External system for cranial fixation during surgery 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Integra Lifesciences Corporation 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
  • 사례 ID
    I1501-37
  • 사례 연번
    2010DM-0006151
  • 날짜
    2015-01-21
  • 사례 국가
  • 사례 출처
    INVIMA
  • 사례 출처 URL
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer states that there is a possibility of new failures in the locking mechanism of the handle in the base unit, leading to the occurrence of possible adverse events on patients.

Device

  • 모델명 / 제조번호(시리얼번호)
    ULTRA 360
  • 제품 설명
    The system for fixation of the skull, neck and / or spine during surgical procedures integrates, its instrumentation and accessories is indicated for: the fixation, stabilization and positioning of the skull, neck or column during surgery as well as for the retraction of tissue during surgical procedures in these regions of the body. It allows the head and neck to be held in rigid, particular positions when a rigid skeletal fixation is required or the taking of a diagnostic imaging in magnetic resonance or computed tomography is desired. Among the indications are cranial and spinal fixation during craniotomy and spinal surgeries due to brain tumors. Placement of derivations of hydrocephalus. Bleeding or mematomas of lesions (subdural oepidural hematoma). Brain aneurysms (weakness of blood vessels). Damage to the hard. Malformations of arteriovenous. Brain abscesses Cranial frame and repair of skull fractures. Spinal surgeries including: cervical disectomy and spinal fusion. Surgery of the neck (reconstructive debridement after damage by burn.) Repair of dislocation.
  • Manufacturer

Manufacturer