{ "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": "3005985723-2025-00130", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20250402", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250227", "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": "TALATHI", "source_type": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "33331", "manufacturer_g1_state": "FL", "reporter_country_code": "BR", "manufacturer_contact_area_code": "201", "date_added": "20250402", "manufacturer_contact_f_name": "SANJANA", "device_date_of_manufacturer": "20210715", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2846307", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250402", "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": "07613327395280", "udi_public": "07613327395280", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Incorrect, Inadequate or Imprecise Result or Readings", "Adverse Event Without Identified Device or Use Problem", "Incorrect, Inadequate or Imprecise Result or Readings", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/28/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251020", "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": "20250402", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Muscle/Tendon Damage", "Muscle/Tendon Damage" ] } ], "distributor_city": "", "date_report": "20250825", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "MAHWAH", "mdr_report_key": "21755731", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250311", "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": "382940417", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REPORTED EVENT: SURGEON COMPLAINED THAT DURING THE MAKO TKA SURGERY ON (B)(6) 2025, AFTER COMPLETING THE BONE CUTS, HE NOTICED AN INJURY IN THE PATIENT'S POPLITEAL. DOES THE CASE REFER TO A PRIMARY IMPLANT OR A REVISION? PRIMARY THE EVENT WAS NOT CONFIRMED BECAUSE THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. METHOD & RESULTS: -PRODUCT EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. -CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN OTHER COMPLAINTS WITH SIMILAR EVENT(S) FOR THE LOT REFERENCED. CONCLUSIONS: THE ALLEGED FAILURE MODE WAS NOT CONFIRMED BECAUSE THE PRODUCT WAS 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": "382940418", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "NO NEW INFORMATION." }, { "mdr_text_key": "367315551", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "SURGEON COMPLAINED THAT DURING THE MAKO TKA SURGERY, AFTER COMPLETING THE BONE CUTS, HE NOTICED AN INJURY IN THE PATIENT'S POPLITEAL. DOES THE CASE REFER TO A PRIMARY IMPLANT OR A REVISION? __PRIMARY__." }, { "mdr_text_key": "367315552", "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." } ], "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": "08/25/2025" } ] }