{ "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": "3005985723-2025-00220", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20250515", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250423", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "07430", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "2018315000", "noe_summarized": "1", "manufacturer_contact_l_name": "SANTIAGO", "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": "201", "date_added": "20250515", "manufacturer_contact_f_name": "MARISOL", "device_date_of_manufacturer": "20231213", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2352716", "implant_date_year": "2025", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250515", "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": "ROB2599", "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": [ "Positioning Failure", "Incorrect, Inadequate or Imprecise Result or Readings", "Positioning Failure", "Incorrect, Inadequate or Imprecise Result or Readings" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/12/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260424", "health_professional": "Y", "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": "20250515", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention", " H" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Insufficient Information", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20260205", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "MAHWAH", "mdr_report_key": "22024294", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250423", "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": "370319682", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AS PART OF THE 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": "370320603", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING SURGERY AT MTKA, FEMORAL ROTATION ADJUSTMENT WAS LOST. THE OSTEOTOMY WAS PERFORMED WITH THE MEDIAL LOOSE. AFTER THE OSTEOTOMY, THE OSTEOPHYTE OF THE POSTERIOR CONDYLE WAS REMOVED. AS A RESULT, THE BALANCE WAS GOOD. ADDITIONAL OSTEOTOMY WAS PERFORMED." }, { "mdr_text_key": "394027401", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "NO NEW INFORMATION." }, { "mdr_text_key": "394027402", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN EVENT REGARDING INACCURATE RESECTION INVOLVING A MAKO TKA SOFTWARE WAS REPORTED. THE EVENT WAS NOT CONFIRMED BECAUSE THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: THE ALLEGED FAILURE MODE CANNOT BE DETERMINED BECAUSE THE RELEVANT LOG FILES AND CASE SESSION FILES WERE NOT AVAILABLE FOR INSPECTION. CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ROB2599 WAS INSPECTED 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 CANNOT BE DETERMINED BECAUSE THE RELEVANT LOG FILES AND CASE SESSION FILES WERE NOT AVAILABLE FOR INSPECTION. 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": "07430", "manufacturer_contact_exchange": "201", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "02/05/2026" } ] }