{ "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": "FL", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "WESTON", "manufacturer_contact_address_1": "3365 ENTERPRISE AVE", "manufacturer_contact_pcity": "95462807", "event_type": "Injury", "report_number": "3005985723-2026-00053", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260206", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20260108", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "33331", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "9546280700", "noe_summarized": "1", "manufacturer_contact_l_name": "CHAVEZ", "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": "", "date_added": "20260206", "manufacturer_contact_f_name": "ALESSANDRA", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "341086", "implant_date_year": "2026", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260206", "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": "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", "Unintended Movement" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/20/2026", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260513", "health_professional": "N", "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": "20260206", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Muscle/Tendon Damage" ] } ], "distributor_city": "", "date_report": "20260319", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "WESTON", "mdr_report_key": "24277105", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260108", "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": "401115770", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "NO NEW INFORMATION." }, { "mdr_text_key": "401115771", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REPORTED EVENT AN EVENT REGARDING UNINTENDED MOVEMENT INVOLVING A MAKO TKA SOFTWARE WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS PRODUCT EVALUATION AND RESULTS: INVESTIGATION AND ROOT CAUSE TO BE ASSESSED UNDER NC. CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ROB1470 WAS INSPECTED 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: ROB1470 SHOWS NO OTHER SIMILAR COMPLAINTS FOR TKA SOFTWARE - UNINTENDED MOVEMENT. CONCLUSIONS: THE ALLEGED FAILURE MODE WAS CONFIRMED. INVESTIGATION AND ROOT CAUSE WILL BE FURTHER ASSESSED UNDER NC. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED." }, { "mdr_text_key": "392288171", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE FOLLOWING INFORMATION WAS PROVIDED: THE ROBOTIC ARM DROPPED WHEN THE SURGEON MOVED IT TO ALIGN THE ANTERIOR PLANE, CAUSING THE SAW TO DAMAGE THE PATIENT¿S MUSCLE AND SKIN. THE SURGEON HAD NOT TRIGGERED THE MICS YET. THE MPS PRESSED THE E-STOP AND MOVED THE ROBOT OUT OF THE PATIENT, THEN CLICKED ¿CONTINUE¿ ON THE SCREEN. AFTER THAT, THE MPS MOVED THE ROBOT BACK IN AND CONTINUED THE CASE. UPDATE FROM CALL WITH MPS - (B)(6): 1. EXPERIENCED SURGEON (5YEAR MAKO USER, 500+ CASES), STATED THAT HE WAS THAILAND¿S PROCTOR SURGEON, EXPERIENCED SURGEON WHO OBSERVES AND EVALUATES OTHER SURGEONS. 2. THE ARM DROPPING CAUSED A PUNCTURE INTO THE PATIENTS VASTUS MEDIALIS MUSCLE CAUSING A PARTIAL TEAR, STATED 5MM 3. MENTIONED 10-15 MIN DELAY, TOTAL DELAY FOR A MAKO RECHECK BEFORE RECOMMENCING WITH THE CASE AND FOR THE SUTURE REPAIR. 4. THE ROBOTIC ARM DROPPED AT BEGINNING OF THE CASE BEFORE ANY CUTS WERE MADE. 5. THAILAND TEAM LOOKING TO SEE IF THIS OCCURRED PREVIOUSLY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3365 ENTERPRISE AVE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "33331", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "03/19/2026" } ] }