Events

Safety Alert for Osteosynthesis Material

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Changzhou Hengjie Medical Devices Co.Ltd..

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
    R1703-84
  • Event Number
    2011DM-0008305
  • Date
    2017-03-01
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=99
  • 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 it has detected the possibility of displacement of the screw that makes up the dhs system in the head of the femur, apparently due to a manufacturing defect in the sliding screw, observing that the marked limit of displacement is lower compared to others of the same measure, leading to to delays in the procedure opposing adverse events on the patient.

Device

Osteosynthesis Material
  • Model / Serial
  • Product Description
    Treatment of traumas and / or pathologies that compromise the appendicular skeleton. Treatment of fractures in the lower and upper limbs. Repair of bones and fractures in general, temporarily or definitively of the appendicular skeleton. Fixation of bone fragments and osteotomies. Orthopedic surgery. The surgical instrument is for exclusive use and is used to help alensamble / disassembly, implantation and removal of the implant.
  • Manufacturer
    Changzhou Hengjie Medical Devices Co.Ltd.

Manufacturer

Changzhou Hengjie Medical Devices Co.Ltd.