{ "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": "3009185973-2023-00004", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20230228", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20230201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "32218", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9047414400", "noe_summarized": "1", "manufacturer_contact_l_name": "SHARMA", "source_type": [ "Foreign", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "34130", "manufacturer_g1_state": "", "reporter_country_code": "FR", "manufacturer_contact_area_code": "904", "date_added": "20230228", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20180523", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "561013", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20230228", "brand_name": "ROSA ONE SYSTEM - EU PLUG E", "generic_name": "COMPUTER-ASSISTED SURGICAL DEVICE", "manufacturer_d_name": "MEDTECH SAS", "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": "N/A", "catalog_number": "ROSAS00201", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "HAW", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "03760244030085", "udi_public": "(01)03760244030085(11)180523", "openfda": { "device_name": "Neurological Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Computer Software Problem", "Output Problem", "Computer Software Problem", "Output Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/20/2023", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250725", "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": "20230228", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20230428", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "FR", "manufacturer_contact_city": "JACKSONVILLE", "mdr_report_key": "16453409", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230201", "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 SAS", "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": "310353549", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED DURING THE PROCEDURE, ROSA ROBOT HAD THE MESSAGE \"COLLISION DETECTED\" WITHOUT SHOCK. ATTEMPTS WERE MADE BUT IMPOSSIBLE TO RECONNECT. THE INTERVENTION OF THE PATIENT WAS FINALLY CANCELLED FOR A REASON PARALLEL TO THE DYSFUNCTION OF ROSA AND THE REPRODUCTION OF THE PROBLEM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME." }, { "mdr_text_key": "310353550", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(B)(4). ROBOT REMAINS AT HOSPITAL AND IS ANTICIPATED TO BE EVALUATED. AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED." }, { "mdr_text_key": "334870639", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT." }, { "mdr_text_key": "334870640", "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: D4; H2; H3; H6 A FIELD SERVICE ENGINEER (FSE) CHECKED THE FUNCTIONALITY OF THE SUBJECT ROSA SYSTEM AND OBSERVED THAT THE FORCE SENSOR CABLE WAS DAMAGED AND NEEDED TO BE REPLACED. THE FSE PROCEEDED TO REPLACE THE CABLE AND THE ROSA UNIT WAS CONFIRMED TO BE WORKING PROPERLY AT THAT TIME. HOWEVER, THE FSE WAS NOTIFIED THAT THE ARM CONNECTION ISSUE PERSISTED, SO A SECOND SERVICING INTERVENTION WAS SCHEDULED A FEW DAYS LATER. DURING THIS SERVICING INTERVENTION, THE FSE CONFIRMED THE CONNECTION WITH THE ROBOTIC ARM WAS PERIODICALLY WORKING. TO FURTHER ADDRESS THE ISSUE, THE FSE CHANGED THE STAUBLI STARC BOARD SLOT. AFTER MAKING THIS CHANGE, ALL UNIT CHECKS, TESTS, AND CALIBRATIONS PASSED. THE ROSA UNIT WAS WORKING PER SPECIFICATION AND NO FURTHER ACTION WAS REQUIRED. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. THE REPORTED EVENT WAS DUE TO A DAMAGED FT SENSOR CABLE AND LOOSENED STARC BOARD. HOWEVER, THE CAUSES FOR THE DAMAGED CABLE AND LOOSENED BOARD CANNOT BE DETERMINED WITH THE INFORMATION AVAILABLE. 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." } ], "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": "05/02/2023" } ] }