{
  "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": {
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      "manufacturer_contact_zip_ext": "",
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      "report_to_fda": "",
      "manufacturer_contact_t_name": "MR.",
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      "manufacturer_link_flag": "Y",
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      "manufacturer_contact_address_1": "2560 GENERAL ARMISTEAD AVENUE",
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      "manufacturer_address_2": "",
      "pma_pmn_number": "D301521",
      "date_of_event": "20211020",
      "reprocessed_and_reused_flag": "N",
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      "exemption_number": "",
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      "reporter_occupation_code": "003",
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      "manufacturer_g1_postal_code": "19403",
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          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "U",
          "date_received": "20211119",
          "brand_name": "EXCELSIUS",
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          "manufacturer_d_name": "GLOBUS MEDICAL, INC.",
          "manufacturer_d_address_1": "2560 GENERAL ARMISTEAD AVENUE",
          "manufacturer_d_address_2": "",
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          "device_report_product_code": "OLO",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "N",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Orthopedic Stereotaxic Instrument",
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      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20250808",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
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          "sequence_number_treatment": [
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          "patient_age": "",
          "patient_sex": "Unknown",
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          "patient_race": "",
          "patient_problems": [
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            "Insufficient Information"
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        }
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      "distributor_city": "",
      "date_report": "20211108",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "AUDUBON",
      "mdr_report_key": "12846884",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20211022",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "19403",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "GLOBUS MEDICAL, INC.",
      "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": "281073234",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "INVESTIGATION REVEALED THERE WAS NO SYSTEM MALFUNCTION. FOR THE LEVEL OF L5-R, THE SOFTWARE DETECTED EXCESSIVE FORCES ON THE LOAD CELL DURING BONE WORK. THIS IS THE RESULT OF SKIVING FORCES DETECTED WHILE A TOOL IS INSERTED IN THE END EFFECTOR. SOFTWARE CORRECTLY DETECTED THE WARNING AND ALERTED THE USER. THE USER PROCEEDED WITH NAVIGATION AND PLACEMENT OF THE SCREW. THE CAUSE OF THE REPORTED ISSUE WAS TRACED TO USER TECHNIQUE."
        },
        {
          "mdr_text_key": "281073235",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT A REVISION SURGERY WAS DONE TO REPOSITION A MISPLACED L5 RIGHT SCREW."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "2560 GENERAL ARMISTEAD AVENUE",
      "distributor_zip_code": "",
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      "manufacturer_contact_exchange": "610",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}