ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease

Potential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery.

The sole distributor was notified by emailed letter of updates to the Surgical Technique Guide and IFU on 14 March 2023. The IFU has been updated to address a few small details including the direct listing of single use disposable components and the definition of single use being for one level only. The surgical technique guide has improved graphics, more thorough descriptions for some of the instrument assembly steps that your scrub techs may find useful and a statement regarding the appropriate use of the Flexible Curette Blade to prevent surgeons from using it in a way that may overstress the blade and cause a break. This information was shared with the surgeons through the sole distributor.