Events

Transpedicular Schanz Screw 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
    2013-06-12
  • 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
    Synthes received several complaints that the clamps could not be connected with the transpedicular schanz screw, because in some cases, the shaft of the screw is too thick.

Device

Transpedicular Schanz Screw
  • 모델명 / 제조번호(시리얼번호)
    296.630 Transped‘ ular Schanz Screw a 5.0 mm. shaft 2 5.0 mm, see separate list length 180/35 mm. Stainless Steel 296.690 Transpedlcular Schanz Screw 0 6.0 mm, shaft 9 5.0 mm, see separate list length 180/35 mm, Stainless Steel 296.780 Transped ular Schanz Screw 2/ 7.0 mm, shah 2 5.0 mm. see separate list length 180/35 mm. Stainless Steel 496.630 Transpedlcular Schanz Screw a 5.0 mm, shaft 6 5.0 mm, see separate list length ISO/35 mm, Titanium Alloy (TAN). gold 496.690 Transpedlcular Schanz Screw ¢ 6.0 mm, shaft 9 5.0 mm, see separate list length 180/35 mm. Titanium Alloy (TAM, gold 496.711 Transped ular Schanz Screw E 5.0 mm with dual core, length see separate list 180/35 mm. Titanium Alloy (TAN). violet 496.712 Transpedlcular Schanz Screw Bi 5.0 mm with dual core. length see separate list 185/40 mm. Titanium Alloy (TAN), violet 496.713 Transpedicular Schanz Screw a 5.0 mm with dual core, length see separate list 190/45 mm, Titanium Alloy (TAN), violet 496.714 Transpedicular Schanz Screw 2 5.0 mm with dual core, length see separate list 195/50 mm Titanium Alloy (TAN), violet 496.715 Transpedicuiar Schanz Screw 2/ 5.0 mm with dual core, length see separate list 200/55 mm, Titanium Alloy (TAN), violet 496.721 Transpedicular Schan: Screw 2 6.2 mm with dual core, length see separate list 180/35 mm Titanium Alloy (TAN), dark blue 496.722 Transpedloular Schanz Screw 0 6.2 mm with dual core. length see separate list 185/40 mm Titanium Alloy (T AN), dark blue . 777 496.723 Transpedicular Schanz Screw 9 6.2 mm with dual core. length see separate list 190/45 mm, Titanium Alloy (TAN), dark blue 495.724 Transpedicular Schanz Screw Z 62 mm with dual core, length see separate list 195/50 mm Titanium Alloy (TAN), dark blue 496.725 Transpedicular Schanz Screw z 6.2 mm with dual core. length see separate list 200/55 mm, Titanium Alloy (TAN), dark blue 496.780 Transpedicular Schanz Screw a 7.0 mm. shah a 5.0 mm, see separate list length 180/35 mm, Titanium Alloy (TAN)
  • Manufacturer
    Synthes Gmbh

Manufacturer

Synthes Gmbh