{
  "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,
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  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
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      "report_to_fda": "",
      "manufacturer_contact_t_name": "MR.",
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      "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": "3005985723-2026-00098",
      "type_of_report": [
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        "Followup"
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      "manufacturer_address_2": "",
      "pma_pmn_number": "",
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      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "07430",
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      "manufacturer_g1_postal_code": "33331",
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        {
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          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20260225",
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          "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT",
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          "manufacturer_d_address_1": "3365 ENTERPRISE AVE",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "WESTON",
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          "manufacturer_d_zip_code_ext": "",
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          "device_availability": "No",
          "device_report_product_code": "OLO",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "N",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Orthopedic Stereotaxic Instrument",
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        }
      ],
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        "Adverse Event Without Identified Device or Use Problem"
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      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "05/20/2026",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20260810",
      "health_professional": "Y",
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          "sequence_number_treatment": [
            ""
          ],
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          ],
          "patient_age": "NA",
          "patient_sex": "Unknown",
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          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Laceration(s)",
            "Muscle/Tendon Damage"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20260615",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "MAHWAH",
      "mdr_report_key": "24442528",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20260131",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      ],
      "manufacturer_g1_zip_code": "33331",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "MAKO SURGICAL CORP.",
      "adverse_event_flag": "Y",
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      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "N",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "393916032",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "THE FOLLOWING INFORMATION WAS PROVIDED: DURING MAKO TKA, WHEN MEASURING THE VIRTUAL GAP, THE INSERTION OF THE MEDIAL COLLATERAL LIGAMENT (MCL) TORE SLIGHTLY WHEN VALGUS STRESS WAS APPLIED. THE TORE PART WAS SUTURED."
        }
      ],
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      "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": "06/15/2026"
    }
  ]
}