{ "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": "3009185973-2020-00129", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200527", "manufacturer_address_2": "", "pma_pmn_number": "K182848", "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": "20200527", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "558000", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200527", "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", "catalog_number": "ROSAS00201", "lot_number": "UNK", "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": [ "Malposition of Device", "Malposition of Device" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/15/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250810", "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": "20200527", "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": "20210115", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10090838", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200511", "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": "322652048", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT ONE OF THE IMPLANTED SCREW (L5 G) SKIVED. THE SURGEON HAD TO REPLACE THE SCREW PER OPERATIVELY BY A LARGER DIAMETER SCREW, RESULTING IN A POOR ACCURACY. REPORTEDLY, THIS ADVERSE EVENT HAPPENED BECAUSE THE ANCILLARY EQUIPMENT USED WAS NOT ADAPTED TO THE SCREW WHICH LED TO SCREW SHIFTING. BASED ON THE SURGEON DESCRIPTION, THERE IS NO EVIDENCE THAT THE ROSA ONE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. THE INSTRUCTIONS FOR USE 'FFR-056C-EN-USER MANUAL SPINE' INDICATED THAT FOR SCREW IMPLANTATION, THE USER HAS TO 'FOLLOW THE IMPLANT MANUFACTURER¿S RECOMMENDATIONS FOR TAPPING AND SCREW IMPLANTATION.'" }, { "mdr_text_key": "322652049", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON MAY 11, 2020 THE SURGEON SENT THE DATABASE ABOUT THE ONGOING PMCF FOR THE ROSA ONE DEVICE TO A ZIMMER BIOMET TEAM MEMBER. THIS TEAM MEMBER TRANSMITTED THE SERIOUS INJURY EVENTS IDENTIFIED IN THIS DATABASE TO THE COMPLAINT HANDLING TEAM ON (B)(6) 2020. PATIENT ID: NOT PROVIDED. SURGERY DATE: NOT PROVIDED. TYPE OF EVENT: ADVERSE EVENT (AE). SEVERITY: MILD. RELATION TO DEVICE: DEFINITELY. RELATION TO INSTRUMENT: DEFINITELY. RELATION TO PROCEDURE: NOT RELATED. DESCRIPTION: SKIVING OF THE L5 G SCREW (NOT ADAPTED ANCILLARY EQUIPMENT: PATHFINDER). REQUIRED TO REPOSITION THE SCREW PER OPERATIVELY. THE EFFECT WAS EXACERBATED BY THE ANCILLARY EQUIPMENT WHICH WASN'T GRIPPING WELL ENOUGH (NO AUTO TAP, REQUIRED A STRONG PRESSURE ON THE SPINE). SCREW REPOSITIONED WITHOUT ISSUE, BUT WITH GRADE C ACCURACY (ACCORDING TO THE GERTZBEIN AND ROBBINS CLASSIFICATION SYSTEM). REQUIRED THAT THE SECOND SCREW PLACED HAD A LARGER DIAMETER." }, { "mdr_text_key": "194953480", "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": "194953481", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2020 THE SURGEON SENT THE DATABASE ABOUT THE ONGOING PMCF FOR THE ROSA ONE DEVICE TO A ZIMMER BIOMET TEAM MEMBER. THIS TEAM MEMBER TRANSMITTED THE SERIOUS INJURY EVENTS IDENTIFIED IN THIS DATABASE TO THE COMPLAINT HANDLING TEAM ON (B)(6) 2020. PATIENT ID: NOT PROVIDED. SURGERY DATE: NOT PROVIDED. TYPE OF EVENT: ADVERSE EVENT (AE). SEVERITY: MILD. RELATION TO DEVICE: DEFINITELY. RELATION TO INSTRUMENT: DEFINITELY. RELATION TO PROCEDURE: NOT RELATED. DESCRIPTION: SKIVING OF THE L5 G SCREW (NOT ADAPTED ANCILLARY EQUIPMENT: PATHFINDER). REQUIRED TO REPOSITION THE SCREW PER OPERATIVELY. THE EFFECT WAS EXACERBATED BY THE ANCILLARY EQUIPMENT WHICH WASN'T GRIPPING WELL ENOUGH (NO AUTO TAP, REQUIRED A STRONG PRESSURE ON THE SPINE). SCREW REPOSITIONED WITHOUT ISSUE, BUT WITH GRADE C ACCURACY (ACCORDING TO THE (B)(4) CLASSIFICATION SYSTEM). REQUIRED THAT THE SECOND SCREW PLACED HAD A LARGER DIAMETER." } ], "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": "01/15/2021" } ] }