Events

RIA System (Reamer / Irrigator / Aspirator) 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Synthes Gmbh 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
    R1611-489
  • 사례 연번
    2012DM-0008758
  • 날짜
    2016-10-21
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=118
  • 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 has determined that the wraps for the milling wands are delaminated, which hinders the opening of the sterile wrapping and could be experienced contact non-sterile surfaces contaminating them, a situation that would lead to possible adverse events on the patients.

Device

RIA System (Reamer / Irrigator / Aspirator)
  • 모델명 / 제조번호(시리얼번호)
    milling rod for SynReam 2.5 mm, length: 650 mm, sterile, reference 351.709S, lots || specific.
  • 제품 설명
    The RIA system (strawberry / irrigator / aspirator) is indicated for intramedullary milling and for the extraction of bone tissue, which cleans the medullary canal of bone marrow and debris. It is also used to clean the infected bone marrow canal, efficiently determine the size of the medullary canal for the acceptance of an implant or intramedullary prosthesis. RIA works by extracting autogenous bone tissue, finely morselized and bone marrow for any surgical intervention that requires a graft of bone tissue in order to facilitate fusion or fill bone defects. These interventions may be spinal fusion, joint arthrodesis, total joint replacement, fracture repair, absence of fracture consolidation, maxillofacial reconstruction, and tumor removal.
  • Manufacturer
    Synthes Gmbh

Manufacturer

Synthes Gmbh