Events

Pangea Spine System, and others 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 Synthes 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
    2015-09-08
  • 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
    Technique guides for the systems mentioned above describe the pedicle awls as 4.0mm for use with screws (4.0mm — 7.0mm). these awls should be used with 5.0mm — 7.0mm screws. this field safety notice is being issued in order to communicate changes being made to technique guides and outer labels in order to clarify the intended use of these two awls within these systems. there has been no change to the design or manufacture of the pedicle awls.

Device

Pangea Spine System, and others
  • 모델명 / 제조번호(시리얼번호)
    Pangea Spine System, Technique Guide 036000.080 USS ll Polyaxial Spine System, Technique Guide 036000.216 MATRIX Spine System — Deformity, Technique Guide 036.001.180 MATRIX Spine System — Degenerative, Technique Guide 036.001.185 *Pangea Degenerative, Technique Guide 036.000.445 ’The Pangea Degenerative, Technique Guide (Technique Guide Number 036.000.445) has been added to this Field Safety Notice. Affected Labeling Description . Product Code Pedicle Awl 4.0mm wlCanevasit Handle 388.550 Pedicle Awl 4.0mm wlSiIicone Handle 388.656
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH