{ "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": "", "manufacturer_g1_city": "WESTON", "manufacturer_contact_address_1": "325 CORPORATE DRIVE", "manufacturer_contact_pcity": "20183150", "event_type": "Injury", "report_number": "3005985723-2023-00131", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20230907", "manufacturer_address_2": "", "pma_pmn_number": "K172219", "date_of_event": "20230815", "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": "TALATHI", "source_type": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "33331", "manufacturer_g1_state": "FL", "reporter_country_code": "AS", "manufacturer_contact_area_code": "201", "date_added": "20230907", "manufacturer_contact_f_name": "SANJANA", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2120999", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230907", "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": "ROB1066", "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": [ "Data Problem", "Data Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/11/2023", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250819", "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": "20230907", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "64 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Insufficient Information", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20240103", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "MAHWAH", "mdr_report_key": "17697770", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20230815", "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": "340133773", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE FOLLOWING WAS REPORTED: - CT SCAN WAS UPLOADED WITH INCORRECT TITLE WITH WRONG SIDE. PATIENT REFERRAL HAD CORRECT SIDE. - RADIOLOGIST ARE STATING THEY WEREN'T ABLE TO AMEND THE SIDE ON THE UPLOADED SCAN. - AS A RESULT, SCAN WAS SENT FOR A PLAN WITH THE INCORRECT SIDE (NO BOOKING RECEIVED TO CROSS REFERENCE AT THE TIME) - ON THE DAY OF OPERATING, NO-ONE WAS MADE AWARE UNTIL THE FIRST INCISION WAS MADE. DR INFORMED IMMEDIATELY. - DR MADE THE DECISION TO BAIL OUT OF THE PROCEDURE, SEW UP AND WAKE THE PATIENT (POST ANESTHETIC). DR STATED THE PATIENT HAD REQUESTED A ROBOTIC PROCEDURE." }, { "mdr_text_key": "340133774", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REPORTED EVENT. AN EVENT REGARDING INCORRECT PATIENT DATA INVOLVING AN UNKNOWN UNKNOWN APPLICATION WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS. -PRODUCT EVALUATION AND RESULTS: REVIEW OF THE CASE FILES NOTED THE FOLLOWING: SEQUENCE OF EVENTS: 1. THE RADIOLOGIST UPLOADED CT EXAM WITH WRONG OPERATIVE SIDE INDICATED IN THE MRN, UNBEKNOWNST TO MPS. 2. MPS SHARED THE EXAM WITH THE SEGMENTATION TEAM. 3. THE SEGMENTATION TEAM DOWNLOADED, PLANNED, AND SEGMENTED THE FILES BASED OFF THE MRN DETAILS. 4. THE RADIOLOGIST THEN CHANGED THE MRN TO REFLECT THE CORRECT OPERATIVE SIDE (AT THIS TIME THE CASE WAS ALREADY SEGMENTED BY THE SEGMENTATION TEAM. 5. THE RADIOLOGIST DID NOT INFORM ANYONE OF THE CHANGE. 6. AS PER EVENT DETAILS, ON THE DAY THE OPERATION TOOK PLACE, NEITHER THE SURGEON OR MPS NOTICED THAT THE INCORRECT PATIENT SIDE WAS SEGMENTED. 7. THE PLAN WAS CREATED OFF THE WRONG SIDE AND NOT CROSS REFERENCED/REVIEWED PRIOR TO THE PATIENT GOING UNDER ANESTHESIA. 8. SURGERY WAS RESCHEDULED AND COMPLETED THE FOLLOWING SATURDAY. -CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT INSERT ROBOT NUMBER 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 UNKNOWN, ROBOT NUMBER: INSERT ROBOT NUMBER SHOWS UNKNOWN APPLICATION - INCORRECT PATIENT DATA. CONCLUSIONS: THE ALLEGED FAILURE MODE WAS CONFIRMED TO HAVE BEEN CAUSED BY USER ERROR. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED." }, { "mdr_text_key": "322808882", "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 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE." }, { "mdr_text_key": "322808883", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE FOLLOWING WAS REPORTED: CT SCAN WAS UPLOADED WITH INCORRECT TITLE WITH WRONG SIDE. PATIENT REFERRAL HAD CORRECT SIDE. RADIOLOGIST ARE STATING THEY WEREN'T ABLE TO AMEND THE SIDE ON THE UPLOADED SCAN. AS A RESULT, SCAN WAS SENT FOR A PLAN WITH THE INCORRECT SIDE (NO BOOKING RECEIVED TO CROSS REFERENCE AT THE TIME) ON THE DAY OF OPERATING, NO-ONE WAS MADE AWARE UNTIL THE FIRST INCISION WAS MADE. DR INFORMED IMMEDIATELY. DR MADE THE DECISION TO BAIL OUT OF THE PROCEDURE, SEW UP AND WAKE THE PATIENT (POST ANESTHETIC). DR STATED THE PATIENT HAD REQUESTED A ROBOTIC PROCEDURE." } ], "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": "", "suppl_dates_fda_received": "01/03/2024" } ] }