{ "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": "MR.", "manufacturer_contact_state": "NJ", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "WESTON", "manufacturer_contact_address_1": "325 CORPORATE DRIVE", "manufacturer_contact_pcity": "20183150", "event_type": "Injury", "report_number": "3005985723-2025-00316", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20250710", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250617", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "07430", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "2018315000", "noe_summarized": "1", "manufacturer_contact_l_name": "TALATHI", "source_type": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "33331", "manufacturer_g1_state": "FL", "reporter_country_code": "GM", "manufacturer_contact_area_code": "201", "date_added": "20250711", "manufacturer_contact_f_name": "SANJANA", "device_date_of_manufacturer": "20230622", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "402169", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250710", "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": "Yes", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "07613327395280", "udi_public": "07613327395280", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Application Program Problem", "Output Problem", "Application Program Problem", "Output Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/29/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260317", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "2018", "patient": [ { "patient_sequence_number": "1", "date_received": "20250710", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "NA", "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": "20251125", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "MAHWAH", "mdr_report_key": "22475905", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250617", "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": "374655182", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "VERIFICATION FAILED AND SUBSEQUENT AUTO ARM TEST ALSO FAILED. CABLE AND CAMERA CLEANED. ROBOT RESTARTED SEVERAL TIMES. ROBOT REPOSITIONED AND CAMERA ANGLE CHANGED. THE SURGERY WAS CANCELLED AND THE NEXT SURGERY IN THE OPERATING ROOM TOOK PLACE APPROXIMATELY ONE HOUR AFTER WE STARTED THE FAILED REGISTRATION OF THE ROBOT." }, { "mdr_text_key": "391212824", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN EVENT REGARDING NON-FUNCTIONAL INVOLVING A MAKO ROBOTIC ARM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: THE FIELD SERVICE ENGINEER REPORTED: PROBLEM REPRODUCED: NO. TROUBLESHOOTING NOTES: CABLE AND CAMERA CLEANED. ROBOT RESTARTED SEVERAL TIMES. ROBOT REPOSITIONED AND CAMERA ANGLE CHANGED. WORK PERFORMED: RAN PRE SURGERY CHECK ON GUD MODULE. RAN PHASE CHECK. RAN TRANSMISSION CHECK. RAN FRICTION CONSTANTS. RAN OPTICAL COMPLIANCE CHECK. RAN MICS STATUS CHECK. RAN FOOT PEDAL TEST. RAN KIN-CAL. RAN AUTO ARM ACCURACY CHECK. RAN CAMERA ACCURACY CHECK. RAN PRE SURGERY CHECK ON GUD MODULE. SYSTEM WAS CHECKED; SYSTEM IS READY FOR CLINICAL USE. WORK ORDER DISPOSITION: SYSTEM INVESTIGATION COMPLETED SUCCESSFULLY. ALL SYSTEM CHECKS AND TESTS PASSED, SYSTEM IS READY FOR USE. CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ROBOT WAS INSPECTED WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER COMPLAINTS WITH SIMILAR EVENT(S) FOR THE LOT REFERENCED. CONCLUSIONS: THE ALLEGED FAILURE MODE WAS NOT CONFIRMED. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED." }, { "mdr_text_key": "391212825", "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": "07430", "manufacturer_contact_exchange": "201", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "11/25/2025" } ] }