Events

Screw Module used with the ATLANTIS and Premier Anterior Cervical Plate System 의 안전성 경고

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

이것은 무엇인가요?

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
    2012-09-04
  • 사례 출판 날짜
    2012-09-04
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120904.html
  • 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: medtronic screw module used with the atlantis and premier anterior cervical plate system the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning the recall of the screw module ("screw caddy") used with the atlantis anterior cervical plate system and the premier anterior cervical plate system, (part numbers176-504, 176-503, and 1860503), manufactured by medtronic limited. medtronic has discovered that the measurement gauge located on the lower corner of the caddy may be out of specification, which could cause a screw to be measured improperly. an incorrect gauge could measure a screw to be approximately 1mm shorter than its actual length. no patient injuries have been reported to date. however, using an inappropriately long screw could cause irreversible neurologic injury if it penetrated the vertebral body. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 4 september 2012.

Device

Screw Module used with the ATLANTIS and Premier Anterior Cervical Plate System
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Medtronic Screw Module used with the ATLANTIS and Premier Anterior Cervical Plate System
  • Manufacturer
    Medtronic Limited

Manufacturer

Medtronic Limited
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH