Events

Safety Alert for High Viscosity Spinal Cement CONFIDENCE

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Teknimed S.A.S. || Depuy Spine, Inc. || Medos International Sarl.

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
    R1712-574
  • Event Number
    2009DM-0004623
  • Date
    2017-12-29
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=61
  • 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 reports that it has detected that due to a manufacturing error, the referenced devices may contain variable amounts of contrast medium below the specification, causing the impairment of visibility under x-rays, resulting in possible intraoperative and postoperative damage, the health professionals that they have implanted patients should continue the follow-up according to the usual care protocol, since the situation described could lead to possible adverse events on the patients.

Device

High Viscosity Spinal Cement CONFIDENCE
  • Model / Serial
    283910000, 283913000, lots 129385 129386 133829 133831 133825
  • Product Description
    Indicated for the percutaneous application of CONFIDENCE spinal cements, used for the fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures can be caused by osteoporosis, benign lesions (hemangiomas) and malignant lesions (metastatic cancer, myeloma ).
  • Manufacturer
    Teknimed S.A.S. || Depuy Spine, Inc. || Medos International Sarl

Manufacturer

Teknimed S.A.S. || Depuy Spine, Inc. || Medos International Sarl
  • Source
    NIDFSINVIMA