{ "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": "FL", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "WESTON", "manufacturer_contact_address_1": "RAHEEN BUSINESS PARK", "manufacturer_contact_pcity": "95462807", "event_type": "Injury", "report_number": "3005985723-2023-00132", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20230907", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20230815", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "NA", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "9546280700", "noe_summarized": "1", "manufacturer_contact_l_name": "RYAN", "source_type": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "33331", "manufacturer_g1_state": "FL", "reporter_country_code": "AS", "manufacturer_contact_area_code": "954", "date_added": "20230907", "manufacturer_contact_f_name": "ANNA", "device_date_of_manufacturer": "20230414", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2121035", "implant_date_year": "2023", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230907", "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": "ROB2296", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "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": [ "Fracture", "Fracture" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/11/2023", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "EI", "date_changed": "20250806", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9546", "patient": [ { "patient_sequence_number": "1", "date_received": "20230907", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "72 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Bone Fracture(s)", "Bone Fracture(s)" ] } ], "distributor_city": "", "date_report": "20231206", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "LIMERICK", "mdr_report_key": "17698546", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20230815", "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": "339058947", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE PATIENT SUFFERED AN ACETABULAR FRACTURE AS A RESULT OF THE PROCEDURE. THE SURGEON REPAIRED THE FRACTURE AND THE PROCEDURE COMPLETED SUCCESSFULLY." }, { "mdr_text_key": "339058948", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REPORTED EVENT. AN EVENT REGARDING INTRAOP FRACTURE INVOLVING A MAKO ROBOTIC ARM WAS REPORTED. THE EVENT WAS NOT CONFIRMED BECAUSE THE CASE SESSION DATA WAS NOT PROVIDED. METHOD & RESULTS. -PRODUCT EVALUATION AND RESULTS: REVIEW OF THE CASE SESSION FILES WAS NOT PERFORMED AS CASE SESSION DATA WAS NOT PROVIDED. A REVIEW OF SERVICE MAX DID NOT NOTE ANY ISSUES. AN ISSUE AGAINST THE SOFTWARE IS UNCLEAR. -CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS QUALITY INSPECTION PROCEDURES WERE COMPLETED WITH NO REPORTED DISCREPANCIES -COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS SHOWS 0 SIMILAR COMPLAINTS FOR ROBOTIC ARM - INTRAOP FRACTURE. CONCLUSIONS: THE ALLEGED FAILURE MODE CANNOT BE DETERMINED BECAUSE THE RELEVANT LOG FILES AND SESSION FILES WERE NOT AVAILABLE FOR INSPECTION. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED, THEN THE COMPLAINT WILL BE REOPENED." }, { "mdr_text_key": "322831670", "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 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE." }, { "mdr_text_key": "322831671", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE PATIENT SUFFERED AN ACETABULAR FRACTURE AS A RESULT OF THE PROCEDURE. THE SURGEON REPAIRED THE FRACTURE AND THE PROCEDURE COMPLETED SUCCESSFULLY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3365 ENTERPRISE AVE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "NA", "manufacturer_contact_exchange": "954", "manufacturer_contact_pcountry": "353", "suppl_dates_fda_received": "12/06/2023" } ] }