{
  "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": "2026-08-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2930
    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "",
      "report_to_fda": "",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Malfunction",
      "report_number": "1030489-2008-00081",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20080214",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K052261",
      "date_of_event": "20080122",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "PHYSICIAN",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
        "Company representation"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20080423",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1",
          "date_received": "20080214",
          "brand_name": "VERTE-STACK SPINAL SYSTEM",
          "generic_name": "VB REPLACEMENT",
          "manufacturer_d_name": "SOFAMOR DANEK DEGGENDORF GMBH",
          "manufacturer_d_address_1": "WERTSTRASSE 17",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "DEGGENDORF",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "9446",
          "manufacturer_d_zip_code_ext": "9",
          "manufacturer_d_country": "",
          "manufacturer_d_postal_code": "94469",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "NA",
          "catalog_number": "9193010",
          "lot_number": "MW48",
          "other_id_number": "NA",
          "device_availability": "Device was returned to manufacturer",
          "date_returned_to_manufacturer": "20080208",
          "device_report_product_code": "MQP",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "Y",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Spinal Vertebral Body Replacement Device",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3060",
            "device_class": "2",
            "registration_number": [
              "1030489"
            ],
            "fei_number": [
              "1000477302"
            ]
          }
        }
      ],
      "product_problems": [
        "Implant, removal of"
      ],
      "reporter_state_code": "VA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250818",
      "health_professional": "",
      "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": "20080214",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "UNK",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Surgical procedure, additional"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20080122",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "1000514",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20080122",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "N",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "17395134",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT A VERTEBRAL SPACER CRACKED DURING INSERTION. TWO THIRDS OF THE BROKEN DEVICE WAS IMPLANTED. NO PT COMPLICATIONS WERE REPORTED."
        },
        {
          "mdr_text_key": "17635997",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "A FRACTURED PORTION OF THE DEVICE WAS SENT TO THE MFR FOR EVAL. THE VISUAL MACROSCOPIC EXAM SHOWS THE IMPLANT WAS BROKEN. ONLY DISTAL PIECE OF IMPLANT WAS RETURNED. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECS. UNABLE TO DETERMINE THE CAUSE OF THE EVENT."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}