Events

Safety Alert for Implant Systems for Traumatology

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

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
    I1705-171
  • Event Number
    2013DM-0010034
  • Date
    2017-05-16
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=88
  • 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 the device is not completely cannulated and the guidewire will not be able to pass through it, this obstruction is related to a metal drill in the screw cannula that has not been eliminated during fabrication, this could lead to the occurrence adverse adverse events in surgical times.

Device

Implant Systems for Traumatology
  • Model / Serial
  • Product Description
    This device is used to stabilize open or unstable fractures and where soft tissue damage causes other fracture treatments such as IM bars, metal parts and other internal fixation means to be discarded. The indications for the fixation devices include: fixation of bone fractures, osteotomy, arthrodesis, correction of deformities, revision procedures when other treatments and devices, bone reconstruction procedures have failed.
  • Manufacturer
    Stryker Gmbh

Manufacturer

Stryker Gmbh
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    NIDFSINVIMA