{
  "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": "3005985723-2026-00174",
      "type_of_report": [
        "Initial submission",
        "Followup"
      ],
      "product_problem_flag": "N",
      "date_received": "20260413",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K241011",
      "date_of_event": "20260319",
      "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": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20260413",
      "manufacturer_contact_f_name": "SANJANA",
      "device_date_of_manufacturer": "20241028",
      "previous_use_code": "R",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "915123",
          "implant_date_year": "2026",
          "date_removed_year": "2026",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20260413",
          "brand_name": "MAKO 4 ROBOTIC ARM",
          "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": "229999",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "Yes",
          "device_report_product_code": "OLO",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "Y",
          "combination_product_flag": "N",
          "udi_di": "07613327624304",
          "udi_public": "07613327624304",
          "openfda": {
            "device_name": "Orthopedic Stereotaxic Instrument",
            "medical_specialty_description": "Neurology",
            "regulation_number": "882.4560",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Malposition of Device"
      ],
      "reporter_state_code": "TX",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "06/08/2026",
      "mfr_report_type": "Follow-Up",
      "manufacturer_contact_country": "US",
      "date_changed": "20260706",
      "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": "20260413",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Hospitalization",
            " R"
          ],
          "patient_age": "NA",
          "patient_sex": "Unknown",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Insufficient Information"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20260706",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "MAHWAH",
      "mdr_report_key": "24865804",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20260319",
      "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": "398306453",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "THE FOLLOWING INFORMATION WAS PROVIDED: THIS PI IS FOR THE HIP CASE ROBOT REPORT TO HAVING ISSUES WITH REGISTRATION. BLADE REGISTRATIONS AND CHECK POINTS. CUTS WERE EXAMINED TO BE OFF ON KNEE - HIP REGISTRATION WAS OFF. CASE TYPE / APPLICATION: THA 5.0. WO: (COMPLETED ON 3/20 TO ADDRESS THIS ISSUE AND REPORTED ON 3/20) MPS REPORTED ISSUES REGISTERING THE ROBOT. PERFORMED A FULL PM PROCEDURE. ALL TESTS PASSED AND THE SYSTEM IS READY FOR USE. UPDATE: THE INITIAL CASE HAPPENED THURSDAY 3/19. AFTER THE PATIENT WAS IN POSTOP AN X-RAY WAS TAKEN AND IT WAS FOUND THAT THE CUP AND AUGMENT WAS NOT WHERE THE SURGEON HAD EXPECTED. THE PATIENT WAS RESCANNED THAT NIGHT AND WE PERFORMED ANOTHER MAKO HIP SURGERY THE NEXT DAY TO CORRECT PLACEMENT OF THE CUP AND AUGMENT."
        }
      ],
      "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": "07/06/2026"
    }
  ]
}