{
  "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": "*",
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      "manufacturer_g1_state": "",
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      "manufacturer_contact_area_code": "",
      "date_added": "20200427",
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          "implant_flag": "",
          "date_removed_flag": "",
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          "generic_name": "HEX ABUTMENTS",
          "manufacturer_d_name": "BIOHORIZONS IMPLANT SYSTEMS",
          "manufacturer_d_address_1": "2300 RIVERCHASE CENTER",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "BIRMINGHAM, AL",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "",
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          "catalog_number": "TP3MU172",
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          "device_availability": "No answer provided",
          "device_report_product_code": "NHA",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
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          "udi_di": "",
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          "openfda": {
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            "fei_number": [
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            "device_name": "Abutment, Implant, Dental, Endosseous",
            "medical_specialty_description": "Dental",
            "regulation_number": "872.3630",
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          }
        }
      ],
      "product_problems": [
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      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250730",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20200427",
          "sequence_number_treatment": [
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        }
      ],
      "distributor_city": "",
      "initial_report_to_fda": "",
      "distributor_state": "",
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      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10002273",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "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",
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      "manufacturer_state": "",
      "distributor_address_2": "",
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      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "194364977",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THE PRODUCT THE THREE (3) MALFUNCTION EVENTS WERE NOT RETURNED FOR INVESTIGATION. THEREFORE, NO CONCLUSION MAY BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NON CONFORMANCES. THEREFORE, THE CONCLUSION MAY BE DRAWN THAT PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. WITH THE PRODUCT BEIGN MANUFACTURED TO SPECIFICATION, THE STRIPPED SCREW WOULD OCCUR OUTSIDE OF THE MANUFACTURERS PURVIEW."
        },
        {
          "mdr_text_key": "194364978",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INVOLVED ABUTMENT SCREWS BEING STRIPPED. NO PATIENT CONSEQUENCES WERE NOTED FOR THESE 6 OCCURENCES. NO INFORMATION REGARDING THE DEMOGRAPHICS OF THE PATIENTS WERE PROVIDED."
        }
      ],
      "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": ""
    }
  ]
}