{ "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": "", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "WESTON", "manufacturer_contact_address_1": "RAHEEN BUSINESS PARK", "manufacturer_contact_pcity": "61498200", "event_type": "Injury", "report_number": "3005985723-2025-00276", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20250620", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250427", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "NA", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "61498200", "noe_summarized": "1", "manufacturer_contact_l_name": "RYAN", "source_type": [ "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "33331", "manufacturer_g1_state": "FL", "reporter_country_code": "JA", "manufacturer_contact_area_code": "614", "date_added": "20250620", "manufacturer_contact_f_name": "ANNA", "device_date_of_manufacturer": "20221212", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "256096", "implant_date_year": "2025", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250620", "brand_name": "MAKO ROBOTIC ARM 3.1", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MAKO SURGICAL CORP.", "manufacturer_d_address_1": "3365 ENTERPRISE AVE", "manufacturer_d_address_2": "", "manufacturer_d_city": "WESTON", "manufacturer_d_state": "FL", "manufacturer_d_zip_code": "33331", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "33331", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "219999", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "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": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/29/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "EI", "date_changed": "20251017", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "6149", "patient": [ { "patient_sequence_number": "1", "date_received": "20250620", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Aneurysm", "Pain", "Aneurysm", "Pain" ] } ], "distributor_city": "", "date_report": "20250923", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "LIMERICK", "mdr_report_key": "22296762", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250429", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "33331", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MAKO SURGICAL CORP.", "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": "373365131", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE." }, { "mdr_text_key": "373365132", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE FOLLOWING WAS REPORTED \"A PATIENT WHO HAD UNDERGONE MAKO-PKA SURGERY ON (B)(6) COMPLAINED OF PAIN IN THE SURGICAL SITE ABOUT A WEEK LATER. THE PHYSICIAN CONFIRMED BY MRI THAT AN ARTERY ABOUT 1 MM IN DIAMETER ON THE POSTERIOR MEDIAL SIDE HAD SUFFERED VASCULAR DAMAGE LEADING TO AN ANEURYSM. THE PATIENT UNDERWENT ENDOVASCULAR CATHETERIZATION TO TREAT THE ANEURYSM.\"" }, { "mdr_text_key": "382778516", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REPORTED EVENT AN EVENT REGARDING PAIN INVOLVING A MAKO ROBOTIC ARM WAS REPORTED. THE EVENT WAS NOT CONFIRMED BECAUSE THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. METHOD & RESULTS -PRODUCT EVALUATION AND RESULTS: THE ALLEGED FAILURE CANNOT BE DETERMINED TO BE CAUSED DUE TO ROBOTIC ARM AS THE REQUIRED INFORMATION WAS NOT AVAILABLE. -CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT THE ROBOT WAS INSPECTION WAS COMPLETED WITH NO REPORTED DISCREPANCIES -COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS SHOWS NO OTHER COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE ALLEGED FAILURE CANNOT BE DETERMINED TO BE CAUSED DUE TO ROBOTIC ARM AS THE REQUIRED INFORMATION WAS NOT AVAILABLE. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED." }, { "mdr_text_key": "382778517", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "NO NEW INFORMATION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3365 ENTERPRISE AVE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "NA", "manufacturer_contact_exchange": "614", "manufacturer_contact_pcountry": "353", "suppl_dates_fda_received": "09/23/2025" } ] }