{
  "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": {
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      "manufacturer_contact_zip_ext": "",
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      "event_location": "",
      "report_to_fda": "",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "NAPLES",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "80093370",
      "event_type": "Injury",
      "report_number": "1220246-2026-02940",
      "type_of_report": [
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      "product_problem_flag": "N",
      "date_received": "20260521",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20250613",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "501",
      "manufacturer_contact_plocal": "8009337001",
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      "manufacturer_contact_l_name": "ENGLE",
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      "manufacturer_g1_postal_code": "341081945",
      "manufacturer_g1_state": "FL",
      "reporter_country_code": "CA",
      "manufacturer_contact_area_code": "800",
      "date_added": "20260521",
      "manufacturer_contact_f_name": "JARED",
      "previous_use_code": "I",
      "device": [
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          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1304910",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20260521",
          "brand_name": "UNK",
          "generic_name": "POLYETHYLENE SYNTHETIC SUTURE",
          "manufacturer_d_name": "ARTHREX, INC.",
          "manufacturer_d_address_1": "1370 CREEKSIDE BOULEVARD",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "NAPLES",
          "manufacturer_d_state": "FL",
          "manufacturer_d_zip_code": "34108",
          "manufacturer_d_zip_code_ext": "1945",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "341081945",
          "device_operator": "HEALTH PROFESSIONAL",
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          "catalog_number": "UNK",
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          "device_evaluated_by_manufacturer": "N",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Suture, Nonabsorbable, Synthetic, Polyethylene",
            "medical_specialty_description": "General, Plastic Surgery",
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            "device_class": "2"
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      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20260526",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "1945",
      "manufacturer_contact_extension": "73216",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "8009",
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          "sequence_number_treatment": [
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          "sequence_number_outcome": [
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          ],
          "patient_age": "NA",
          "patient_sex": "Unknown",
          "patient_weight": "",
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          "patient_race": "",
          "patient_problems": [
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      ],
      "distributor_city": "",
      "date_report": "20260521",
      "initial_report_to_fda": "No",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "",
      "mdr_report_key": "25243443",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20260501",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "34108",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "ARTHREX, INC.",
      "adverse_event_flag": "Y",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "Y",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "401923446",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "ON 01-MAY-2026, A NOTIFICATION WAS RECEIVED VIA EMAIL INDICATING THAT INFORMATION HAD BEEN OBTAINED FROM A CLINICAL STUDY, A PILOT STUDY TO EVALUATE THE EFFICACY OF BIOCARTILAGE MICRONIZED CARTILAGE MATRIX IN MICROFRACTURE TREATMENT OF OSTEOCHONDRAL DEFECTS OF THE TALUS (US-01096). THE FOLLOWING EVENTS WERE REPORTED: ONE (1) RETURN TO THE OPERATING ROOM FOR REMOVAL OF A FIBERWIRE STITCH WITH NEGATIVE CULTURES; ONE (1) INFECTED SUTURE; ONE (1) REPORT OF NUMBNESS OF THE LEFT FOOT FOLLOWING A SECOND SURGERY; ONE (1) EVENT ASSESSED AS LIKELY RELATED TO A PERIPHERAL NERVE BLOCK; ONE (1) REPORT OF MILD PARESTHESIA AS EXPECTED; ONE (1) PLANTAR NERVE-RELATED EVENT; ONE (1) REPORT OF NUMBNESS ALONG THE TIBIAL POSTERIOR NERVE (POSSIBLE TARSAL TUNNEL SYNDROME) WITH ANTEROMEDIAL JOINT PAIN; ONE (1) GASTROCNEMIUS EQUINUS CONTRACTURE (40°); AND ONE (1) REPORT OF NEUROLOGICAL CHANGES IN BOTH LEGS. A TOTAL OF FOUR (4) REOPERATIONS WERE REPORTED. ALL EVENTS WERE ASSESSED AS NOT RELATED TO THE DEVICE."
        },
        {
          "mdr_text_key": "401923447",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION"
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "1370 CREEKSIDE BOULEVARD",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "800",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}