{ "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": "MS.", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "WESTON", "manufacturer_contact_address_1": "RAHEEN BUSINESS PARK", "manufacturer_contact_pcity": "61498200", "event_type": "Injury", "report_number": "3005985723-2024-00218", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20241025", "manufacturer_address_2": "", "pma_pmn_number": "K193515", "date_of_event": "20241001", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "NA", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "61498200", "noe_summarized": "1", "manufacturer_contact_l_name": "RYAN", "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": "614", "date_added": "20241025", "manufacturer_contact_f_name": "ANNA", "device_date_of_manufacturer": "20190307", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1812265", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241025", "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": "", "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", "Incorrect, Inadequate or Imprecise Result or Readings" ], "reporter_state_code": "ID", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "EI", "date_changed": "20250822", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "6149", "patient": [ { "patient_sequence_number": "1", "date_received": "20241025", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "65 YR", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20241025", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "LIMERICK", "mdr_report_key": "20535328", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20241001", "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": "355162948", "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 WERE NO INACCURATE CUTS SO INACCURACY IN CUTTING WAS DUE TO OTHER MECHANICAL OR SURGICAL TECHNIQUE ISSUES. MANY OF THE SURGICAL TECHNIQUE ISSUES ARE NOT VISIBLE IN THE LOGS. THE ROBOT WAS NOT LOWERED DURING THE ROBOT REGISTRATION STEP. THE ROBOTIC SYSTEM WILL NOT PERFORM WITHIN ITS ACCURACY SPECIFICATIONS IF THE USER FAILS TO LOWER THE ROBOT. FAILURE TO LOWER THE ROBOT CAN LEAD TO CUTTING INACCURACY OF 2 TO 3 MM. GENERAL TIPS FOR IMPROVING BONE RESECTION ACCURACY: CUTTING THE TIBIA PRIOR TO THE POSTERIOR FEMORAL RESECTION CAN PREVENT BLADE SKIVING. DOUBLE PASSING DOWN THE MIDDLE OF THE MIDDLE ANTERIOR CHAMFER MAY HELP ADDRESS INACCURACIES WITH THAT CUT. ANTERIOR CHAMFER GAP CAN BE RELATED TO INACCURACY IN THE OTHER FOUR BONE RESECTIONS AS THIS AFFECTS IMPLANT FIT. THE USER GUIDE PROVIDES THE FOLLOWING TIPS TO IMPROVE CUTTING ACCURACY: \"TO ENSURE ACCURACY, DO NOT EXERT STRONG FORCES ON THE ROBOTIC ARM, PARTICULARLY AS THE BLADE INITIALLY CONTACTS THE BONE. LARGE FORCES APPLIED TO THE CUTTING SYSTEM HANDLE MAY RESULT IN FLEXING OF THE BLADE.\" MAKO TKA APPLICATION USER GUIDE: CUT ACCURACY CAN BE IMPROVED BY SCORING THE BONE: \"TO MINIMIZE BLADE SKIVING, CAREFULLY SCORE THE BONE WITH THE SAW BLADE AS YOU ENTER THE CUT. IF THE BLADE IS DEFLECTED WHEN IT INITIALLY ENTERS THE BONES, IT WILL BE DIFFICULT TO ENSURE AN ACCURATE CUT UNLESS THE SAW BLADE IS REMOVED AND ENTRY POINT INTO THE BONE IS CORRECTED.