Events

System for Articular Prostheses for Elbow rHead Radial Head 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Small Bone Innovations Internacional 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
    R1712-570
  • 사례 연번
    2010DM-0005229
  • 날짜
    2017-12-19
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=62
  • 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 as a result of a review of the data currently available from the referenced devices found that it was not conclusive to continue supporting the performance of the device, consequently decided to withdraw the product from global markets, health professionals who have implanted patients should continue monitoring according to the protocol of usual attention, since the described situation could lead to the occurrence of adverse events on patients.

Device

System for Articular Prostheses for Elbow rHead Radial Head
  • 모델명 / 제조번호(시리얼번호)
    RCNH2, RCNH3, RCNH4, RCNS1, RCNS160, RCNS2, RCNS260
  • 제품 설명
    To replace the head of the radio when there is degeneration due to arthritis or post-traumatic disability that presents pain, crepitus and decreased mobility in the radio-humeral bone or cubitoproximal radius, joint friction with articular destruction or subluxation visible on radiography and resistance to preservation of treatment for arthritis.
  • Manufacturer
    Small Bone Innovations Internacional

Manufacturer

Small Bone Innovations Internacional
  • 제조사 모회사 (2017)
    Stryker
  • Source
    NIDFSINVIMA