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