESENT. THE PATIENT WAS PUT TO SLEEP, PINNED IN A MAYFIELD HEAD CLAMP, ATTACHED TO ROSA AND REGISTERED USING CONTACTLESS REGISTRATION. ALL 13 TRAJECTORIES WERE PLACED AS NORMAL. THE COMPANY REPRESENTATIVE THEN RECEIVED AN EMAIL THE NEXT DAY FROM THE SURGEON STATING THAT THE PATIENT HAD A BRAIN HEMORRHAGE THAT WAS SEEN ON A POST OPERATIVE CT SCAN. THE INFORMATION THAT WAS GIVEN WAS THAT THE MAJORITY OF THE ELECTRODES WERE PLACED CORRECTLY, BUT A COUPLE WERE OFF TARGET." }, { "mdr_text_key": "281846055", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "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": "281846056", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT IT WAS COMPLETED A 13 TRAJECTORY BILATERAL SEEG CASE USING THE ROSA ROBOT WITH A COMPANY REPRESENTATIVE PRESENT. THE PATIENT WAS PUT TO SLEEP, PINNED IN A MAYFIELD HEAD CLAMP, ATTACHED TO ROSA AND REGISTERED USING CONTACTLESS REGISTRATION. ALL 13 TRAJECTORIES WERE PLACED AS NORMAL. THE COMPANY REPRESENTATIVE THEN RECEIVED AN EMAIL THE NEXT DAY FROM THE SURGEON STATING THAT THE PATIENT HAD A BRAIN HEMORRHAGE THAT WAS SEEN ON A POST OPERATIVE CT SCAN. THE INFORMATION THAT WAS GIVEN WAS THAT THE MAJORITY OF THE ELECTRODES WERE PLACED CORRECTLY, BUT A COUPLE WERE OFF TARGET." }, { "mdr_text_key": "339354377", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ADDITIONAL INFORMATION RECEIVED FROM LEGAL DOCUMENTATION AND COMPLAINT INFORMATION HAS BEEN UPDATED. THE ADDITIONAL INFORMATION HAS NOT YET BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE ADDITIONAL EVALUATION IS PERFORMED AND THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED." }, { "mdr_text_key": "339354378", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED WITH THE USE OF ROSA ONE BRAIN, SEEG PROCEDURE WAS PLANNED AND COMPLETED WITH A TOTAL OF 14 ELECTRODE PLACEMENTS. THERE WAS A 'ROBOT COLLISION' AND THE ORBITOFRONTAL ('X2 AND TEMPORAL POLE ELECTRODE WERE NOT PLACED'). IT IS UNKNOWN AT WHAT TIME DURING THE PROCEDURE THE 'ROBOT COLLISION' OCCURRED. IMMEDIATELY POST OPERATIVE PERIOD IT WAS REPORTED THE PATIENT EXPERIENCED BEHAVIOR CHANGES, HEMIPARESIS, AND CT SCAN WAS PERFORMED INDICATING HEMORRHAGE. APPROXIMATELY TWO DAYS AFTER SURGERY, IT WAS NOTED EMERGENT INTUBATION WITH PROGRESSIVE LEFTWARD SHIFT OF HEMORRHAGE WAS NOTED AND TAKEN TO SURGERY. SEEG ELECTRODES REMOVED. WHILE REMOVING ONE OF THE ELECTRODES IT WAS NOTED THERE WAS CLOT/HEMATOMA ACTIVITY FOUND. LEGAL REPORTS ONGOING DISABILITIES." }, { "mdr_text_key": "341061120", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. UPDATED: H2; H3; H6. ACCORDING TO ADDITIONAL INFORMATION FROM LEGAL, THERE WAS A ¿ROBOT COLLISION¿ DURING THE SURGICAL PROCEDURE. THE ASSOCIATED INVESTIGATION LOG FILES WERE ANALYZED BY A SUBJECT MATTER EXPERT. REVIEW OF THE EVENT LOG FILES CONFIRM THAT A COLLISION WAS DETECTED IN THE FORCE SENSOR AND THE SYSTEM GAVE THE USER TWO COLLISION WARNINGS BACK-TO-BACK. THE USER WAS ULTIMATELY ABLE TO CONTINUE THE ARM MOVEMENT AND COMPLETED THE CASE WITH NO FURTHER COLLISION MESSAGES. THE CONTROLLER LOGS WERE REVIEWED, BUT NO OBVIOUS ERRORS WERE SEEN. THERE WERE NO SOFTWARE ANOMALIES IDENTIFIED WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. NO OTHER CHANGES WERE MADE TO THE ORIGINAL INVESTIGATION CONCLUSIONS. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS." }, { "mdr_text_key": "341061181", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "432 RUE DU RAJOL", "distributor_zip_code": "", "manufacturer_contact_postal_code": "32218", "manufacturer_contact_exchange": "904", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "12/16/2021;03/25/2024;04/24/2024" } ] }