{ "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": "3005985723-2025-00067", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20250213", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250122", "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": "SANTIAGO", "source_type": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "33331", "manufacturer_g1_state": "FL", "reporter_country_code": "US", "manufacturer_contact_area_code": "201", "date_added": "20250213", "manufacturer_contact_f_name": "MARISOL", "device_date_of_manufacturer": "20220706", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2411111", "implant_date_year": "2025", "date_removed_year": "2025", "serviced_by_3rd_party_flag": "", "date_received": "20250213", "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", "Unintended Movement", "Incorrect, Inadequate or Imprecise Result or Readings", "Unintended Movement" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/27/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250805", "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": "20250213", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "NA", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Insufficient Information", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20250623", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "MAHWAH", "mdr_report_key": "21373510", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250122", "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": "376560736", "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 BECAUSE THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. 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 ROB2041 WAS INSPECTED ON (B)(6) 2022 AND THE QUALITY INSPECTION PROCEDURES WERE COMPLETED WITH NO 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": "376560737", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "NO NEW INFORMATION." }, { "mdr_text_key": "363523262", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING THE CASE DR KEPT COMPLAINING ABOUT CHATTER OR VIBRATION WHILE CUTTING. THIS MAY OR MAY NOT BE ASSOCIATED WITH WHAT IS TO COME. THE KNEE SEEMED GREAT BUT TIGHT WHILE TRIALING SO WE RESECTED A LITTLE MORE TIBIA. TRAILED AND CLOSED. THE POST OP XRAY SHOWED A TIBIAL TRAY THAT APPEARED TO THE DR TO BE IN AROUND 15 DEGREES OF VARUS. THE IMAGE WAS BAD ENOUGH THAT HE IMMEDIATELY WENT BACK IN TO REVISE THE KNEE. THE PHYSICIAN DID SAY A PIN SEEMED LOOSE WHEN REMOVING THE PINS BUT WE DID PASS CHECKPOINTS FOR THE ORIGINAL CUT AND THE RECUT AND HAD WHAT SEEMED TO BE A BALANCED KNEE. CASE TYPE / APPLICATION: TKA 2.0." }, { "mdr_text_key": "363523263", "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": "353", "suppl_dates_fda_received": "06/23/2025" } ] }