{ "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": "3005985723-2024-00264", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20241202", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20241113", "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": "JA", "manufacturer_contact_area_code": "201", "date_added": "20241202", "manufacturer_contact_f_name": "SANJANA", "device_date_of_manufacturer": "20231213", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "93774", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241202", "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": "ROB2599", "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": "04/11/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250812", "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": "20241202", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other", " H", " R" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Tissue Breakdown", "Muscle/Tendon Damage", "Tissue Breakdown", "Muscle/Tendon Damage" ] } ], "distributor_city": "", "date_report": "20250508", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "MAHWAH", "mdr_report_key": "20817983", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20241113", "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": "369866853", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN EVENT REGARDING INACCURATE RESECTION INVOLVING A MAKO ROBOTIC ARM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -PRODUCT EVALUATION AND RESULTS: A REQUEST FOR A FIELD SERVICE ENGINEER INSPECTION WAS NOT MADE AND THE ROBOT WAS NOT INSPECTED AS NO SERVICE MAX CASE & WORK ORDER EXISTS. -CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ROBOT 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. IF A FIELD SERVICE INSPECTION IS REQUESTED, FURTHER INVESTIGATION WILL BE COMPLETED ON THIS ISSUE. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED, THEN THE COMPLAINT WILL BE REOPENED." }, { "mdr_text_key": "369866854", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AFTER BONE CUTTING USING MAKO SYSTEM, IT WAS FOUND THAT THE POPLITEUS TENDON HAD BEEN CUT. AFTER THE FIRST BONE CUTTING OF THE FEMORAL POSTERIOR CONDYLE, THE BONE ON THE ANTERIOR SIDE BROKE AND BECAME DIFFICULT TO SEE, MAKING IT DIFFICULT TO SEE THE SURGICAL FIELD. ALTHOUGH THE DOCTOR WAS CONSCIOUS OF CUTTING ONLY THE NECESSARY SURFACE OF THE BONE, THE POPLITEUS TENDON MAY HAVE SHIFTED ANTERIORLY DUE TO THE BROKEN ANTERIOR BONE, CAUSING IT ENTERED THE BOUNDARY. THE CUTTING PART OF THE POPLITEUS TENDON WAS SUTURED, AND THE MAKO TKA WAS COMPLETED." }, { "mdr_text_key": "357975938", "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": "357975939", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AFTER BONE CUTTING USING MAKO SYSTEM, IT WAS FOUND THAT THE POPLITEUS TENDON HAD BEEN CUT. AFTER THE FIRST BONE CUTTING OF THE FEMORAL POSTERIOR CONDYLE, THE BONE ON THE ANTERIOR SIDE BROKE AND BECAME DIFFICULT TO SEE, MAKING IT DIFFICULT TO SEE THE SURGICAL FIELD. ALTHOUGH THE DOCTOR WAS CONSCIOUS OF CUTTING ONLY THE NECESSARY SURFACE OF THE BONE, THE POPLITEUS TENDON MAY HAVE SHIFTED ANTERIORLY DUE TO THE BROKEN ANTERIOR BONE, CAUSING IT ENTERED THE BOUNDARY. THE CUTTING PART OF THE POPLITEUS TENDON WAS SUTURED, AND THE MAKO TKA WAS COMPLETED." } ], "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": "05/08/2025" } ] }