Events

translation missing: ko.activerecord.attributes.event.titles.recall_field_safety_notice

Saudi Food & Drug Authority에 따르면, 해당 translation missing: ko.activerecord.attributes.event.types.recall_field_safety_notice 는 Saudi Arabia 에서 Stryker Osteosynthesis Intramedullary Solutions 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall / Field Safety Notice
  • 사례 ID
    mdprc 006 04 13 000
  • 사례 시작날짜
    2013-04-02
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=3372
  • 비고 / 경고
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • 데이터 추가 비고
    Report Source: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    Stryker received a report indicating that the scale of the axsos calibrated drill bit ø4.3mmx263mm, flat, is incorrect. the scale is used to indicate the correct screw length after the drilling step during surgery, which allows the screw length to be read on the scale and at the end of the drill guide. the incorrect scale could result in the surgeon selecting a screw that is 10mm longer than intended.

Device

Non-sterile fluted surgical drill, AxSOS Calibrated Drill Bit ø4.3mmx263mm

Manufacturer

Stryker Osteosynthesis Intramedullary Solutions
  • 제조사 모회사 (2017)
    Stryker
  • 제조사 대표
    Al-Faisaliah Medical System, Riyadh, (01) 2119948
  • Source
    SFDA