{ "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": "3009185973-2019-00067", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20190306", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190207", "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": "20190306", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "190001", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190306", "brand_name": "ROSA BRAIN", "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 BRAIN", "catalog_number": "N/A", "lot_number": "3.0.0.21", "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": [ "Imprecision", "Imprecision" ], "reporter_state_code": "KY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/24/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250725", "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": "20190306", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Laceration(s)", "No Code Available", "Laceration(s)", "No Code Available" ] } ], "distributor_city": "", "date_report": "20200127", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8394316", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190207", "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": "315470608", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D4 UNIQUE IDENTIFIER (UDI) #:(B)(4). SECTION H6, PATIENT CODE '3191 - NO CODE AVAILABLE' WAS SELECTED AS THERE WAS A DELAY GREATER THAN 30 MINUTES ON THE SURGERY DUE TO THIS EVENT. THE SURGERY WAS ABORTED. ALSO, WHEN UNDRAPING THE PATIENT, IT WAS FOUND THAT THE PATIENT HAD SUPERFICIAL LACERATIONS TO THE HEAD. IT WAS REPORTED THAT DURING THE SURGERY THE FINAL CT WAS PERFORMED AND IT WAS FOUND THAT THE IMPLANT WAS NOT ACCURATELY POSITIONNED. AT THIS TIME, THE SURGEON DECIDED TO ABORT THE CASE. AS REPORTED THE PATIENT WOKE UP DOING ALRIGHT, WITH NO SIGNS OF ANY BRAIN DAMAGE DUE TO THE SURGERY. EVENT SUMMARY, DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. THE INACCURACIES OBSERVED IN THE DIFFERENT CTS TAKEN ALONG THE SURGERY WAS CONFIRMED BY THE ANALYSIS. MULTIPLE CAUSES CAN BE ATTRIBUTED TO THIS INCORRECT PLACEMENT: THE HEAD HOLDER WAS NOT SECURELY FIXED AND PERMITTED THE HEAD TO MOVE DURING THE SURGERY. THE USER USED A DEVICE (MONTERIS AXIIIS) WHICH IS NOT PART OF THE PRODUCTS OR COMPONENTS THAT ARE EXPRESSLY RECOGNIZED AS COMPATIBLE WITH ROSA BRAIN. THE USE OF SUCH DEVICE WITH THE ROSA ROBOT IS NOT RECOMMENDED, AND ZIMMER BIOMET CANNOT GUARANTEE THAT SUCH CONFIGURATION WILL PROVIDE ADEQUATE PERFORMANCE FOR THE SURGERY IN TERMS OF ACCURACY. THE REGISTRATION WAS ACCEPTED WITH AN INSUFFICIENT ACCURACY, DESPITE THE ERROR MESSAGE AND THE VISIBLE DISCREPANCY OF POSITIONING DURING THE SECOND VERIFICATION. IN SUCH CASE, THE USER SHOULD REPEAT THE REGISTRATION UNTIL SATISFACTORY RESULTS ARE OBTAINED. AS THE DEVICE PASSED MAINTENANCE TESTS BEFORE THE EVENT, AND SINCE THE BRAIN APPLICATIVE TEST WITH THE CONTACTLESS REGISTRATION WAS REPEATED AFTER THE EVENT AND PASSED, IT IS LIKELY THAT THE DEVICE WORKED AS EXPECTED ON THE DAY OF SURGERY." }, { "mdr_text_key": "315470609", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "PATIENT WAS BROUGHT IN ROOM AND HEAD WAS FIXATED ONTO THE BED AS WELL AS BEING ATTACHED TO THE ROSA BRAIN. ONCE THE ROBOT WAS ATTACHED, IT WAS NOTICED THAT THE MONTERIS HEAD FIXATION WAS GOING TO BE IMPEDING WITH THE TRAJECTORY, THEREFORE THE SURGEON AND THE OR STAFF DECIDED TO UTILIZE THE DORO THREEPIN HEAD FIXATION DEVICE. THE SINGLE PIN WAS PLACED ON THE LEFT FOREHEAD NEAR THE HAIRLINE AND THE TWO-PIN SIDE WAS POSITIONED ON THE BACK RIGHT OF THE HEAD. THE PATIENTS WAS SUPINE WITH ABOUT A 60 DEGREE HEAD TILT TO THE LEFT. THE PATIENT THEN WAS CONNECTED DIRECTLY TO ROSA BRAIN. THE LASER REGISTRATION WAS PERFORMED. AFTER COMPLETING REGISTRATION, IT WAS THAT THE ROSA BRAIN STABILIZATION SYSTEM WAW NOT LOCKED DOWN. THE SURGEON WAS INFORMED AND INSTEAD OF RE-DOING REGISTRATION, HE DECIDED TO PERFORM THE VERIFICATION ONCE MORE WITH THE STABILIZATION SYSTEM LOCKED. RE-VERIFICATION SUCCESSFULLY PASSED. A CT SCAN WAS PERFORMED AND WAS MERGED TO ROSA. PATIENT WAS DRAPED AND THE PROCEDURE WAS READY TO BEGIN. THE PATIENT PREVIOUSLY HAD A CRANIOTOMY IN THIS AREA AND HAD A MESH PLATE IMPLANTED. THEREFORE, THE SURGEON COULD NOT PLACE A BOLT IN THIS AREA DUE TO THERE BEING NO BONE. THE SURGEON INSTEAD CUT AN AREA OF THE MESH PLATE AWAY AND USED A AXIIS DEVICE, WHICH IS A 3 LEGGED STABILIZATION DEVICE WITH LAG SCREWS TO FIXATE TO THE SKULL FOR ACCURATE PLACEMENT OF THE ABLATION PROBE. THE SURGEON ATTEMPTED TO PLACE THE AXIIS DEVICE BUT WASN¿T GETTING GOOD PURCHASE OF THE LAG SCREWS IN THE BONE. THE SURGEON ATTEMPTED TO PLACE THE AXIS WITH ROSA BRAIN GUIDANCE AND A MANDREL WAS PLACED IN THE AXIIS GUIDANCE TUBE TO ABOUT WHERE THE OUTER TABLE OF THE BONE WOULD BE. A CT SCAN WAS AKEN AT THIS TIME AND THE TRAJECTORY WAS SUPERIOR AND ANTERIOR OF THE TARGET BY ABOUT 4MM. THE SURGEON ASSUMED THEINACCURACY WAS DUE TO THE AXIIS NOT BEING FIXATED SECURELY. THE SURGEON ATTEMPTED TO BETTER SECURE THE AXIIS AGAIN AND REPOSITION IT WITH THE ROSA BRAIN. AFTER ANOTHER CT, THE TARGET WAS ONCE AGAIN SUPERIOR AND ANTERIOR. THE SURGEON WENT BACK ONCE AGAIN AND TRIED USING ANOTHER AXIIS DEVICE, IN WHICH WE WAS ABLE TO GET IT SECURELY FIXATED TO THE SKULL. THE SURGEON THEN ATTEMPTED TO REPOSITION THE AXIIS TO BE ALIGNED WITH THE ROSA BRAIN 3 ADDITIONAL TIMES IN WHICH RESULTED IN THE TRAJECTORY STILL BEING OFF ALIGNMENT. ON THE LAST ATTEMPT, THE SURGEON TRIED TO ISOCENTRICALLY MOVE THE ROBOT ARM ABOUT THE ENTRY POINT TO COMPENSATE FOR THE ERROR THAT WAS OCCURRING. THE FINAL CT WAS PERFORMED AND THE SURGEON HAD PLACED THE MANDRAL INTO THE BRAIN AND DEPLOYED IT ABOUT 30MM PAST THE TARGET. THE CT SHOWED THIS RESULT AND THE TRAJECTORY WAS STILL OFF FROM THE TARGET. AT THIS TIME, THE SURGEON DECIDED TO ABORT THE CASE. WHEN UNDRAPING THE PATIENT, IT WAS FOUND THAT THE PATIENT HAD LACERATIONS TO THE HEAD DUE TO THE PINS OF THE DORO HEAD FIXATION DEVICE NOT BEING SECURELY FIXATED TO THE HEAD. THE SURGEON AGREED THAT THIS WAS THE REASON FOR THE INACCURACIES DURING THE CASE." }, { "mdr_text_key": "137946510", "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": "137946511", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "PATIENT