{
  "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": 185
    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "I",
      "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": "Injury",
      "report_number": "3005920706-2020-00005",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "N",
      "date_received": "20200611",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K172399",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "003",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
        "COMPANY REPRESENTATIVE",
        "HEALTH"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20200611",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "605576",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20200611",
          "brand_name": "MICROMATRIX",
          "generic_name": "MICROMATRIX",
          "manufacturer_d_name": "ACELL, INC.",
          "manufacturer_d_address_1": "6640 ELI WHITNEY DRIVE",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "COLUMBIA, MD",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "",
          "device_operator": "I",
          "model_number": "MM",
          "catalog_number": "MM",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "KGN",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "registration_number": [
              "3005920706"
            ],
            "fei_number": [
              "3005920706"
            ],
            "device_name": "Wound Dressing With Animal-Derived Material(S)",
            "medical_specialty_description": "Unknown",
            "regulation_number": "",
            "device_class": "U"
          }
        }
      ],
      "product_problems": [
        "Use of Device Problem",
        "Use of Device Problem"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250729",
      "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": "20200611",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Required Intervention"
          ],
          "patient_age": "0 YR",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Extraskeletal ossification",
            "Extraskeletal ossification"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20200526",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10146051",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20200526",
      "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": "Y",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "195266545",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THIS MDR IS BEING SUBMITTED DUE TO THE REPORTED ADVERSE EVENT AFTER INITIAL PLACEMENT OF THE ACELL DEVICE. A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE AS THE LOT AND SERIAL NUMBER WAS NOT PROVIDED BY THE PATIENT. WE ARE SUBMITTING THIS REPORT NOW, HOWEVER, ADDITIONAL INFORMATION HAS BEEN REQUESTED. AN UPDATE WILL BE PROVIDED UPON RECEIPT OF MORE INFORMATION."
        },
        {
          "mdr_text_key": "195266546",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "ON 5/26/2020, ACELL, INC. WAS NOTIFIED THAT MICROMATRIX WAS USED FOR THE SURGICAL REPAIR OF TRAUMATIC INJURY TO HANDS. PATIENT ALLEGED BONE OVERGROWTH DUE TO USE OF MICROMATRIX INTERNALLY NEXT TO EXPOSED BONE. THE USE OF MICROMATRIX INTERNALLY IS AN OFF-LABEL USE OF THE DEVICE."
        }
      ],
      "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": ""
    }
  ]
}