{ "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": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "3005985723-2020-00292", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200901", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200806", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200901", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "944755", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200901", "brand_name": "MAKO ROBOTIC ARM 3.1", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MAKO SURGICAL CORP.", "manufacturer_d_address_1": "2555 DAVIE ROAD", "manufacturer_d_address_2": "", "manufacturer_d_city": "FORT LAUDERDALE", "manufacturer_d_state": "FL", "manufacturer_d_zip_code": "33317", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "33317", "device_operator": "HEALTH PROFESSIONAL", "model_number": "209999", "catalog_number": "219999", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00848486030407", "udi_public": "00848486030407", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Difficult or Delayed Positioning", "Difficult or Delayed Positioning" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/12/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250825", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200901", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient", "No Clinical Signs, Symptoms or Conditions", "No Known Impact Or Consequence To Patient", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210125", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10477462", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200806", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "322675898", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE PARTIAL KNEE CUTS WERE WAY OFF AND WE HAD TO BAIL TO A TKA. WE HAD COMPLETED THE CASE AND TRIALING WHEN THE SURGEON TOOK A CLOSER LOOK AND DID NOT LIKE THE WAY THE IMPLANTS WERE POSITIONED. WHAT IT LOOKED LIKE ON THE PLAN WAS NOT WHAT IT LOOKED LIKE ON THE PATIENT. WE HAD NO PROBLEMS WITH ANY CHECK POINTS OR MOVED ARRAYS DURING THE CASE AT ALL BUT THE CUTS WERE OFF CASE TYPE / APPLICATION: PKA (MICS). SURGICAL DELAY<= 15 MINUTES." }, { "mdr_text_key": "322675919", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REPORTED EVENT. AN EVENT REGARDING INACCURATE RESECTION INVOLVING A MAKO PKA SOFTWARE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS. -PRODUCT EVALUATION AND RESULTS: REVIEW OF THE CASE SESSION FILES NOTED THE FOLLOWING: REGISTRATION VALUES FOR BOTH BONE AND ROBOT REGISTRATION WERE WITHIN THE ACCEPTABLE RANGE. ALL PRE-SURGERIES PASSED. THE ONLY WARNING THAT WAS IDENTIFIED WAS THAT THE ROBOT WAS NOT FULLY SEATED DURING THE PROCEDURE. CUTTING VISUALS SHOW THAT CUTS ALONG THE PLATEAU ENTERED THE RED VISUAL AREA AS DID THE TIBIAL POST CUTS. THERE WAS NO EVIDENCE IDENTIFIED IN THE LOGS THAT WOULD SUGGEST THE PERFORMED RESECTION DID MATCH THE PLAN IMPLANT PLACEMENT. -CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ROB973 WAS INSPECTED ON 13/08/2019 AND THE QUALITY INSPECTION PROCEDURES WERE COMPLETED WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN TRACKWISE RELATED TO P/N 219999, ROBOT NUMBER: ROB973 SHOWS 0 SIMILAR COMPLAINTS FOR PKA SOFTWARE - INACCURATE RESECTION. CONCLUSIONS: THE ALLEGED FAILURE MODE WAS NOT CONFIRMED. THE DATA AT THIS TIME SHOWS THAT ALL SYSTEM VERIFICATION VALUES WERE WITHIN THE ACCURACY TOLERANCE REGION; NO SYSTEM DEFECT OR MALFUNCTION IS SUSPECTED." }, { "mdr_text_key": "205130642", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE." }, { "mdr_text_key": "205130643", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE PARTIAL KNEE CUTS WERE WAY OFF AND WE HAD TO BAIL TO A TKA. WE HAD COMPLETED THE CASE AND TRIALING WHEN THE SURGEON TOOK A CLOSER LOOK AND DID NOT LIKE THE WAY THE IMPLANTS WERE POSITIONED. WHAT IT LOOKED LIKE ON THE PLAN WAS NOT WHAT IT LOOKED LIKE ON THE PATIENT. WE HAD NO PROBLEMS WITH ANY CHECK POINTS OR MOVED ARRAYS DURING THE CASE AT ALL BUT THE CUTS WERE OFF. CASE TYPE / APPLICATION: PKA (MICS). SURGICAL DELAY<= 15 MINUTES." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "01/25/2021" } ] }