Events

Osteosynthesis Material for Extremities 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
    R1607-291
  • 사례 연번
    2011DM-0007213
  • 날짜
    2016-07-22
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=131
  • 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 states that the batches affected in their yellow guide sheath could have been manufactured with a slightly larger diameter than the specified one, which could prevent the sheath from passing correctly through the brazodirectional tfna, leading to the occurrence of adverse events on patients.

Device

Osteosynthesis Material for Extremities
  • 모델명 / 제조번호(시리얼번호)
    GUIDE SLEEVE, reference 03.037.017, specific lots.
  • 제품 설명
    The osteosynthesis material for SYNTHES extremities are nonabsorbable implants designed to help immobilization, stable fixation and stabilization of bone fragments during the treatment of fractures, trauma, reconstruction and bone deformities, restoration of anatomical features and allowing an accurate approximation. There are different types of osteosynthesis implants corresponding to the bones of the extremities of the body, for example: femur, tibia, ulna, radius, humerus, hand, foot, etc. These osteosynthesis implants can be used or not in conjunction with the other osteosynthesis implants to immobilize the affected bone and fix in such a way to induce bone growth and scar healing. The intramedullary nails together with the debloqueo screws are used for the osteosynthesis of big bones like the femur, the tibia and the humerus. SYNTHES deosteosynthesis implants are classified into systems according to their dimensions and shapes that make them more suitable for different parts of the extremities of the body, their traumas and pathologies. It is noted that these implants can be combined with the original parts of the same system.
  • Manufacturer
    Synthes Gmbh

Manufacturer

Synthes Gmbh