{ "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": "3005985723-2024-00138", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20240830", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20240806", "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": "AS", "manufacturer_contact_area_code": "201", "date_added": "20240830", "manufacturer_contact_f_name": "SANJANA", "device_date_of_manufacturer": "20200828", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1054738", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240830", "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": "ROB1271", "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": [ "Positioning Problem", "Positioning Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/20/2024", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250821", "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": "20240830", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other", " H", " R" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Damage to Ligament(s)", "Damage to Ligament(s)" ] } ], "distributor_city": "", "date_report": "20241015", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "MAHWAH", "mdr_report_key": "20112470", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240806", "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": "354408966", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "MED/POST HAPTICS WERE SO LARGE THAT IT ALLOWED SAW BLADE TO CUT SUPERFICIAL FIBERS OF THE MCL. PRODUCT MANAGEMENT HAVE BEEN MADE AWARE AND ARE SUBMITTING THIS CASE TO ENGINEERS IN US FOR AN EXPLANATION. ALL CASE DETAILS HAVE BEEN FORWARDED TO FSE TEAM REQUIRED LIGAMENT REPAIR AND TS POLY." }, { "mdr_text_key": "354408967", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REPORTED EVENT: AN EVENT REGARDING INACCURATE RESECTION INVOLVING A MAKO TKA SOFTWARE WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS. PRODUCT EVALUATION AND RESULTS: REVIEW OF THE CASE SESSION FILES NOTED THE FOLLOWING: THERE WAS IMPLANT OVERHANG ON THE MEDIAL SIDE IN THE REGION OF THE COLLATERAL LIGAMENT INSERTION. THE SURGEON IS RESPONSIBLE FOR THE IMPLANT PLAN. SHOULD THE SURGEON PLAN THE IMPLANT WITH OVERHANG THE SAW WILL CUT THE IMPLANT SHAPE AND ANYTHING THAT IS IN THE VOLUME OF THE IMPLANT WILL BE CUT. THE SYSTEM HAS NO KNOWLEDGE OF THE LOCATION OF THE COLLATERAL LIGAMENTS BUT HAS A TIGHTER MARGIN OF SAFETY ON THE MEDIAL AND LATERAL SIDES. THIS MARGIN OF SAFETY IS DECREASED WHEN THE EXTENDED HAPTICS ARE USED. THE USER IN THIS CASE USED EXTENDED HAPTICS FOR ALL CUTS MAKING THE MARGIN OF SAFETY NARROWER, IN ADDITION TO THE IMPLANT OVERHANG IN THE PLAN, ALLOWING THE USER TO CUT SURROUNDING SOFT TISSUES EASIER. THE TOOL AND BONE CHECKPOINTS WERE IN THE UNCERTAINTY YELLOW REGION. THE USER CHOSE TO RESECT BONE WHEN THE STABILITY OF THE ARRAYS WERE CAUTIONARY. CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ROB WAS INSPECTED ON 28 AUG 2020 AND THE QUALITY INSPECTION PROCEDURES WERE COMPLETED WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN TRACKWISE, SHOWS NO OTHER SIMILAR COMPLAINTS FOR TKA SOFTWARE, INACCURATE RESECTION. CONCLUSIONS: BASED ON THE ANALYSIS OF THE RELEVANT LOG FILES AND SESSION FILES, THE ALLEGED FAILURE MODE CAN BE CONFIRMED TO HAVE BEEN CAUSED BY USER ERROR. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED, THEN THE COMPLAINT WILL BE REOPENED." }, { "mdr_text_key": "350751543", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "MED/POST HAPTICS WERE SO LARGE THAT IT ALLOWED SAW BLADE TO CUT SUPERFICIAL FIBERS OF THE MCL PRODUCT MANAGEMENT HAVE BEEN MADE AWARE AND ARE SUBMITTING THIS CASE TO ENGINEERS IN US FOR AN EXPLANATION. ALL CASE DETAILS HAVE BEEN FORWARDED TO FSE TEAM REQUIRED LIGAMENT REPAIR AND TS POLY" }, { "mdr_text_key": "350751544", "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": "10/15/2024" } ] }