Events

Safety Alert for KYPHON and KYPHON EXPRESS Directional Bone Void Filler

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

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
    2017-05-15
  • Event Date Posted
    2017-05-15
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170515b.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
    Medical device safety alert: medtronic kyphon and kyphon express directional bone void filler medical device manufacturer, medtronic, has issued a medical device safety alert concerning its kyphon and kyphon express directional bone void filler. [product number: f04c, all lot numbers affected]. the manufacturer has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut-out opening on the distal end of the instrument. using affected bone void filler may result in the injected cement being placed in a direction unintended by the surgeon. possible risks associated with this misalignment include cement extravasation into the spinal canal with a potential result of paralysis or nerve injury with risk of pulmonary embolism or cardiac arrest. the manufacturer has received two reports of this misalignment. to date there have been no associated patient injuries resulting from this issue. affected users are advised to locate and remove the impacted product from normal storage locations. they should discontinue use of the affected product and contact the manufacturer for recall and replacement. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 may 2017.

Device

KYPHON and KYPHON EXPRESS Directional Bone Void Filler
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic KYPHON and KYPHON EXPRESS Directional Bone Void Filler
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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