(Best results will be obtained by following these directions.)
The Device is packaged with plunger inserted in the cannula, ready to be inserted into the prepared, distracted disk space. Inspect the package prior to use.
Remove from the sterile package, inspect and handle the Device components in accordance with aseptic techniques and per orthopedic surgical practice.
Distract the disk space with wedge dilators per the cage manufacturers protocol. Maintain the distraction with provisional contralateral pedicle screw fixation. Attention: A minimum of 8mm of distraction is necessary to safely use the device.
Try a sample of the graft material with the KG® 1 to ensure flowability.
Insert the plunger/stylet into the empty cannula without the funnel and insert the complex into the disk space. Remove the stylet and attach the funnel.
Apply the graft material with thumb and finger pressure into the cannula. Push the plunger all the way down to expel the graft material. If the disk space does not vent the air out of the disk, remove the cannula and increase the size of the annulotomy. Apply 2-3 ml of graft with each pass of the plunger. You will feel resistance of flow when the disk space has filled up. Tapping on the plunger will expel residual graft, avoid using a mallet.
Remove the stylet and funnel and directly observe the area around the annulotomy/ cannula interface to confirm that graft material has not overflowed.
Remove cannula and insert cage per the manufacturer recommendations
Discard the device with other disposables after single patient use.
Continue with the surgical procedure and instrumentation where indicated.
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Kleiner, J.B., Kleiner, H.M., Grimberg, E.J., Correlation of Diskectomy Volume and BG Insertion, Society for Minimally Invasive Spine Surgery, Miami, Florida, September 21-23, 2012.
Kleiner, J.B., Kleiner, H.M. and Grimberg, E.J., Jr. Relationship Between Diskectomy Volume and Bone Graft Insertion Volume in TLIF Procedures. The 9th Annual Evidence and Technology Spine Summit, Park City, UT, February 28—March 2, 2013.
Kleiner, J.B., Kleiner, H.M. and Grimberg, E.J., Jr. Relationship Between Diskectomy Volume and Bone Graft Insertion Volume in TLIF Procedures. ISASS Annual Meeting, Vancouver, BC, April 3—5, 2013.
Kleiner, J.B., and Grimberg, E.J., Jr. Bone Graft Delivery to the Prepared Disk Space in MIS T-LIF and L-LIF Procedures: A problem Solved. ISASS Annual Meeting, Vancouver, BC, April 3-5, 2013.
Kleiner, J.B., Kleiner, H.M., Grimberg, E.J., Jr. and Throlson, S.J. Bone Graft Delivery to the L4-5 and L5-S1 Disk Space: A Quantitative and Qualitative Analysis. Minimally Invasive Neurosurgical Society (MINS) Annual Meeting. August 9—11, 2013, William Beaumont Hospital, Detroit, MI.
Kleiner, J.B., Kleiner, H.M., Grimberg, E.J., Jr. and Throlson, S.J. Critical Analysis of T-LIF Diskectomy and Fusion. The Annual Meeting of the American College of Spine Surgery, Las Vegas, NV, April 24-26, 2014. Best Paper Award.
Kleiner, J.B., Kleiner, H.M., Grimberg, E.J., Jr. and Throlson, S.J. A Critical Analysis of Diskectomy Volume and Bone Graft Delivery During T-LIF Surgery. World Congress of Minimally Invasive Spine Surgery IV, Paris, France, June 11-14, 2014.
Kleiner, J.B. A Critical Analysis of Bone Graft Delivery to the L4-5 and L5-S1 Disk Space During T-Lif Fusion. 13th Annual John McCullough Memorial Conference, Breckenridge, CO, February 26-28, 2015.