{ "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": "3009185973-2019-00073", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190311", "manufacturer_address_2": "", "pma_pmn_number": "N/A", "date_of_event": "20190208", "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": [ "HEALTH PROFESSIONAL" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "FR", "manufacturer_contact_area_code": "", "date_added": "20190311", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "201610", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190311", "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": "LONG SPINE INSTRUMENT ADAPTOR", "catalog_number": "ROSAS00153", "lot_number": "ROSA3-120B", "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 Jam", "Mechanical Jam" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/24/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250731", "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": "20190311", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available", "No Code Available" ] } ], "distributor_city": "", "date_report": "20190925", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8407652", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190210", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Replace" ], "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": "312105654", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A SURGERY, A CANNULA GOT STUCK IN THE CANNULA ADAPTOR. A REVIEW OF THE DHR DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A REVIEW OF THE COMPLAINTS THAT OCCURRED IN THE PAST 12 MONTHS AND OF THE TWO LAST COMPLAINTS RECEIVED FOR THIS DEVICE DETERMINED THAT TWO SIMILAR COMPLAINTS WERE RECEIVED: ONE BEFORE AND ONE AFTER THE NOTIFICATION DATE. ANALYSIS OF THE RETURNED PRODUCT WAS PERFORMED AND SHOWED THAT TWO SCRATCHES ARE VISIBLE INSIDE THE HOLDER AND A FUNCTIONAL TEST SHOWED THAT IT WAS IMPOSSIBLE TO INSERT A CANNULA IN THE HOLDER. THE MOST PROBABLE ROOT CAUSE IS THAT SOMETHING SHARP ON THE CANNULA MADE THE SCRATCHES THAT ARE PRESENT INSIDE THE CANNULA HOLDER. PRODUCT INFORMATION PROVIDED IN THE PREVIOUS MEDWATCH ARE THE DATA OF THE CORE DEVICE. PRODUCT INFORMATION WAS CORRECTED TO GIVE THE INFORMATION OF THE CANNULA THAT WAS ANALYZED AT MANUFACTURING SITE. (B)(4)." }, { "mdr_text_key": "312105655", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT CANNULAS WERE BLOCKED INSIDE THEIR INSTRUMENT HOLDERS. THIS OCCURRED WITH SEVERAL SETS OF INSTRUMENTS THAT DAY. REPORTEDLY, THE SURGERY WAS DELAYED BY 3H (TOTAL SURGERY TIME : 6H INSTEAD OF 3H), WHICH IS CONSIDERED AS A SERIOUS INJURY. NO CLINICAL CONSEQUENCES FOR THE PATIENT WERE REPORTED OTHER THAN THE DELAY." }, { "mdr_text_key": "138369864", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UDI: (B)(4). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. THE DEVICE MODEL ROSA ONE IS NOT FDA CLEARED BUT IS SIMILAR TO THE DEVICE ROSA SPINE, CLASSIFIED OLO AND CLEARED UNDER K151511." }, { "mdr_text_key": "138369865", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT CANNULAS WERE BLOCKED INSIDE THEIR INSTRUMENT HOLDERS. THIS OCCURRED WITH SEVERAL SETS OF INSTRUMENTS THAT DAY. REPORTEDLY, THE SURGERY WAS DELAYED BY 3H (TOTAL SURGERY TIME : 6H INSTEAD OF 3H), WHICH IS CONSIDERED AS A SERIOUS INJURY. NO CLINICAL CONSEQUENCES FOR THE PATIENT WERE REPORTED OTHER THAN THE DELAY." } ], "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": "09/25/2019" } ] }