Events

Patient Reference Frame ( Unclassified) 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Medtronic Navigation Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    21695
  • 사례 시작날짜
    2017-07-19
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Medtronic New Zealand Limited, Unit 16 Mezzanine Level, 5 Gloucester Park Road, Onehunga, AUCKLAND
  • 원인
    The manufacturer has become aware of instances where spine clamps have been damaged when forced open beyond their intended limits during use and will subsequently not open once attached to a patient's spinous process. when the spine clamp is forced open beyond its intended limits, a component (captive washer) may break off. the washer could then be inadvertently left behind in a patient's body if the breakage occurs during the procedure.
  • 조치
    Manufacturer to issue advice regarding use

Device

Patient Reference Frame ( Unclassified)
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: 9734715 Spinous Process Clamp, Tall, 9734716 Spinous Process Clamp, Short, 9734723 Double Spinous Process Clamp, Tall, 9734724 Double Spinous Process Clamp, Short, 9734715K Spinous Process Clamp, Tall, 9734716K Spinous Process Clamp, Short and 9734723K
  • Manufacturer
    Medtronic Navigation Inc

Manufacturer

Medtronic Navigation Inc
  • 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
    NZMMDSA