{ "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": "3005985723-2021-00107", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20210621", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20210526", "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": "20210621", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "930379", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210621", "brand_name": "MAKO ROBOTIC ARM 3.1", "generic_name": "V", "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": "219999", "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": "07613327395280", "udi_public": "07613327395280", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Failure to Calibrate", "Computer Operating System Problem", "Failure to Calibrate", "Computer Operating System Problem" ], "reporter_state_code": "CO", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/15/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250729", "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": "20210621", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "No Clinical Signs, Symptoms or Conditions", "Unspecified Tissue Injury", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20211011", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "12032102", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20210526", "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": "326727976", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REPORTED EVENT: THE MPS REPORTED SURGEON REQUEST FOR SERVICE VISIT DUE TO INACCURATE CUTS DURING TKA CASE. MPS REPORTED THAT DOCTOR SAID THE CUTS FELT OFF IN TKA CASE AND THAT ANTERIOR CUT NOTCHED EVEN THOUGH IT SHOULD HAVE HAD ENOUGH FLEXION NOT TO. A COUPLE MONTHS AGO THIS SAME KIND OF ISSUE HAPPENED SO THE DOCTOR IS INSISTING FSE MAKE A VISIT. METHOD & RESULTS: -PRODUCT EVALUATION AND RESULTS: THE FIELD SERVICE ENGINEER REPORTED: PROBLEM REPRODUCED? NO. TROUBLE SHOOTING NOTES: NONE. WORK PERFORMED: MACHINE PASSED ALL TESTS ON ARRIVAL. DID A COMPLETE PM. MADE A FEW MINOR ADJUSTMENTS JUST TO OPTIMIZE TEST RESULTS. SYSTEM READY FOR USE. WORK ORDER DISPOSITION: SYSTEM INVESTIGATION COMPLETED SUCCESSFULLY AS PER SERVICE MANUAL. ALL SYSTEM CHECKS AND TESTS PASSED, SYSTEM IS READY 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 (B)(6) WAS INSPECTED 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: (B)(6) SHOWS 0 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE ALLEGED FAILURE MODE WAS NOT CONFIRMED. SUCCESSFULLY COMPLETED ALL CHECKS, VERIFICATIONS, AND CALIBRATIONS. SYSTEM IS READY FOR CLINICAL USE. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED. H3 OTHER TEXT : DEVICE NOT RETURNED." }, { "mdr_text_key": "326727977", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "CASE NUMBER: (B)(4): (B)(6) - MPS REPORTED SURGEON REQUEST FOR SERVICE VISIT DUE TO INACCURATE CUTS DURING TKA CASE. MPS REPORTED THAT DOCTOR SAID THE CUTS FELT OFF IN TKA CASE AND THAT ANTERIOR CUT NOTCHED EVEN THOUGH IT SHOULD HAVE HAD ENOUGH FLEXION NOT TO. A COUPLE MONTHS AGO THIS SAME KIND OF ISSUE HAPPENED SO THE DOCTOR IS INSISTING FSE MAKE A VISIT." }, { "mdr_text_key": "257148932", "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": "257148933", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "CASE NUMBER: (B)(4). MPS REPORTED SURGEON REQUEST FOR SERVICE VISIT DUE TO INACCURATE CUTS DURING TKA CASE. MPS REPORTED THAT DOCTOR SAID THE CUTS FELT OFF IN TKA CASE AND THAT ANTERIOR CUT NOTCHED EVEN THOUGH IT SHOULD HAVE HAD ENOUGH FLEXION NOT TO. A COUPLE MONTHS AGO THIS SAME KIND OF ISSUE HAPPENED SO THE DOCTOR IS INSISTING FSE MAKE A VISIT." } ], "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": "10/11/2021" } ] }