EXPEDIUM® 4.5 System

Division: Spine
Category: Deformity

A common sentiment among spine surgeons engaged in the treatment of pediatric patients and small stature patients is that larger deformities in smaller anatomies are one of the most challenging issues in spinal surgery. Concerns over implant profile and implant selection, along with the ability to choose instrumentation based on patient size and pathology are fairly common when treating this patient group.

To address these concerns, DePuy Synthes Spine has developed a complete rod-hook-screw system specifically designed for these smaller anatomies: the EXPEDIUM® 4.5 System.

The EXPEDIUM 4.5 System exhibits the lowest profile in our Thoracolumbar Portfolio, making it a useful option for cases in which the surgeon is challenged with implant protrusion and cosmetic issues. In addition, the system combines a variety of screw and hook designs (e.g., polyaxial, uniplanar, etc) and rod materials (i.e., Ti, SS and CoCr Alloy) to offer flexibility for the treatment of even the most complex cases.

Indications for Use

INDICATIONS

The EXPEDIUM Spine System and VIPER Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM Spine System and VIPER Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a percutaneous, posterior approach with MIS Instrumentation, the VIPER Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM and VIPER/VIPER2 Systems are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM and VIPER/VIPER2 systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

CONTRAINDICATIONS

Disease conditions that have been shown to be safely and predictably managed without the use of internal fixation devices are relative contraindications to the use of these devices.

Active systemic infection or infection localized to the site of the proposed implantation are contraindications to implantation.

Severe osteoporosis is a relative contraindication because it may prevent adequate fixation of spinal anchors and thus preclude the use of this or any other spinal instrumentation system.

Any entity or condition that totally precludes the possibility of fusion, i.e., cancer, kidney dialysis, or osteopenia is a relative contraindication. Other relative contraindications include obesity, certain degenerative diseases, and foreign body sensitivity. In addition, the patient's occupation or activity level or mental capacity may be relative contraindications to this surgery. Specifically, patients who because of their occupation or lifestyle, or because of conditions such as mental illness, alcoholism, or drug abuse, may place undue stresses on the implant during bony healing and may be at higher risk for implant failure.

WARNING: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.

PRECAUTION: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.

The surgeon must be thoroughly knowledgeable not only in the medical and surgical aspects of the implant, but must also be aware of the mechanical and metallurgical limitations of metallic surgical implants. Postoperative care is extremely important. The patient must be instructed in the limitations of the metallic implant and be warned regarding weight bearing and body stresses on the appliance prior to firm bone healing. The patient should be warned that noncompliance with postoperative instructions could lead to failure of the implant and possible need thereafter for additional surgery to remove the device.

WARNING: This product has labeling limitations. See package insert for additional warnings, precautions and possible adverse effects.

CAUTION: USA law restricts this device to sale by or on the order of physician.

Features & Benefits

  Features Benefits

EXPEDIUM 4.5 System polyaxial screw | DePuy Synthes Companies

EXPEDIUM 4.5 Polyaxial Screw has an 11% reduction in height from the already low profile EXPEDIUM 5.5 Screw.

Low implant profile Decreases soft tissue disruption

In-Line Technology (e.g., Top loading polyaxial, monoaxial, uniplanar, and reduction screws)

 

Offset Technology (bolts and slotted connectors)

 

Complete line of hooks

 

Ti, SS and CoCr Alloy rods

Appropriate implant option is available for each patient’s anatomy and pathology, and the surgeon’s preferred correction technique
Instruments specifically designed for smaller anatomies Instruments provide the precision & tactile feel that is critical for procedures in smaller anatomies

Common implant features with other systems in the EXPEDIUM System Portfolio:

 

Square Thread set screw

 

TOP NOTCH® Feature

 

Reduction Tools

Secure closure mechanism and implant/instrument interface (via the TOP NOTCH feature) allow for efficient and controlled correction maneuvers

Interconnectivity with other EXPEDIUM System Products Offers the ability to create hybrid constructs and simplifies revision cases

 

DSUS/SPN/0714/0391(1) 05/2016

All medical devices have associated risks. Please refer to the package insert and other labeling for a complete list of indications, contraindications, precautions and warnings. For further information on DePuy Synthes Products, please contact your local DePuy Synthes Representative.