Interventional Spine—G3 Opticage Expandable Interbody Fusion Devices: Proximal End of the Device May Separate
December 14, 2016 | Risk Management News
ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Devices Alerts(HDA). For more information about HDA, contact us at firstname.lastname@example.org.
In a November 22, 2017 sic, Urgent Medical Device Recall letter submitted by an ECRI Institute member hospital, Interventional Spine states that the above devices may separate at the proximal end during implantation if the angle between the device and insertion instrument is too steep (>10 degrees), potentially preventing the device from expanding. Removal of a separated device with the insertion instrument will result in removal of only the proximal wedge portion of the device; the remainder of the device must be removed using other surgical instruments. Interventional Spine also states that this problem may lead to an extension of surgical time and suboptimal surgical results. Interventional Spine further states that it...