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 DePuySynthes 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 162 11 13 001
  • 사례 시작날짜
    2013-12-01
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=4855
  • 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
    Bending iron tips broke while surgeons were attempting to bend a spinal rod. the majority of complaints involve attempts to bend the warm-worked cobalt chrome (cocr) rods that are part of the matrix system. the failure mode of the tips on the returned field products consisted of a brittle fracture of the proximal tip (i.E. the tip closest to the surgeon). the root cause was determined to be material strength and geometry of the initial design.

Device

Surgical instruments , Bending Iron
  • 모델명 / 제조번호(시리얼번호)
    Part No : 03.632.040 , Bending Iron for Rods I2J 5.5 mm, left, for Coronal Plane & 03.632.041 Bending Iron for Rods 0 5.5 mm, right, for Coronal Plane. Lot No : T939750 , T939100 , T939750 , T939100 , T952744 , T939755 T939105 , T953987 …………………………………… FDA update code : Part number : ( 03.632.040 ) Lot Numbers : ( 03.632.040 T935338, T945062, T953982, T956310, T959990, T959995 ) Part number : ( 03.632.041 ) Lot Numbers : ( T935343, T939105, T945067, T952750, T956315, T960000, T960005 )
  • 제품 설명
    Surgical instruments
  • Manufacturer
    DePuySynthes

Manufacturer

DePuySynthes
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • 제조사 대표
    Johnson & Johnson Medical Meddile East
  • Source
    SFDA