Events

Safety Alert for ATLANTIS™ / PREMIER® / VERTEX® Adjustable Drill Stop

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Medtronic Limited.

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
  • Date
    2012-03-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120314c.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Field safety notice: medtronic atlantis™ / premier® / vertex® adjustable drill stop the medicines and healthcare products regulatory agencies (mhra), united kingdom posted a field safety notice concerning atlantis™ / premier® / vertex® 876-460, 6860460 and 6905712 manufactured by medtronic limited. medtronic is recalling all lots of an adjustable drill stop which may be used for spinal surgery because there is a possibility that the pre-set drill depth established by the adjustable drill stop could inadvertently change during use with powered instrumentation. no patient injuries have been reported to date. however, using an 876-460, 6860460 or 6905712 adjustable drill stop could cause irreversible neurologic injury if it penetrated through the posterior cortex of the vertebral body. if this occurred, it would necessitate immediate surgical intervention repairing any damage to the surrounding vasculature/neurologic structures; the injuries could include, but are not limited to, vascular penetration, in the cervico-thoracic region and/or spinal cord damage. complications of this type of injury may lead to irreversible impairment and/or death. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the product, please contact your supplier for necessary actions.

Device

ATLANTIS™ / PREMIER® / VERTEX® Adjustable Drill Stop
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic ATLANTIS™ / PREMIERR / VERTEX® Adjustable Drill Stop
  • Manufacturer
    Medtronic Limited

Manufacturer

Medtronic Limited
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH