{ "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": "3005985723-2025-00394", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20250825", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250731", "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": "HK", "manufacturer_contact_area_code": "201", "date_added": "20250825", "manufacturer_contact_f_name": "MARISOL", "device_date_of_manufacturer": "20190620", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2191507", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250825", "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": "ROB944", "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": [ "Malposition of Device", "Malposition of Device" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/06/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260121", "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": "20250825", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "Non Hispanic", "patient_race": "Asian", "patient_problems": [ "Deformity/ Disfigurement", "Deformity/ Disfigurement" ] } ], "distributor_city": "", "date_report": "20251031", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "MAHWAH", "mdr_report_key": "22882048", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250801", "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": "378404581", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "MPS REPORTED AN INCIDENT DURING A MAKO KNEE CASE, WHERE THE SURGEONS THOUGHT THAT BOTH FEMUR AND TIBIA CUT WERE INACCURATE. THE INCORRECT CUTTING FOR BOTH FEMUR AND TIBIA HAS RESULTED IN MALPOSITION OF IMPLANT, COMPROMISING THE KNEE STABILITY. THE SESSION FILE WILL BE UPLOADED NEXT WEEK. PLEASE HELP INVESTIGATE THIS CASE AND GET BACK TO US ASAP. CASE TYPE/APPLICATION: (B)(4)." }, { "mdr_text_key": "390752468", "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: THE ROOT CAUSE OF THE REPORTED INACCURACIES IS A BUMPED ROBOTIC ARM BASE ARRAY OF 2.05 MM AND 1.05°. THE BONE RESECTIONS AFTER THE LAST GOOD TOOL CHECKPOINT AND BEFORE THE BASE ARRAY MOTION MAY HAVE INACCURATE RESECTION: ANTERIOR CHAMFER, POSTERIOR AND TIBIA BONE RESECTION. ADDITIONAL CONTRIBUTING FACTORS DETAILED BELOW: MID-RESECTION IMPLANT PLAN CHANGE WITHOUT REPEATING CUTS; MULTIPLE OCCURRENCES OF SUDDEN DISPLACEMENT FOR BASE ARRAY OR CAMERA; MULTIPLE CUTS PERFORMED FAR FROM ROBOT REGISTRATION CENTER. THE SURGEON SIGNIFICANTLY CHANGED THE IMPLANT PLAN MID-RESECTION AFTER THE POSTERIOR CHAMFER RESECTION, AND ONLY REPEATED THE DISTAL AND POSTERIOR CHAMFER BONE RESECTION. THE IMPLANT SHAPE CANNOT BE ACCURATE WHEN THE IMPLANT PLAN IS CHANGED MID-RESECTION WITHOUT REPEATING ALL BONE RESECTIONS AND CHANGING THE IMPLANT POSITION SO THAT MORE BONE NEEDS TO BE REMOVED FOR ALL CUTS. THERE WERE MULTIPLE OCCURRENCES OF SUDDEN DISPLACEMENT BETWEEN THE CAMERA AND BASE ARRAY WHICH MAY CORRESPOND TO THE BASE ARRAY MOTION NOTED ABOVE FROM THE ROBOT REGISTRATION TRANSFORM. WITH PROBE TO CHECKPOINT CHECKS GOING BEYOND THE ACCEPTABLE RANGE DURING THE LAST POSTERIOR CHAMFER RESECTION STEP. IT WAS ALSO NOTED THAT MULTIPLE CUTS WERE PERFORMED WITH THE END EFFECTOR AT A LARGE DISTANCE FROM ROBOT REGISTRATION CENTER. PERFORMING ROBOT REGISTRATION CLOSE TO THE POSITION WHERE RESECTION IS EXPECTED TO TAKE PLACE WILL IMPROVE BONE RESECTION ACCURACY. TIPS FOR IMPROVED BONE REGISTRATION: NOT CAPTURING THE CONDYLAR POINTS, TIBIAL TUBEROSITY POINTS, AND NOT ADHERING TO THE REGISTRATION PATTERN CAN LEAD TO AN ABSOLUTE POSITIONAL/ORIENTATIONAL ERROR FOR ALL CUTS, BUT NOT RELATIVE CUT-TO-CUT DISCREPANCIES. THERE IS NO EVIDENCE IN THIS CASE OF A BONE REGISTRATION FAILURE. PER THE TKA 2.0 APPLICATION USER GUIDE, \"THE TIBIAL REGISTRATION REQUIRES THE USER TO ACQUIRE POINTS ALONG THE TIBIAL TUBEROSITY. THESE POINTS ARE CRITICAL FOR THE SUCCESS OF THE REGISTRATION. IF ACQUIRED INCORRECTLY, IT IS LIKELY THAT INACCURACIES WILL BE INTRODUCED.\" THE USER GUIDE FURTHER STATES THAT \"POINTS SHOULD CORRESPOND TO BONE POSITIONS INDICATED ON SCREEN AND BE COLLECTED DIRECTLY ON THE BONE SURFACE. FAILURE TO COLLECT POINTS CORRECTLY MAY RESULT IN AN INACCURATE REGISTRATION AND INACCURATE BONE RESECTIONS.\" BONE REGISTRATION VERIFICATION WAS PERFORMED JUST BY ONE POINT IN THE FEMUR, THIS LIMITS THE DETERMINATION OF THE QUALITY OF BONE REGISTRATION. TIPS FOR IMPROVED HIP CENTER CAPTURE: THIS CASE HAS A HIGH CONDITION NUMBER, BUT A PASSING HIP CENTER, INDICATING A LARGER RANGE OF MOTION CAN IMPROVE THE HIP CENTER CAPTURE. HARDWARE AND SOFTWARE SYSTEMS FUNCTIONED WITHIN DESIGN PARAMETERS. PRE-SURGERY CHECKS PASSED, AND THE SYSTEM APPROPRIATELY DETECTED AND WARNED THE USER OF THE IMPLANT PLAN CHANGE. THIS CASE REPRESENTS A WORKFLOW ISSUE RATHER THAN A SYSTEM 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 (B)(6) WAS INSPECTED AND COMPLETED WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN TRACKWISE RELATED TO P/N 219999, ROBOT NUMBER: (B)(6) 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." }, { "mdr_text_key": "390752469", "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": "10/31/2025" } ] }