T-PAL, Technique Guide 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Synthes GmbH 에 의해 제조된 제품과 관련되어 있습니다.

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안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2014-08-01
  • 사례 출판 날짜
    2014-08-01
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: synthes t-pal, technique guide medical device manufacturer, synthes gmbh, has issued a medical device labeling update concerning its t-pal, technique guide [part no.: 036.001.088; updated revision ad; outdated revisions: aa, ab, ac]. the manufacturer updated the t-pal technique guide (pn 036.001.088) on page 19, 21 and 47 to clarify instrument handling of the t-pal applicator (pn 03.812.001 applicator outer shaft, pn 03.812.004 applicator knob). faulty handling of the t-pal applicator instrument potentially contributes to failure of the applicator inner shaft (pn 03.812.003) during insertion of implants or the non-detachable t-pal trial implants (pn 03.812.307-317 and 03.812.507-517). according to the manufacturer, if the inner shaft should break, the trial (or implant) spacer will no longer be secured in the 0o position. this rigid position is necessary for insertion; in the pivoting position, the assembly cannot be properly advanced into the disc space. furthermore, loss of rigidity during advancement of the trial (implant) into disc space could result in loss of tactile control by the surgeon. this failure is known to have resulted in a significant surgery delay and minor vascular injury. depending upon the stage of surgery, if the failure were to occur the potential harms in a worst case scenario could be: serious surgical delay; injuries to the spinal cord or cauda equina, meninges, and/or spinal nerve; damage to soft tissue; vascular damage. the manufacturer has not had any complaints of the above-mentioned events to date. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 01 aug 2014.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Synthes T-PAL, Technique Guide
  • Manufacturer

Manufacturer