Events

hydroxyapatite of bovine origin Endobon 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Biomet 3I Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    R1601-33
  • 사례 연번
    2009DM-0004199
  • 날짜
    2016-01-27
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=160
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer reports that in studies of cytotoxicity of the referenced product have shown a level 4 level for a study period of 36 months, however clarifies that for shorter periods (about 25 months approximately) the results have shown that there is no cytotoxicity, leading to potentially present adverse events on patients by exceeding the times determined as safe.

Device

hydroxyapatite of bovine origin Endobon
  • 모델명 / 제조번호(시리얼번호)
    ROX05, ROX10, ROX20, ROXLG20, ROXLG50 and ROXLG80, with useful life time between January 2016 and September || 2018
  • 제품 설명
    To permanently reconstruct uninfected bone defects. Filling of defects by resection of osseous tumors or bone cysts, bone defects after apicoectomy, filling of periodontal pockets in the lower maxilla, filling of "fresh" alveoli after extractions, osteotomy of the jaws.
  • Manufacturer
    Biomet 3I Inc.

Manufacturer

Biomet 3I Inc.
  • 제조사 모회사 (2017)
    Zimmer Biomet Holdings
  • 제조사 의견
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    NIDFSINVIMA