\" TRIAL AND OR IMPLANT PLACEMENT WITH A LOT OF EXTENSION MAY CREATE GAPS IN THE OTHER RESECTIONS DUE TO BONE DEFORMATION. IT IS BEST TO MINIMIZE THIS JOINT MOTION OR CAMERA MOTION AS CHANGES IN CUTTING VOLUME BETWEEN ROBOT REGISTRATION AND BONE RESECTION WHEN THE VIZADISKS ARE UNSECURED OR DAMAGED WHICH IS A POTENTIAL CAUSE OF CUT-TO-CUT INACCURACY. PLEASE REFERENCE APPLICATION USER GUIDE FOR MORE TIPS ON IMPROVING CUT ACCURACY. THERE IS NO INDICATION OF SYSTEM OR SOFTWARE MALFUNCTION IN THE TKA 2.0 SOFTWARE OR THE MAKO SYSTEM. THE FIELD SERVICE ENGINEER REPORTED: CASE NUMBER: (B)(6), WORK ORDER: (B)(4). PROBLEM REPRODUCED: NO. TROUBLESHOOTING NOTES: ROB951 - MPS REPORTED THAT THE ANTERIOR CHAMFER CUT IS CONSTANTLY DEEP. WORK PERFORMED: SITE IS UNDER SERVICE CONTRACT AS OF 10/1/2024 AND NO LONGER BILLABLE. ARRIVED ONSITE AND WAS UNABLE TO REPLICATE ISSUE. THE J2 BUMP STOPS WERE SET TO THE REQUIRED 10 AND 32 DEGREES PER THE SERVICE MANUAL AND DID NOT REQUIRE ADJUSTMENT. RAN HOMING CONSTANTS/TRANSMISSION RATIO/ TRANSMISSION/PHASE CHECK/KINEMATIC CALIBRATION ALONG WITH OTHER TESTS. ALL TESTS WERE SUCCESSFUL AND DISPLAYED VALUES WITHIN OPTIMAL RANGE. REPLACED VEGA CAMERA AS A PRECAUTION AND UPLOADED ROBOTIC UTILITIES DISC 1.11.1 PER THE SERVICE MANUAL. PASSED RIO REGISTRATION WITH .51 ON THE RIGHT SIDE AND .97 ON THE LEFT SIDE. NO ISSUES FOUND. SYSTEM IS READY FOR CLINICAL USE. WORK ORDER DISPOSITION: SYSTEM INVESTIGATION COMPLETED SUCCESSFULLY AS PER SERVICE MANUAL. ALL SYSTEM CHECKS AND TESTS PASSED, SYSTEM IS READY FOR USE. -CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE ARE NO OTHER COMPLAINTS WITH A SIMILAR FAILURE MODE FOR THIS LOT. 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 (FAILURE TO LOWER THE ROBOT DURING RIO REGISTRATION). IN ADDITION, THE ALLEGED FAILURE MODE WAS NOT REPRODUCED DURING AN ONSITE INSPECTION, NO HARDWARE ISSUES WERE NOTED, HOWEVER THE SYSTEM WAS OPTIMIZED FOR CLINICAL USE. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED, THEN THE COMPLAINT WILL BE REOPENED." }, { "mdr_text_key": "355162949", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "MPS REPORTED THAT THE ANTERIOR CHAMFER CUT IS CONSTANTLY DEEP. THE MPS MENTIONED THAT THEY'VE BEEN GETTING SERVICE FOR THIS SAME ISSUE EVERY MONTH OR TWO FOR THE PAST YEAR. ON THE LAST CASE THE CUT WAS SO DEEP THAT THEY HAD TO GRAFT THE BONE TO GET THE IMPLANT TO FIT PROPERLY. MPS IS CONFIDENT THAT THE SURGEON IS NOT PUSHING AGAINST THE BUMP COMPLAINT FORM: - CUTS WITH THE ROBOT WERE INACCURATE. THIS HAS BEEN A CONSISTENT PROBLEM WITH MY ROBOT, WITH MANY SERVICE CALLS TO ADDRESS THIS ISSUE. ANTERIOR CHAMFER CUT WAS 2 TO 3 MM DEEP, HAD TO BONE GRAFT THE IMPLANT TO MAKE IT FIT- I DON'T THINK ITS A SURGEON TECHNIQUE ISSUE . HE REFUSED TO USE THE PLANAR PROBE. HE IS GETTING SO FRUSTRATED THAT CUTS ARE CONSISTENTLY OFF WITH THIS ROBOT HE IS THREATENING TO STOP USING THE ROBOT. CUTS WILL BE ACCURATE FOR A FEW WEEKS AFTER A SERVICE AND THEN CONSISTENTLY GET BAD AGAIN. I WOULD SAY 2 OR 3 TKA SURGERIES OUT OF FIVE WE WILL HAVE TO BONE GRAFT AT LEAST ONE PLACE ON THE FEMUR TO GET GOOD FIT WITH THE PRESS-FIT IMPLANTS. ROBOT NEEDS TO BE SERVICED. CASE TYPE / APPLICATION: TKA 2.0." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3365 ENTERPRISE AVE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "NA", "manufacturer_contact_exchange": "614", "manufacturer_contact_pcountry": "353", "suppl_dates_fda_received": "" } ] }