{ "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": "MS.", "manufacturer_contact_state": "IN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "MAUGUIO, LANGUEDOC-ROUSSILLON", "manufacturer_contact_address_1": "56 E. BELL DRIVE", "manufacturer_contact_pcity": "57452603", "event_type": "Injury", "report_number": "3009185973-2025-00007", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250604", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20250506", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "46582", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "5745260384", "noe_summarized": "1", "manufacturer_contact_l_name": "RAPSAVAGE", "source_type": [ "Foreign", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "GM", "manufacturer_contact_area_code": "574", "date_added": "20250604", "manufacturer_contact_f_name": "JENNIFER", "device_date_of_manufacturer": "20210701", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1019534", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20250604", "brand_name": "ROSA ONE SYSTEM - DE PLUG F", "generic_name": "MULTI-PURPOSE STEREOTACTIC SURGERY SYSTEM", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "ROSAS00209", "lot_number": "N/A", "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": "03760244034298", "udi_public": "(01)03760244034298", "openfda": { "device_name": "Neurological Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Disconnection", "Disconnection" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/18/2025", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260218", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "5745", "patient": [ { "patient_sequence_number": "1", "date_received": "20250604", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "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": "20251218", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "WARSAW", "mdr_report_key": "22141607", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250506", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "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": "371660566", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(B)(4) G2: FOREIGN: GERMANY. THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED AND THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED." }, { "mdr_text_key": "371660567", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING SURGERY, THE ROBOT DISCONNECTED THE ARM AFTER REGISTRATION AND VERIFICATION. SOFTWARE AND THE ROBOT WERE RESTARTED, AND THE ROSA WAS POWERED OFF FOR 3 MINUTES. THE ROSA STILL DIDN´T RECONNECT THE ARM. SURGERY WAS CANCELED WHILE PATIENT WAS UNDER GENERAL ANESTHESIA AND HAD IMPLANTED BONE FIDUCIALS JUST FOR THE CASE. AFTER SERVICE, THE SURGERY WENT WELL AND WITHOUT ISSUES. IT WAS AN EPILEPSY PATIENT, WHERE 8 ELECTRODES WERE INSERTED DURING SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME." }, { "mdr_text_key": "393301461", "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": "393301462", "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: D4; H1; H2; H3; H4; H6; H11. THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF DATA LOGS. A FULL ANALYSIS OF THE DATA LOGS WAS PERFORMED BY THE JIRA ENGINEERING SERVICE SUPPORT TEAM. THE LOGS CONFIRMED COMMUNICATION WAS LOST WITH THE CONTROLLER AND ERRORS INDICATE AN ISSUE WITH THE STARC CARD. A CORRECTIVE MAINTENANCE WAS PERFORMED BY A FIELD SERVICE ENGINEER (FSE) FOR THIS ISSUE. PER JIRA RECOMMENDATION, THE FSE RE-SLOTTED THE STARC CARD AND TIGHTENED THE FT (FORCE TORQUE) SENSOR CABLE. THE FSE CONFIRMED THE ARM WAS CONNECTED AND PERFORMED SYSTEM TEST, WHICH PASSED. THE SYSTEM WAS FUNCTIONAL AS PER SPECIFICATION AND RELEASED FOR USE. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. PER ADDITIONAL INFORMATION, THE SURGERY WAS CANCELED AFTER THE BONE FIDUCIALS WERE ALREADY IMPLANTED. A FOLLOW-UP SURGERY WAS PERFORMED AFTER THE ROBOT REPAIR, WHICH CONFIRMED THE PATIENT¿S CONDITION WAS FINE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "432 RUE DU RAJOL", "distributor_zip_code": "", "manufacturer_contact_postal_code": "46582", "manufacturer_contact_exchange": "574", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "12/31/2025" } ] }