{ "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": "3005985723-2021-00067", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20210413", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20210318", "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": "20210413", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "556812", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210413", "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": [ "Computer Software Problem", "Incorrect, Inadequate or Imprecise Result or Readings", "Positioning Problem", "Computer Software Problem", "Incorrect, Inadequate or Imprecise Result or Readings", "Positioning Problem" ], "reporter_state_code": "ID", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/25/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20210413", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "41 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Laceration(s)", "Laceration(s)" ] } ], "distributor_city": "", "date_report": "20210720", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "11655844", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20210318", "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": "245125184", "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": "245125225", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DURING REAMING, THE FEMUR WAS INTERFERING WITH THE REAMER HANDLE AND THE SURGEON HAD TO PUSH HARD ANTERIOR IN ORDER TO GET POWER AND WE SAW RED IN THE POSTERIOR PORTION OF THE ACETABULUM ONCE REAMING WAS FINISHED. WHEN THE SURGEON REMOVED THE REAMER, HE DISCOVERED THAT HE HAD REAMED THROUGH THE POSTERIOR WALL. UPON REVIEWING THE PLANNED CUP, IT DID NOT SEEM PLAUSIBLE TO HAVE THAT RESULT. IT WAS THOUGHT THAT THE PERHAPS THE LEVERAGING AGAINST THE FEMUR CAUSED A MORE AGGRESSIVE POSTERIOR REAM. SURGICAL DELAY 16-30 MINUTES. CASE TYPE / APPLICATION: THA," }, { "mdr_text_key": "325712878", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REPORTED EVENT AN EVENT REGARDING INACCURATE REAMING INVOLVING A MAKO THA SOFTWARE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: REVIEW OF THE LOG/SESSION FILES HAS NOT BEEN COMPLETED WITHIN 60DAYS OF THE COMPLAINT BEING OPENED. THE COMPLAINT WILL BE CLOSED WITH AN ASSOCIATED RISK ASSESSMENT. ADDITIONAL FAILURES WILL BE ASSESSED ONCE THE LOG/SESSION FILE REVIEW HAS BEEN COMPLETED. CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ROB1060 WAS INSPECTED ON 19 DEC 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: ROB1060 SHOWS 0 SIMILAR COMPLAINTS FOR THA SOFTWARE - INACCURATE REAMING. CONCLUSIONS: 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 60DAYS 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. ONCE THE REVIEW OF THE LOG/SESSION FILES HAS BEEN COMPLETED THEN THE COMPLAINTS TEAM WILL REOPEN AND RE-EVALUATE THE COMPLAINT. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED. H3 OTHER TEXT : DEVICE NOT AVAILABLE." }, { "mdr_text_key": "325712879", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING REAMING, THE FEMUR WAS INTERFERING WITH THE REAMER HANDLE AND THE SURGEON HAD TO PUSH HARD ANTERIOR IN ORDER TO GET POWER AND WE SAW RED IN THE POSTERIOR PORTION OF THE ACETABULUM ONCE REAMING WAS FINISHED. WHEN THE SURGEON REMOVED THE REAMER, HE DISCOVERED THAT HE HAD REAMED THROUGH THE POSTERIOR WALL. UPON REVIEWING THE PLANNED CUP, IT DID NOT SEEM PLAUSIBLE TO HAVE THAT RESULT. IT WAS THOUGHT THAT THE PERHAPS THE LEVERAGING AGAINST THE FEMUR CAUSED A MORE AGGRESSIVE POSTERIOR REAM. SURGICAL DELAY 16-30 MINUTES. CASE TYPE / APPLICATION: THA." } ], "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": "07/20/2021" } ] }