Events

Instrument Implant Hip System 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Stryker Leibinger Gmbh & Co. Kg || Stryker 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
    R1705-181
  • 사례 연번
    2008DM-0002104
  • 날짜
    2017-05-18
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=88
  • 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 it has detected that the screws were manufactured with the wrong material; titanium grade 4 (t014) was used instead of titanium grade 5 (t005), however, both materials are used in the manufacture of deosteosynthesis material and have a good biocompatibility behavior, however it could potentially lead to the presentation of adverse events on the patients or reinterventions.

Device

Instrument Implant Hip System
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    The material for osteosynthesis of small fragments of STRYKER is a set of plates, screws, washers and their instrumentation associated with other procedures of osteosynthesis of small bones such as: treatment and surgery of small bones, including those of the hand and wrist; internal fixation of the bones of the hand and wrist; internal fixation, reconstruction oartrodesis of small bones, including the forefoot, midfoot and hindfoot; for the treatment of: delescafoid fractures; fractures of the other carpal bones; pseudoarthrosis of the scaphoid; intercarpal arthrodesis; arthrodesis of the distal and proximal interphalangeal joints; fractures of the ulnar and radial epiphyses; osteotomies of transposition of the forefoot; for use in the internal fixation of fractures and distal radius reconstructions.
  • Manufacturer
    Stryker Leibinger Gmbh & Co. Kg || Stryker Gmbh

Manufacturer

Stryker Leibinger Gmbh & Co. Kg || Stryker Gmbh
  • 제조사 모회사 (2017)
    Stryker
  • Source
    NIDFSINVIMA