Events

ROTAIO Cervical Disc Prosthesis 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Emergo Asia Pacific Pty Ltd T/a Emergo Australia 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-2016-RN-01457-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-11-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01457-1
  • 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 the postoperative course patients reported a temporary or permanent development of noise. concerned were approx. 0.12 % of the disc prostheses. in some individual cases the doctors in charge decided to remove the implant. extensive analyses by the manufacturer, signus medizintechnik has not identified any indications as to the causes of the noise development as yet. examinations of implants removed and reference implants performed in that context showed that the prostheses were properly manufactured and fully functional with no structural defects or abnormal signs of wear and tear.
  • 조치
    The manufacturer is adding the possible side effect “temporary or permanent noise development” in the Instructions For Use (IFU).

Device

ROTAIO Cervical Disc Prosthesis

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia