LIS, Dynesys Top-Loading System & Zimmer
The Dynesys Spinal System is indicated to provide spinal
alignment and dynamic re-stabilization in skeletally mature patients
up to 5 contiguous levels from L1 to S1 (Dynamic Neutralization
®). The system is intended to be used without bone graft
for the following indications.
Primary discopathy (spondylosis) and spondylarthrosis in combination with:
- · Discopathy hypomobile; degenerative retrolisthesis (up to
- · Discopathy hypermobile; degenerative
antelisthesis (up to grade I)
- · Degenerative
pseudo-spondylolisthesis (up to grade I)
- · Mono- or
multisegmental lumbar stenosis with or without olisthesis
When both the Dynesys Spinal System and the OPTIMA™
ZS Spinal System are used on adjacent levels, they must be used
with the Zimmer® DTO® Implant, rod-cord
combination implant, and the U & I Corporation OPTIMA ZS
Transition Screw. The intended use for each level is as specified for
LIS, Dynesys Top Loading System & Zimmer
Contraindications of the Dynesys Spinal System are similar
to other commercially available posterior spinal fixation systems.
Contraindications include but are not limited to the following:
- Scoliosis > 10° at the affected level(s)
- Degenerative spondylolisthesis or retrolisthesis > grade
- Isthmic spondylolisthesis at the segment(s) to be
stabilized dynamically (Dynesys)
- Treatment of the
thoracic and cervical spine
- Unilateral Dynesys
- Previous lumbar fusion attempt(s) at the
segment(s) to be stabilized dynamically (Dynesys)
- Previous facetectomy at the segment(s) to be stabilized
- Local Bone tumors
- Vertebral fractures
- Marked osteoporosis or osteomalacia
as evidenced by plain film radiographs or history of fractures
- Insufficient bone structures, impairing the anchorage of the
- Signs of infection
- Allergic reaction to
- Any patient unwilling to follow
The following adverse effects have been reported:
- Implants or implant parts can fracture, become loose or
undergo excessive wear, or their function may be impaired.
- Early or late infections.
- Bone fractures following
overloading, incorrect choice of the implant size or weakened bone
- Soft tissue and/or (temporary or permanent)
- Wound hematoma and slow wound-healing.
- Cardiovascular disorders.
- Muscle impairment.
- Limited mobility.
- Further degeneration.
- Adjacent-segment syndrome.
- Dural laceration,
pseudomeningocele, fistulisation, persistent loss of cerebrospinal
- Neurological disorders.
- Postoperative changes to the spinal curvature
and/ or loss of correction, alignment and/ or disc height.
- Hernia of the nucleus pulposus, ruptured disc or degeneration
in, above or below the operated segment.
resorption, damage or penetration of a spinal bone.
- Urinary retention or loss of bladder control or other types
of disorders of the urogenital system (e.g., retrograde