{ "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": "CENTENNIAL PARK, ELSTREE", "manufacturer_g1_city": "WESTON", "manufacturer_contact_address_1": "325 CORPORATE DRIVE", "manufacturer_contact_pcity": "20183150", "event_type": "Injury", "report_number": "3005985723-2023-00103", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20230609", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20230323", "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": "TH", "manufacturer_contact_area_code": "201", "date_added": "20230609", "manufacturer_contact_f_name": "MARISOL", "device_date_of_manufacturer": "20190823", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2135935", "implant_date_year": "2023", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230609", "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": "219999", "catalog_number": "219999", "lot_number": "ROB1318", "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": [ "Incorrect, Inadequate or Imprecise Result or Readings", "Incorrect, Inadequate or Imprecise Result or Readings" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/18/2023", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250731", "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": "20230609", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "66 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Ambulation or Postural Difficulties", "Ambulation or Postural Difficulties" ] } ], "distributor_city": "", "date_report": "20230907", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "MAHWAH", "mdr_report_key": "17097982", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20230518", "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": "334868744", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED BY THE SALES REP \"ON 18MAY23 THE SURGEON WAS SHOWN THE POST-OP X-RAY THAT HAS ANTERIOR NOTCHING FROM MAKO RIGHT TKA ON (B)(6) 2023. THE PATIENT CAN NOT FULL WAIT BEARING\"." }, { "mdr_text_key": "334868745", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REPORTED EVENT. AN EVENT REGARDING NOTCHING INVOLVING A MAKO TKA SOFTWARE WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS. -PRODUCT EVALUATION AND RESULTS: BASED ON THE ANALYSIS OF THE RELEVANT LOG FILES AND SESSION FILES: THE INVESTIGATION OF THE SESSION INCLUDING CRISIS LOGS AND VPLOGS WAS EXECUTED. AN ANALYSIS OF THE CHECKPOINT CHECK VALUES, BONE REGISTRATION VALUES, PROBE CHECK VALUES, RIO REGISTRATION AND VERIFICATION VALUES, BONE PREPARATION CHECKPOINTS VALUE AND WARNINGS & ERRORS, WAS DONE. THERE ARE FEW MAIN OBSERVATIONS FROM THE ANALYSIS BASED ON THE EVENT DESCRIPTION. 1. ALL THE APPLICATION SPECIFIC PARAMETERS ARE WITHIN THE ACCEPTABLE LIMITS. 2. WARNING AND ERRORS HAVE SHOWN LOG ENTRIES: A. FOR HIP CENTER, ERROR IS HIGHER THAN THE THRESHOLD. 3. THE BONE REGISTRATION ACCURACY WAS UNCERTAIN DUE TO HIP CENTER ERROR BEING HIGH. THIS WAS ALSO SHOWN AS A WARNING MESSAGE TO THE USER BUT THE USER WENT AHEAD IGNORING THE WARNING MESSAGE. THIS WILL CREATE UNCERTAINTY IN THE CUTS¿ ACCURACY WHICH THE APPLICATION CAN¿T MEASURE. 4. THE CUTTING TOOL LOCATION ANALYSIS SHOWS THAT ALL THE CUTS WERE VERY CLOSE WITH RESPECT TO THE PLAN. THE CUT ANALYSIS PERFORMED HERE, THOUGH ONLY AN ESTIMATE, IS BASED ON THE BURRLIST POINTS GENERATED FROM THE SAWBLADE¿S LOCATION. THERE IS A HIGH CHANCE THAT DUE TO UNCERTAIN BONE REGISTRATION, THE CUTS MAY BE INACCURATE, AND THE ANTERIOR CUT WOULD HAVE CREATED NOTCHING. SINCE THERE WAS UNCERTAINTY IN THE REGISTRATION, THE APPLICATION COULDN¿T HAVE IDENTIFIED THE NOTCHING IN PLANNING AND EVENTUALLY WHEN THE CUTS EXECUTED. IT IS IMPORTANT TO MENTION THAT THE APPLICATION BEHAVED AS EXPECTED BY GENERATING THE WARNING MESSAGE FOR UNCERTAIN BONE REGISTRATION AND SUGGESTED THE USER TO CAPTURE RE-DO THE REGISTRATION WHICH WAS IGNORED BY THE USER. THIS WOULD HAVE LED TO INACCURATE ANTERIOR CUT AND NOTCHING. -CLINICIAN REVIEW: BASED OF THE LATERAL VIEW X-RAY OF A TKA WELL AS AN AP LEG LENGTH STUDY - \"THE X-RAY PROVIDED DEMONSTRATES A LATERAL VIEW OF A PRESSFIT TKA. IT SHOWS THAT THE FEMORAL COMPONENT IS IN AN EXTENDED POSITION NOTCHING THE ANTERIOR CORTEX. ANTERIOR FEMORAL NOTCHING IS CONFIRMED. THE ROOT CAUSE OF THIS CANNOT BE DETERMINED BY THIS LIMITED INFORMATION PROVIDED\". -PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT (B)(6) WAS INSPECTED AND THE QUALITY INSPECTION PROCEDURES WERE COMPLETED WITH NO REPORTED DISCREPANCIES -COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 219999, ROBOT NUMBER: (B)(6) SHOWS NO OTHER COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE ALLEGED FAILURE MODE WAS CONFIRMED TO BE CAUSED BY THE BONE REGISTRATION ACCURACY WAS UNCERTAIN DUE TO HIP CENTER ERROR BEING HIGH. THIS WAS ALSO SHOWN AS A WARNING MESSAGE TO THE USER BUT THE USER WENT AHEAD IGNORING THE WARNING MESSAGE. THIS WILL CREATE UNCERTAINTY IN THE CUTS¿ ACCURACY WHICH THE APPLICATION CAN¿T MEASURE. THERE IS A HIGH CHANCE THAT DUE TO UNCERTAIN BONE REGISTRATION, THE CUTS MAY BE INACCURATE, AND THE ANTERIOR CUT WOULD HAVE CREATED NOTCHING. SINCE THERE WAS UNCERTAINTY IN THE REGISTRATION, THE APPLICATION COULDN¿T HAVE IDENTIFIED THE NOTCHING IN PLANNING AND EVENTUALLY WHEN THE CUTS EXECUTED. IT IS IMPORTANT TO MENTION THAT THE APPLICATION BEHAVED AS EXPECTED BY GENERATING THE WARNING MESSAGE FOR UNCERTAIN BONE REGISTRATION AND SUGGESTED THE USER TO CAPTURE RE-DO THE REGISTRATION WHICH WAS IGNORED BY THE USER. THIS WOULD HAVE LED TO INACCURATE ANTERIOR CUT AND NOTCHING. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED." }, { "mdr_text_key": "316873633", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED BY THE SALES REP \"ON (B)(6) 2023 THE SURGEON WAS SHOWN THE POST-OP X-RAY THAT HAS ANTERIOR NOTCHING FROM MAKO RIGHT TKA ON (B)(6) 2023. THE PATIENT CAN NOT FULL WAIT BEARING\"." }, { "mdr_text_key": "316873634", "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. H3 OTHER TEXT : DEVICE NOT RETURNED." } ], "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": "44", "suppl_dates_fda_received": "09/07/2023" } ] }