{
  "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": "3005985723-2026-00121",
      "type_of_report": [
        "Initial submission",
        "Followup"
      ],
      "product_problem_flag": "N",
      "date_received": "20260303",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K172219",
      "date_of_event": "20260209",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "07430",
      "reporter_occupation_code": "PHYSICIAN",
      "manufacturer_contact_plocal": "2018315000",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "SRINIVASAN",
      "source_type": [
        "Health Professional"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "33331",
      "manufacturer_g1_state": "FL",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20260303",
      "manufacturer_contact_f_name": "DEEPAN RAJU",
      "device_date_of_manufacturer": "20221208",
      "previous_use_code": "I",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "553750",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20260303",
          "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": [
        "Application Program Problem: Parameter Calculation Error"
      ],
      "reporter_state_code": "PA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "06/15/2026",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20260710",
      "health_professional": "Y",
      "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": "20260303",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Other"
          ],
          "patient_age": "64 YR",
          "patient_sex": "Female",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Perforation"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20260710",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "MAHWAH",
      "mdr_report_key": "24494745",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20260209",
      "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": "Y",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "394440924",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT DURING A RIGHT MAKO TKA 2.0 PROCEDURE, THE PATIENT'S POPLITEAL ARTERY WAS NICKED. THE SURGEON DID EXTEND THE BOUNDARIES ON CUTS, BUT IT IS NOT KNOWN AT WHAT POINT DURING THE PROCEDURE THE ARTERY WAS NICKED. ISSUE WAS NOTICED WHEN THE SURGEON WAS CLEANING OUT POSTERIOR OSTEOPHYTES. A FEMORAL POPLITEAL BYPASS WAS PERFORMED TO ADDRESS THE ISSUE. SURGERY WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 1.5 TO 2 HOURS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "3365 ENTERPRISE AVE",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "07430",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": "07/10/2026"
    }
  ]
}