Events

Safety Alert for External system for cranial fixation during surgery

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Integra Lifesciences Corporation.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    I1501-37
  • Event Number
    2010DM-0006151
  • Date
    2015-01-21
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=187
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    ULTRA 360
  • Product Description
    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