Events

Implant driver Profile EV 4.2, Long 에 대한 현장 안전성 서한

Inspectie Gezondheidszorg en Jeugd에 따르면, 해당 현장 안전성 서한 는 Netherlands 에서 DENTSPLY Implants Manufacturing GmbH 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 날짜
    2017-04-11
  • 사례 국가
    Netherlands
  • 사례 출처
    IGJ
  • 사례 출처 URL
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2017/04/11/field-safety-notice-dentsply-implants---implant-driver-profile-ev-4.2-long
  • 비고 / 경고
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • 데이터 추가 비고
  • 원인
    When using the faulty product, the lowest portion of the implant will be positioned in the wrong direction related to the jaw bone and instead of being aligned with the lowest portion of the crest it will be submerged below the highest part of the crest, which will not be in contact with the implant.

Device

Implant driver Profile EV 4.2, Long

Manufacturer

DENTSPLY Implants Manufacturing GmbH
  • 제조사 모회사 (2017)
    Dentsply Sirona Inc.
  • 제조사 의견
    Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
  • Source
    IGJ