{ "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": "3009185973-2021-00103", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210421", "manufacturer_address_2": "", "pma_pmn_number": "K192173", "date_of_event": "20210324", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "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": "20210421", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "601719", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20210421", "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 3.1", "catalog_number": "ROSAS00203", "lot_number": "3.1.4.1650", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Mechanical Problem", "Mechanical Problem" ], "reporter_state_code": "WI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250814", "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": "20210421", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210723", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "11698827", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210324", "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": "325738259", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A DETAILED ANALYSIS OF THE DATA LOGS AND FILES RECEIVED HAS BEEN PERFORMED, AND THIS ANALYSIS CONCLUDED THAT THE DATA DO NOT PERMIT TO CONFIRM OR MEASURE INACCURACIES IN THE SCREWS POSITIONING. THE ANALYSIS OF AVAILABLE DATA DID NOT REVEAL ANY MALFUNCTION OF THE DEVICE DURING THE PROCEDURE. THE REGISTRATION WAS PROPERLY PERFORMED AND THE POSITON OF BOTH TRAJECTORIES WAS NEITHER ON THE SAME VERTEBRAE, NOR ON THE SAME SIDE. THEREFORE, NO DEVICE INVOLVEMENT COULD BE CONFIRMED FOR THE REPORTED ISSUE. THE CAUSE FOR THE EVENT REMAINS UNKNOWN." }, { "mdr_text_key": "325738260", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE SURGEON HAS TWO EVENTS RESULTING FROM IMPLANTED SCREWS NOT ACHIEVING THEIR PLANNED TRAJECTORY. LEFT L4 BREACHED LATERALLY AND RIGHT L5 BREACHED MEDIALLY. LEFT L4 BREACH ALSO CAUSED A K-WIRE TO ADVANCE BY AND PAST THE VERTEBRAL BODY. NO DAMAGE TO VERTEBRAE. SURGERY WAS EXTENDED IN ORDER TO REDIRECT THE AFFECTED SCREWS AND DIRECT THEM USING STANDARD TECHNIQUE TO ACCEPTABLE TRAJECTORIES. NO AFTER EFFECTS KNOWN." }, { "mdr_text_key": "247277540", "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. UNIQUE IDENTIFIER (UDI) #: (B)(4)." }, { "mdr_text_key": "247277541", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE SURGEON HAS TWO EVENTS RESULTING FROM IMPLANTED SCREWS NOT ACHIEVING THEIR PLANNED TRAJECTORY. LEFT L4 BREACHED LATERALLY AND RIGHT L5 BREACHED MEDIALLY. LEFT L4 BREACH ALSO CAUSED A K-WIRE TO ADVANCE BY AND PAST THE VERTEBRAL BODY. NO DAMAGE TO VERTEBRAE. SURGERY WAS EXTENDED IN ORDER TO REDIRECT THE AFFECTED SCREWS AND DIRECT THEM USING STANDARD TECHNIQUE TO ACCEPTABLE TRAJECTORIES. NO AFTER EFFECTS KNOWN." } ], "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": "07/23/2021" } ] }