{ "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": "3009185973-2022-00007", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20220223", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20220120", "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": "FR", "manufacturer_contact_area_code": "904", "date_added": "20220223", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20200916", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1006274", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20220223", "brand_name": "ROSA ONE", "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": "ROSA ONE", "catalog_number": "ROSAS00201", "lot_number": "3.1.5.28", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "HAW", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "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": [ "Malposition of Device", "Malposition of Device" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250808", "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": "20220223", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "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": "20220223", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "FR", "manufacturer_contact_city": "JACKSONVILLE", "mdr_report_key": "13585682", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220124", "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": "286009504", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THERE WAS AN INACCURACY OF ALMOST 10 MM FOR A POSTERIOR BIOPSY. BIOPSY WITHOUT OUTCOME, HAD TO BE TAKEN AGAIN." }, { "mdr_text_key": "286009604", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FULL ANALYSIS OF THE DEVICE DATA LOGS AND PATIENT EXAMS HAS BEEN PERFORMED. THIS ANALYSIS CONCLUDED THAT THE INACCURACY IS CONFIRMED FOR THE BIOPSY TRAJECTORY WITH A DEVIATION ESTIMATED AT 7.33MM. NO ROBOTIC ERROR WAS FOUND THROUGH THE ANALYSIS. THE ROOT CAUSE FOR THIS INACCURACY REMAINS UNKNOWN BUT MULTIPLE CAUSES ARE ASSUMED: THE REGISTRATION WAS NOT OPTIMAL AND MULTIPLE ELEMENTS RELATED TO THE REFERENCE IMAGE AND ITS RECONSTRUCTION IN THE SOFTWARE MIGHT HAVE PLAYED A ROLE IN THE SURGERY ACCURACY. IT IS POSSIBLE THAT THE HEAD HOLDER USED HAD A PLAY ON ITS MOUNTING AND THAT THE HEAD MOVED DURING THE SURGERY. THE PATIENT WOKE UP AFTER THE FIRST REGISTRATION ATTEMPTED. MICRO-MOVES OCCURRED SO THE REGISTRATION WAS RESTARTED BUT THE HEAD HOLDER WAS NOT RETIGHTENED AGAIN. IT IS THEN POSSIBLE THAT THE MOUNTING WAS WEAKENED. THE ANALYSIS AND THE COMPARISON WITH OTHER SIMILAR CASES ON THE SAME DEVICE ON THE PAST 3 MONTHS, DID NOT PERMIT TO IDENTIFY A REPETITIVE PATTERN. OTHER SIMILAR PROCEDURES USING SAME DEVICE AND TOOLS WERE PERFORMED FOR THE PAST 3 MONTHS WITH CORRECT ACCURACY. UNIQUE IDENTIFIER (UDI) #: (B)(4)." } ], "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": "" } ] }