{
  "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",
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    {
      "manufacturer_contact_zip_ext": "",
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      "report_to_fda": "N",
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      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Malfunction",
      "report_number": "3003853072-2020-00024",
      "type_of_report": [
        "Initial submission",
        "Followup"
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      "product_problem_flag": "Y",
      "date_received": "20200427",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K111301",
      "date_of_event": "20200401",
      "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": [
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        "FOREIG"
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      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "CH",
      "manufacturer_contact_area_code": "",
      "date_added": "20200427",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "466310",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20200427",
          "brand_name": "BLOCKER HOLDER",
          "generic_name": "INSTINCT JAVA SYSTEM",
          "manufacturer_d_name": "ZIMMER SPINE",
          "manufacturer_d_address_1": "23 PARVIS DES CHARTRONS",
          "manufacturer_d_address_2": "CITE MONDIALE",
          "manufacturer_d_city": "BORDEAUX, CEDEX",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "33080",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "FR",
          "manufacturer_d_postal_code": "33080",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "NA",
          "catalog_number": "046W1AN00590",
          "lot_number": "A2131702A",
          "other_id_number": "",
          "device_availability": "Device was returned to manufacturer",
          "date_returned_to_manufacturer": "20200603",
          "device_report_product_code": "NKB",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Thoracolumbosacral Pedicle Screw System",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3070",
            "device_class": "2"
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        }
      ],
      "product_problems": [
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        "Fracture"
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      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "11/17/2020",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250805",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
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      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20200427",
          "sequence_number_treatment": [
            "ITEM 046W1AN00640 LOT A2571907A."
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "84",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Known Impact Or Consequence To Patient",
            "No Known Impact Or Consequence To Patient"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20201118",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10001546",
      "removal_correction_number": "NA",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20200402",
      "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": "320417576",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "CMP-(B)(6). D4: UDI # (B)(4). G3: FOREIGN CHINA. THE COMPLAINT IS CONFIRMED FOR THE FAILURE OF DEFORMED TIP. MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. ROOT CAUSE WAS UNABLE TO BE DETERMINED. PER DHR REVIEW, THE PARTS WERE LIKELY CONFORMING WHEN THEY LEFT ZIMMER BIOMET CONTROL. NO ACTIONS REQUIRED. THIS EVENT IS NOT RELATED TO ANY CURRENT ACTIONS OR RECALLS OR PRODUCT HOLDS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS."
        },
        {
          "mdr_text_key": "320417577",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT."
        },
        {
          "mdr_text_key": "189593250",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. REFERENCE REPORT 3003853072-2020-00025."
        },
        {
          "mdr_text_key": "189593251",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT DURING THE PROCEDURE THE TIPS OF TWO DRIVERS FRACTURED. THE TIPS WERE RETRIEVED AND ALTERNATE DEVICES WERE USED TO COMPLETE THE CASE. THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT ONE OF TWO FOR THIS 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": "11/18/2020"
    }
  ]
}