{ "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": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "3005985723-2020-00328", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20201030", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20201006", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20201030", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1226713", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20201030", "brand_name": "MAKO ROBOTIC ARM 3.1", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MAKO SURGICAL CORP.", "manufacturer_d_address_1": "2555 DAVIE ROAD", "manufacturer_d_address_2": "", "manufacturer_d_city": "FORT LAUDERDALE", "manufacturer_d_state": "FL", "manufacturer_d_zip_code": "33317", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "33317", "device_operator": "HEALTH PROFESSIONAL", "model_number": "219999", "catalog_number": "219999", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "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": [ "Malposition of Device", "Malposition of Device" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/02/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250730", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20201030", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "76 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Insufficient Information", "No Clinical Signs, Symptoms or Conditions", "Insufficient Information", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210224", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10762235", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201006", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "322425391", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REPORTED EVENT: AN EVENT REGARDING INACCURATE RESECTION (NOTCHING) INVOLVING A MAKO TKA SOFTWARE WAS REPORTED. NOTCHING WAS CONFIRMED BY A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT HOWEVER THE FAILURE AGAINST THE MAKO ROBOT WAS NOT CONFIRMED AS A REVIEW OF THE LOG/SESSION FILES WAS NOT COMPLETED. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: REVIEW OF THE LOG/SESSION FILES HAS NOT BEEN COMPLETED WITHIN 90DAYS OF THE COMPLAINT BEING OPENED. THEREFORE, THE COMPLAINT WILL BE CLOSED WITH AN ASSOCIATED RISK ASSESSMENT. ADDITIONAL FAILURES WILL BE ASSESSED ONCE THE LOG/SESSION FILE REVIEW HAS BEEN COMPLETED. A REVIEW OF THE PROVIDED MEDICAL RECORDS CONFIRMED A LARGE NOTCH ANTERIORLY. CLINICIAN REVIEW: A REVIEW OF THE PROVIDED MEDICAL INFORMATION BY A CLINICAL CONSULTANT INDICATED: EVENT DATE: (B)(6) 2020 OPENED SAME. DESCRIPTION: DOCTOR COMPLAINED OF SMALL NOTCH ON ANTERIOR FEMUR. WENT TO RECUT ANTERIOR TO MAKE SURE BLADE WAS RUN OUT COMPLETELY. NOTCH INCREASED FURTHER. NO SURGICAL DELAY. IMPLANT: MAKO ROBOTIC ARM 3.1 DOCUMENTS: STRYKER PI REPORT, UNDATED LEFT LATERAL X-RAY POSTOP CEMENTED TRIATHLON PS WITH LARGE NOTCH. CONFIRMATION: THE EVENT WAS CONFIRMED. THERE WAS A LARGE NOTCH ANTERIORLY. ROOT CAUSE: THE ROOT CAUSE CANNOT BE ASCERTAINED. REVIEW OF THE OPERATIVE NOTE, THE MAKO PREOPERATIVE PLAN AND INTRAOPERATIVE PLAN CHANGES, IMPLANT RECORDS MAY PROVIDE INSIGHT AS TO THE ROOT CAUSE. PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT (B)(6) WAS INSPECTED ON 12 OCT 2019 AND THE QUALITY INSPECTION PROCEDURES WERE COMPLETED WITH NO REPORTED DISCREPANCIES COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN TRACKWISE RELATED TO P/N 219999, ROBOT NUMBER: (B)(6) SHOWS 0 SIMILAR COMPLAINTS FOR TKA SOFTWARE - INACCURATE RESECTION. CONCLUSIONS: THE ALLEGED FAILURE WAS NOT CONFIRMED HOWEVER NOTCHING WAS SHOWN ON A PROVIDED PRE-OP X-RAY AND LARGER NOTCHING WAS SHOWN ON A POST-OP X-RAY. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS MADE AVAILABLE FOR EVALUATION. REVIEW OF THE LOG/SESSION FILES HAS NOT BEEN COMPLETED WITHIN 90DAYS OF THE COMPLAINT BEING OPENED. A REVIEW OF THE CASE SESSION/LOG DATA IS NEEDED TO COMPLETE A FULL INVESTIGATION FOR DETERMINING ROOT CAUSE. IN ADDITION TO A REVIEW OF THE LOG/SESSION, A FIELD SERVICE ENGINEER CONDUCTS SCHEDULED MAINTENANCE ON THE ROBOT TO ENSURE THE ROBOT IS SYSTEM READY. ADDITIONAL INFORMATION SUCH AS A REVIEW OF THE OPERATIVE NOTES, THE MAKO PREOPERATIVE PLAN AND INTRAOPERATIVE PLAN CHANGES AND IMPLANT RECORDS MAY PROVIDE INSIGHT AS TO THE ROOT CAUSE. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED. H3 OTHER TEXT : DEVICE NOT RETURNED." }, { "mdr_text_key": "322425393", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DOCTOR COMPLAINED OF SMALL NOTCH ON ANTERIOR FEMUR. WENT TO RECUT ANTERIOR TO MAKE SURE BLADE WAS RUN OUT COMPLETELY. NOTCH INCREASED FURTHER. NO SURGICAL DELAY. CASE TYPE / APPLICATION: TKA." }, { "mdr_text_key": "213860161", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "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 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE." }, { "mdr_text_key": "213860162", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DOCTOR COMPLAINED OF SMALL NOTCH ON ANTERIOR FEMUR. WENT TO RECUT ANTERIOR TO MAKE SURE BLADE WAS RUN OUT COMPLETELY. NOTCH INCREASED FURTHER. NO SURGICAL DELAY. CASE TYPE / APPLICATION: TKA." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "02/24/2021" } ] }