{ "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": "FL", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "WESTON", "manufacturer_contact_address_1": "3365 ENTERPRISE AVE", "manufacturer_contact_pcity": "95462807", "event_type": "Injury", "report_number": "3005985723-2025-00516", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20251110", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20251015", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "33331", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9546280700", "noe_summarized": "1", "manufacturer_contact_l_name": "CHAVEZ", "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": "954", "date_added": "20251110", "manufacturer_contact_f_name": "ALESSANDRA", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1490312", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251110", "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": "ROB1838", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "OLO", "device_age_text": "DAY", "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": [ "Adverse Event Without Identified Device or Use Problem", "Application Program Freezes or Fails to Launch", "Adverse Event Without Identified Device or Use Problem", "Application Program Freezes or Fails to Launch" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/27/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260327", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9546", "patient": [ { "patient_sequence_number": "1", "date_received": "20251110", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention", " H" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "Non Hispanic", "patient_race": "Asian", "patient_problems": [ "Insufficient Information", "No Clinical Signs, Symptoms or Conditions", "Insufficient Information", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260227", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "WESTON", "mdr_report_key": "23512322", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20251015", "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": "384736482", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE SCREEN FREEZES AFTER THE BONE REGISTRATION WAS COMPLETED AND BEFORE THE OSTEOTOMY. MPS TRIED EVERYTHING HE COULD DO TO FIX THE PROBLEM, BUT TO NO AVAIL, SO HE CONTACTED (B)(4). REBOOTING AND BYPASSING EACH CABLE DID NOT RESTORE THE SCREEN. THE DOCTOR IN CHARGE CONSULTED WITH THE PATIENT'S FAMILY AND REOPERATED AT A LATER DATE, CLOSING THE WOUND AND CLOSING IT." }, { "mdr_text_key": "395156554", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "NO NEW INFORMATION." }, { "mdr_text_key": "395156555", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN EVENT REGARDING APPLICATION FREEZE INVOLVING A MAKO ROBOTIC ARM WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -PRODUCT EVALUATION AND RESULTS: THE FIELD SERVICE ENGINEER REPORTED: PROBLEM REPRODUCED: YES. TROUBLESHOOTING NOTES: THE GUIDANCE SCREEN FROZE DURING SURGERY, AND EVEN AFTER RESTARTING, THE GUIDANCE PC WOULD NOT START UP. WORK PERFORMED: CONFIRMED THAT THE GUIDANCE PC WOULD NOT START UP ON SITE. SS2U REPLACEMENT (GUIDANCE PC), APPLICATION INSTALLATION AND IMPLANT SETTINGS, TIME SETTING. THE DEVICE WAS SET UP, THE J5 WIRE WAS ADJUSTED, AND PRE-SURGERY WAS PERFORMED. WORK ORDER DISPOSITION: FINALLY, WE PERFORMED A TEST AND CONFIRMED THAT IT WORKED PROPERLY. -CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT (B)(6) WAS INSPECTED AND THE QUALITY INSPECTION PROCEDURES WERE COMPLETED WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN OTHER COMPLAINTS WITH SIMILAR EVENT(S) FOR THE LOT REFERENCED. CONCLUSIONS: THE ALLEGED FAILURE MODE WAS CONFIRMED. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3365 ENTERPRISE AVE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "33331", "manufacturer_contact_exchange": "954", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "02/27/2026" } ] }