Events

NDI Disposable Reflective Marker Spheres 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 NDI Europe GmbH 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
    Field Safety Notice
  • 날짜
    2015-08-10
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • 데이터 추가 비고
  • 원인
    Ndl has determined there is a risk that disposable reflective marker spheres from these lots may separate at the mid—point where the two halves of the sphere are sealed together. such separation could occur either during installation onto reference arrays or surgical tools (i.E., when threading them onto posts) or at any time during a surgical procedure. this is due to inadequate curing of the adhesive that joins to two halves of the sphere. the root cause of this failure has been identified as a manufacturing issue in which a piece of the fabric material remained in the path of the uvnisible light used to cure the adhesive.

Device

NDI Disposable Reflective Marker Spheres
  • 모델명 / 제조번호(시리얼번호)
    C100111502 C101611501 C102811401 0103821501 C105151401 C107561301 C109011402 C100161401 C101611503 C102811402 C103881401 C105541401 C107761401 C109171301 C100611401 C101791401 C103091401 C104121401 C106061301 C108121301 0109251401 C100641501 C102061501 C103091402 C104361301 C106521401 C108191401 C109621401 C100641502 C102481501 C103221501 C104401401 C106861401 C108191402 C109621402 C101021501 C102581401 C103271401 C104401402 C106861402 C108471401 C110091401 C101351501 0102581402 C1032714021C104761401 C107371401 C108721401 C110411402 C101561401 C102801501 C103461501IC105071401 C107371402 C109011401 C110721401
  • Manufacturer
    NDI Europe GmbH

Manufacturer

NDI Europe GmbH