{ "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": "MS.", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "WESTON", "manufacturer_contact_address_1": "RAHEEN BUSINESS PARK", "manufacturer_contact_pcity": "61498200", "event_type": "Injury", "report_number": "3005985723-2024-00271", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20241203", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20241115", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "NA", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "61498200", "noe_summarized": "1", "manufacturer_contact_l_name": "RYAN", "source_type": [ "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "33331", "manufacturer_g1_state": "FL", "reporter_country_code": "JA", "manufacturer_contact_area_code": "614", "date_added": "20241203", "manufacturer_contact_f_name": "ANNA", "device_date_of_manufacturer": "20201028", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2210044", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241203", "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": [ "Application Program Problem: Parameter Calculation Error", "Failure to Calibrate", "Application Program Problem: Parameter Calculation Error", "Failure to Calibrate" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/17/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "EI", "date_changed": "20250812", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "6149", "patient": [ { "patient_sequence_number": "1", "date_received": "20241203", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "83 YR", "patient_sex": "Male", "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": "20250408", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "LIMERICK", "mdr_report_key": "20833899", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20241115", "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": "358155252", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "MAKO BILATERAL PKA SURGERY WAS PERFORMED. HOWEVER, THE CUTTER CHECK COULD NOT BE PASSED JUST BEFORE THE FIRST TIBIAL BONE CUTTING. THE SURGEON HAD NO CHOICE BUT TO DISCONTINUE THE PKA AND CLOSED THE INCISION SITE. REVISION SURGERY (MANUAL PKA) IS PLANNED INSTEAD OF MAKO PKA." }, { "mdr_text_key": "358155253", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "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 IF ADDITIONAL INFORMATION BECOMES AVAILABLE." }, { "mdr_text_key": "367865780", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "MAKO BILATERAL PKA SURGERY WAS PERFORMED. HOWEVER, THE CUTTER CHECK COULD NOT BE PASSED JUST BEFORE THE FIRST TIBIAL BONE CUTTING. THE SURGEON HAD NO CHOICE BUT TO DISCONTINUE THE PKA AND CLOSED THE INCISION SITE. REVISION SURGERY (MANUAL PKA) IS PLANNED INSTEAD OF MAKO PKA." }, { "mdr_text_key": "367865781", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN EVENT REGARDING REGISTRATION FAILS INVOLVING A MAKO ROBOTIC ARM WAS REPORTED. THE EVENT WAS NOT CONFIRMED BECAUSE ROBOT WAS NOT INSPECTED. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: A REQUEST FOR A FIELD SERVICE ENGINEER INSPECTION WAS NOT MADE AND THE ROBOT WAS NOT INSPECTED. 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: THERE HAVE BEEN NO OTHER COMPLAINTS WITH SIMILAR EVENT(S) FOR THE LOT REFERENCED. CONCLUSIONS: THE ALLEGED FAILURE MODE WAS NOT CONFIRMED AS THERE HAS BEEN NO ONSITE INSPECTION BY A FIELD SERVICE ENGINEER. 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": "NA", "manufacturer_contact_exchange": "614", "manufacturer_contact_pcountry": "353", "suppl_dates_fda_received": "04/08/2025" } ] }