WAS BROUGHT IN ROOM AND HEAD WAS FIXATED ONTO THE BED AS WELL AS BEING ATTACHED TO THE ROSA BRAIN. ONCE THE ROBOT WAS ATTACHED, IT WAS NOTICED THAT THE MONTERIS HEAD FIXATION WAS GOING TO BE IMPEDING WITH THE TRAJECTORY; THEREFORE, THE SURGEON AND THE OPERATING ROOM STAFF DECIDED TO UTILIZE THE DORO THREEPIN HEAD FIXATION DEVICE. THE SINGLE PIN WAS PLACED ON THE LEFT FOREHEAD NEAR THE HAIRLINE AND THE TWO-PIN SIDE WAS POSITIONED ON THE BACK RIGHT OF THE HEAD. THE PATIENTS WAS SUPINE WITH ABOUT A 60 DEGREE HEAD TILT TO THE LEFT. THE PATIENT THEN WAS CONNECTED DIRECTLY TO ROSA BRAIN. THE LASER REGISTRATION WAS PERFORMED. AFTER COMPLETING REGISTRATION, IT WAS THAT THE ROSA BRAIN STABILIZATION SYSTEM WAW NOT LOCKED DOWN. THE SURGEON WAS INFORMED AND INSTEAD OF RE-DOING REGISTRATION, HE DECIDED TO PERFORM THE VERIFICATION ONCE MORE WITH THE STABILIZATION SYSTEM LOCKED. RE-VERIFICATION SUCCESSFULLY PASSED. A CT SCAN WAS PERFORMED AND WAS MERGED TO ROSA. PATIENT WAS DRAPED AND THE PROCEDURE WAS READY TO BEGIN. THE PATIENT PREVIOUSLY HAD A CRANIOTOMY IN THIS AREA AND HAD A MESH PLATE IMPLANTED. THEREFORE, THE SURGEON COULD NOT PLACE A BOLT IN THIS AREA DUE TO THERE BEING NO BONE. THE SURGEON INSTEAD CUT AN AREA OF THE MESH PLATE AWAY AND USED A AXIIS DEVICE, WHICH IS A 3 LEGGED STABILIZATION DEVICE WITH LAG SCREWS TO FIXATE TO THE SKULL FOR ACCURATE PLACEMENT OF THE ABLATION PROBE. THE SURGEON ATTEMPTED TO PLACE THE AXIIS DEVICE BUT WASN¿T GETTING GOOD PURCHASE OF THE LAG SCREWS IN THE BONE. THE SURGEON ATTEMPTED TO PLACE THE AXIS WITH ROSA BRAIN GUIDANCE AND A MANDREL WAS PLACED IN THE AXIIS GUIDANCE TUBE TO ABOUT WHERE THE OUTER TABLE OF THE BONE WOULD BE. A CT SCAN WAS AKEN AT THIS TIME AND THE TRAJECTORY WAS SUPERIOR AND ANTERIOR OF THE TARGET BY ABOUT 4MM. THE SURGEON ASSUMED THE INACCURACY WAS DUE TO THE AXIIS NOT BEING FIXATED SECURELY. THE SURGEON ATTEMPTED TO BETTER SECURE THE AXIIS AGAIN AND REPOSITION IT WITH THE ROSA BRAIN. AFTER ANOTHER CT, THE TARGET WAS ONCE AGAIN SUPERIOR AND ANTERIOR. THE SURGEON WENT BACK ONCE AGAIN AND TRIED USING ANOTHER AXIIS DEVICE, IN WHICH WE WAS ABLE TO GET IT SECURELY FIXATED TO THE SKULL. THE SURGEON THEN ATTEMPTED TO REPOSITION THE AXIIS TO BE ALIGNED WITH THE ROSA BRAIN 3 ADDITIONAL TIMES IN WHICH RESULTED IN THE TRAJECTORY STILL BEING OFF ALIGNMENT. ON THE LAST ATTEMPT, THE SURGEON TRIED TO ISOCENTRICALLY MOVE THE ROBOT ARM ABOUT THE ENTRY POINT TO COMPENSATE FOR THE ERROR THAT WAS OCCURRING. THE FINAL CT WAS PERFORMED AND THE SURGEON HAD PLACED THE MANDRAL INTO THE BRAIN AND DEPLOYED IT ABOUT 30MM PAST THE TARGET. THE CT SHOWED THIS RESULT AND THE TRAJECTORY WAS STILL OFF FROM THE TARGET. AT THIS TIME, THE SURGEON DECIDED TO ABORT THE CASE. WHEN UNDRAPING THE PATIENT, IT WAS FOUND THAT THE PATIENT HAD LACERATIONS TO THE HEAD DUE TO THE PINS OF THE DORO HEAD FIXATION DEVICE NOT BEING SECURELY FIXATED TO THE HEAD. THE SURGEON AGREED THAT THIS WAS THE REASON FOR THE INACCURACIES DURING THE CASE." } ], "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": "01/29/2020" } ] }