{ "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": "3005985723-2025-00377", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20250815", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250723", "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": "US", "manufacturer_contact_area_code": "201", "date_added": "20250815", "manufacturer_contact_f_name": "SANJANA", "device_date_of_manufacturer": "20220615", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1014491", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250815", "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": [ "Incorrect, Inadequate or Imprecise Result or Readings", "Adverse Event Without Identified Device or Use Problem", "Incorrect, Inadequate or Imprecise Result or Readings", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "MD", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/10/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251114", "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": "20250815", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Muscle/Tendon Damage", "Muscle/Tendon Damage" ] } ], "distributor_city": "", "date_report": "20251006", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "MAHWAH", "mdr_report_key": "22817297", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250723", "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": "377846523", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AFTER WE MADE OUR CUTS WITH THE MAKO DR. REALIZED THE POPLITEUS WAS CUT EITHER DURING TIBIAL CUT OR POSTERIOR FEMORAL CUT. CASE TYPE / APPLICATION: TKA 2.0." }, { "mdr_text_key": "382763284", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "NO NEW INFORMATION." }, { "mdr_text_key": "382763285", "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. METHOD & RESULTS -PRODUCT EVALUATION AND RESULTS: REVIEW OF THE CASE SESSION FILES NOTED THE FOLLOWING: \"THERE WERE TWO FACTORS THAT COULD HAVE RESULTED IN THE POPLITEUS MUSCLE BEING CUT. 1. EXTENDED BOUNDARIES USED IN ALL FEMUR CUTS. ADDS 2MM TO THE BOUNDING HAPTICS. SPECIFICALLY RELEVANT IS THE EXTENDED BOUNDARIES ENABLED IN THE POSTERIOR CUT, WHICH EXTENDS THE BOUNDARIES LATERALLY AT THIS CUT. 2. TIBIA PLAN OVERHANGS > 1MM. THIS OVERHANG IS ON THE POSTERIOR LATERAL OF THE TIBIA. WHEN EXTENDED BOUNDARIES ARE USED, THE APPLICATION USER GUIDE STATES THAT ¿DIRECT VISUALIZATION OF THE ANATOMY SHOULD BE MAINTAINED DURING CUTTING MODE, SO AS TO AVOID UNINTENDED CONTACT WITH SOFT TISSUE AND NEUROVASCULAR STRUCTURES.¿ 3. PLEASE NOTE THAT THE TUBEROSITY POINTS WERE NOT CAPTURED. THIS CAUSED THE ANTERIOR-POSTERIOR VERIFICATION POINT TO FAIL, INDICATING AN ANTERIOR POSTERIOR SHIFT IN THE BONE REGISTRATION. THIS ANTERIOR-POSTERIOR SHIFT MAY HAVE BEEN NOT ONLY TRANSLATIONAL BUT ROTATIONAL, PLACING THE PHYSICAL AND VIRTUAL BONES AT DIFFERENT LOCATIONS AND ORIENTATION. 4. THE BONE CHECKPOINT FOR THE FEMUR WAS ONLY CHECKED FOR THE ANTERIOR OR 1ST FEMORAL BONE RESECTION, IT WAS NOT CHECKED FOR THE REST OF THE CASE. THE INTEGRITY OF THE FEMORAL ARRAY FOR THE POSTERIOR RESECTION IS THEREFORE NOT KNOWN. 5. THE TOOL CHECKPOINT IS CHECKED DURING THE POSTERIOR FEMORAL RESECTION, AND THE VALUE IS CAUTIONARY. THIS TREND CONTINUES TO THE FINAL CHECK OF THE TOOL CHECKPOINT DURING THE NEXT CUT THE DISTAL BONE RESECTION WHICH IS ALSO CAUTIONARY. THERE IS ALSO A SUDDEN DISPLACEMENT OF 2.58 MM BETWEEN THE CAMERA AND BASE ARRAY IN THE POSTERIOR BONE RESECTION WHILE ENGAGED IN THE STEREOTACTIC FIELD. THESE INDICATIONS POINT TO A BASE ARRAY BUMP DURING THE POSTERIOR BONE RESECTION. THERE IS NO INDICATION OF A SYSTEM OR SOFTWARE MALFUNCTION. -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: A REVIEW OF COMPLAINTS IN TRACKWISE SHOWS NO OTHER SIMILAR COMPLAINTS FOR TKA SOFTWARE - 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." } ], "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": "10/06/2025" } ] }