Events

Custom Made Implant Systems with Minimally Invasive Grower (MIG) component 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Stryker Australia Pty Ltd 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
    RC-2018-RN-00083-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-01-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00083-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    In march 2007 the minimum invasive grower (mig) component with locking mechanism was utilised with custom made long bone replacement implants for limb salvage procedures of skeletally immature or juvenile patients, to prevent unintended changes in the length of the device. the instructions for use (ifu) for these types of devices did not clarify the function of the locking mechanism and the warnings related to the locking screw until october 2014, resulting in potential lack of awareness of the locking mechanism and its function during that time.The omission of this information in the ifu has been identified as a potential risk in risk management files for custom made devices, with the potential effects including; prolonged surgery, instability, pain, impaired function (gait) and early revision. limb length discrepancy was also identified as a potential effect based on complaints data review.
  • 조치
    Patients implanted with an affected lot number of the Custom Implants with MIG component should continue to be followed per the normal protocol established by his/her surgeon.

Device

Custom Made Implant Systems with Minimally Invasive Grower (MIG) component
  • 모델명 / 제조번호(시리얼번호)
    Custom Made Implant Systems with Minimally Invasive Grower (MIG) componentComponents implanted prior to October 2014Item Numbers: 13271, 14092, 14205, 15757, 16782, 17944These items are custom made to the patients ID and exempt from ARTG Numbers
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • 제조사 모회사 (2017)
    Stryker
  • Source
    DHTGA