Events

Alerta De Seguridad para External system for cranial fixation during surgery

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Integra Lifesciences Corporation.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    I1501-37
  • Número del evento
    2010DM-0006151
  • Fecha
    2015-01-21
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=187
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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

External system for cranial fixation during surgery
  • Modelo / Serial
    ULTRA 360
  • Descripción del producto
    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
    Integra Lifesciences Corporation

Manufacturer

Integra Lifesciences Corporation