{ "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": "3005985723-2025-00518", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20251110", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20251014", "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": "SANTIAGO", "source_type": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "33331", "manufacturer_g1_state": "FL", "reporter_country_code": "AS", "manufacturer_contact_area_code": "201", "date_added": "20251110", "manufacturer_contact_f_name": "MARISOL", "device_date_of_manufacturer": "20240503", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "732103", "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": "ROB2817", "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": "07613327395280", "udi_public": "07613327395280", "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": "11/28/2025", "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": "20251110", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention", " H" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Insufficient Information", "No Clinical Signs, Symptoms or Conditions", "Insufficient Information", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20251218", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "MAHWAH", "mdr_report_key": "23512484", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20251014", "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": "384904195", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DEEP LATERAL ANTERIOR CUT RELATIVE THE IMPLANT, OTHER CUTS FLUSH. GRAFTING REQUIRED UNDER THE CUT. ADDITIONAL INFORMATION RECEIVED ON 14/10/25: THERE WAS A GAP BETWEEN THE IMPLANT AND THE CUT THAT THE SURGEON SAID WAS 5MM. HOWEVER, IN THE PICTURE IT LOOKS SLIGHTLY LESS. THERE HAS NOT BEEN ANY IMPACT OR ADVERSE CONSEQUENCES REPORTED SINCE AS A RESULT OF THIS EVENT EXCEPT FOR THE REQUIRED GRAFTS AS MENTIONED." }, { "mdr_text_key": "395753305", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REPORTED EVENT: AN EVENT REGARDING INACCURATE RESECTION INVOLVING A MAKO TKA SOFTWARE WAS REPORTED. THE EVENT WAS CONFIRMED DUE TO USER ERROR. METHOD & RESULTS: -PRODUCT EVALUATION AND RESULTS: REVIEW OF THE CASE SESSION FILES NOTED THE FOLLOWING: \" THE ROOT CAUSE OF INACCURATE RESECTIONS MAY BE ATTRIBUTED TO MULTIFACTORIAL CAUSES SEE ITEMS 1 ¿ 3: 1. TRANSIENT BONE ARRAY MOTION DURING POSTERIOR LATERAL BONE RESECTION. 2. MAKO PARK WAS NOT USED, AND THE LEG TILT, AND JOINT FLEXION WERE NOT IN THE RECOMMENDED RANGES, MAKING SYSTEM SETUP SUBOPTIMAL (FLEXION EXTENSION 95°-110°), (TILT -6° TO 0°), KNEE HEIGHT ± 25 MM. MAKO PARK SETUP THE CORRECT DISTANCE FROM ROBOT REGISTRATION CENTER AS WELL AS OPTIMAL JOINT ORIENTATION. TO OPTIMIZE FOR ACCURACY, IT IS RECOMMENDED THAT MAKO PARK IS USED. 3. ¿THE BASE ARRAY¿ SHOULD BE CENTRALLY POSITIONED IN CAMERA VIEW¿. FAILURE TO CENTER ARRAYS MAY LEAD TO CAMERA ERRORS AND AFFECT RESECTION ACCURACY. THE FOLLOWING IMPROVEMENTS TO THE WORKFLOW CAN SET THE MAKO SYSTEM UP FOR OPTIMAL RESECTION ACCURACY. ¿ BONE REGISTRATION PASSED FOR BOTH BONE THE FEMUR AND THE TIBIA. HOWEVER, FAILURE TO CAPTURE THE TIBIAL TUBEROSITY CLOUD POINTS MAY CAUSE A TIBIAL REGISTRATION FAILURE IN FUTURE CASES. ¿ THE HIP CENTER FOR THIS CASE PASSED AND DID NOT CONTRIBUTE TO POOR BONE REGISTRATION, BUT HIP CENTER QUALITY METRICS INDICATE A LIMITED RANGE OF MOTION FOR THIS CASE WHICH IS A RISK FACTOR FOR FUTURE BONE REGISTRATION FAILURES.¿ PIVOT THE LEG ABOUT THE HIP JOINT IN AN EXPANDING SPIRAL MOTION.¿ ¿ THE TIBIAL AND FEMORAL ARRAY WERE NOT VISIBLE THOUGH OUT THE CASE WHICH MAY INDICATE A SUBOPTIMAL SYSTEM SETUP (E.G., FLEXION VALUE ON JOINT POSITION RECORDED AS N/A) DUE TO THE ABSENCE OF ARM LOGS, WE WERE UNABLE TO ASCERTAIN WHETHER THE SYSTEM MET THE REQUIRED MECHANICAL READINESS 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 ROB2817 WAS INSPECTED ON WITH NO REPORTED DISCREPANCIES -COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN TRACKWISE RELATED TO P/N 219999, ROBOT NUMBER: ROB2817 SHOWS NO OTHER SIMILAR COMPLAINTS FOR INACCURATE RESECTION. CONCLUSIONS: BASED ON THE ANALYSIS OF THE RELEVANT LOG FILES AND SESSION FILES, THE ALLEGED FAILURE MODE CAN BE CONFIRMED TO HAVE BEEN CAUSED BY USER ERROR. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED, THEN THE COMPLAINT WILL BE REOPENED." }, { "mdr_text_key": "395753306", "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": "12/18/2025" } ] }