{ "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": "3009185973-2019-00160", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190507", "manufacturer_address_2": "", "pma_pmn_number": "K101791", "date_of_event": "20190409", "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", "DISTRI" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "IN", "manufacturer_contact_area_code": "", "date_added": "20190507", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "379107", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190507", "brand_name": "ROSA SURGICAL DEVICE", "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", "catalog_number": "ROSAS00006", "lot_number": "2.5.8.4", "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": [ "Mechanical Problem", "Mechanical Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/14/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250811", "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": "20190507", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available", "No Code Available" ] } ], "distributor_city": "", "date_report": "20200915", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8585901", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190409", "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": "320050231", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. IT WAS REPORTED THAT THE FORCE SENSOR CABLE AND CONNECTOR GOT DAMAGED DURING A SURGERY. THE PARTS WERE NOT RETURNED AT THE MANUFACTURING SITE FOR INVESTIGATION, HOWEVER THE DAMAGE IS CONFIRMED BASED ON THE PICTURES PROVIDED BY THE REPORTER. A DISCUSSION WITH THE DISTRIBUTOR INDICATED THAT THE PARTS GOT DAMAGED BY ACCIDENT DURING A ROBOT ARM MOVEMENT (THE SURGEON WAS DRIVING THE ROBOT ARM FOR PLACING THE SECOND ELECTRODE). THEREFORE THE ROOT CAUSE IS DETERMINED TO BE AN UNINTENDED USE ERROR." }, { "mdr_text_key": "320050232", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE INDIAN DISTRIBUTOR INFORMED A ZIMMER BIOMET TEAM MEMBER ON (B)(6) 2019 THAT THE FORCE SENSOR CABLE AND CONNECTOR GOT DAMAGED DURING A SURGERY. NO CASUALTIES AND THE CASE WAS COMPLETED AFTER FIXING THE CABLE." }, { "mdr_text_key": "144256715", "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.  TYPE OF REPORTABLE EVENT: SERIOUS INJURY: THE ISSUE DELAYED THE SURGERY BY MORE THAN 30 MINUTES. (B)(4)." }, { "mdr_text_key": "144256716", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE (B)(4) DISTRIBUTOR INFORMED A ZIMMER BIOMET TEAM MEMBER ON (B)(6) 2019 THAT THE FORCE SENSOR CABLE AND CONNECTOR GOT DAMAGED DURING A SURGERY. NO CASUALTIES AND THE CASE WAS COMPLETED AFTER FIXING THE CABLE." } ], "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": "09/15/2020" } ] }