The M8 Cannulated Multi Axial Pedicle Screws may be removed by applying the M8 Multi Axial screwdriver or extender reattachment driver from the SEXTANT instrumentation set to the screw and turn- ing counter-clockwise until the screw is removed from the pedicle.

How often do pedicle screws break?

Pedicle screw breakage is reported to occur in 1-11.2% of inserted screws and in 0.4-24.5% of patients3, 5. This implant failure can be a result of pseudarthrosis and can lead to pedicle screw or rod breakage5.

What is a fenestrated screw?

The CD HORIZON™ Fenestrated Screw Set consists of a variety of cannulated screws. This cement is used to augment screw fixation into the pedicle in patients with advanced stage tumors with compromised bone quality.

What are the symptoms of a failed lumbar fusion?

In addition to chronic back pain, other symptoms of failed back surgery include neurological symptoms (eg, numbness, weakness, tingling sensations), leg pain, and radicular pain (pain that spreads from one area of the body to another, such as from your neck down to your arm).

What does lucency around the screws mean?

Lucency around a screw was defined as a 1mm or greater radiolucent halo surrounding a pedicle screw. All radiographic assessments were made by the senior author.

Where do screws go in spinal fusion?

Pedicle screws are placed above and below the vertebrae that were fused. A rod is used to connect the screws which prevents movement and allows the bone graft to heal. After the fusion is completely healed, the screws and rods can be removed.

What are the screws used in pediatric cases made of?

All screws used in pediatric cases are only cleared for use via a posterior approach. All of the components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, and medical grade cobalt-chromium-molybdenum alloy.

What screws are not allowed in the Cd horizon™ spinal system?

Certain components within the CD Horizon™ Spinal System are specifically excluded for use in pediatric patients. These include PEEK rods, Shape Memory Alloy Staples, Spire™ plates, and Dynalok™ bolts. All screws used in pediatric cases are only cleared for use via a posterior approach.

What level of lumbosacral spine is this device intended for?

This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.