Events

Alerte De Sécurité sur External system for cranial fixation during surgery

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Integra Lifesciences Corporation.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    I1501-37
  • Numéro de l'événement
    2010DM-0006151
  • Date
    2015-01-21
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=187
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    ULTRA 360
  • Description du dispositif
    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