Product Overview
Our Malibu™ pedicle screw system takes a systems approach to posterior thoracolumbar and sacral fusion. Every design detail is optimized and complementary. This produces a posterior fixation solution that is both clinically versatile and easy to use.
Key Features:
• Integrated locking cap and set screw to reduce cross threading and prevent head splay
• Low-profile tulip to reduce run-on-rod
• Full complement of screws, hooks, and cross bars to address a multitude of patient pathologies
Indications:
The intended use of the Malibu, UCR, and NewPort Systems, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
The indications for use are as follows:
• Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
• Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System)
• Spondylolisthesis
• Trauma (i.e., fracture or dislocation)
• Spinal stenosis
• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Spinal tumor
• Pseudoarthrosis
• Failed previous fusion
The intended use and indications of the Malibu and UCR Systems, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows:
• Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
• Spondylolisthesis
• Trauma (i.e., fracture or dislocation)
• Spinal stenosis
• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudarthosis
• Failed previous fusion
(QF-10-01-06-ENGL-B)
Procedures:
Posterior Lumbar Fusion (https://www.seaspine.com/)
