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Zimmer, Inc.

Universal ClampTM Spinal Fixation System

Product Description

The Universal Clamp spinal fusion device provides a stable interface between spinal anatomy and the rod through a pedicle-sparing band passage technique. The result is a spinal implant system that provides segmental stability, allows compression, distraction, derotation and translation while sparing the pedicles and reducing implant/bone contact stress.  It can work alone or alongside hooks, screws and wires, enabling surgeons to perform translation, reduction, distraction and compression in situ.  And it's backed by the training service and expertise you've come to expect from Zimmer.

Features

The Universal Clamp spinal implant system consists of three sterile parts furnished together:

  • One clamp
  • One woven polyester band
  • One locking screw

A great benefit of the system is its simplicity.  It provides a straightforward process for progressive posteromedial translation of the spine. It offers the user the adaptability of hooks and the simplicity of sublaminar instrumentation. Elegantly simple, Universal Clamp instrumentation allows surgeons to leverage off the strengths of this versatile spinal implant to correct a variety of spinal pathologies. The innovation of the design provides 10 times less contact stress than with a hook and 17 times less than with a wire.

ZS-OUS0050-03

Indications

The UNIVERSAL CLAMP is an osteosynthesis implant for the spinal column.

The implant is composed of a metallic clamp, a band, the distal portion of which includes a leader insert, and a locking screw that ensures the tightening onto the union rod.

The shape is adapted to the morphology of the levels treated, as well as to the recommendations given in the Surgical Technique. It is not recommended to use a Universal Clamp alone at the cephalad end of the construct in scoliosis surgery, especially in case of obesity, extreme kyphosis or muscular weakness. Autostable hooks, hooks or pedicle screws are recommended there.

Material and related standard for each part:

Version

Parts

Material

Standard

Ti version

One clamp (Ti)

Locking screw (blue)

Titanium alloy (Ti-6Al-4V)

ISO 5832-3

SST version

One clamp (SST)

Locking Screw (shiny)

Stainless steel (316L)

ISO 5832-1

All versions

One woven band and sutures

Polyester (Polyethyleneterephthalate – PET)

N/A

One band leader

Pure titanium (T40)

ISO 5832-2

Two buckles

Stainless Steel

NF-EN 10088-1

Indications

The Universal Clamp implant is a vertebral bone anchor that, used in an osteosynthesis construct, provides the stability necessary for solid spinal fusion and that permits reduction of spinal deformities and fractures.

The indications for use include the following applications:

  • Spinal trauma surgery, as an adjunct to spinal fusion,
  • Spinal reconstructive surgery, incorporated into constructs for the purpose of correcting spinal deformities such as scoliosis, hyperkyphosis, or spondylolisthesis,
  • Spinal degenerative surgery, as an adjunct to spinal fusion.

It is not recommended to use a Universal Clamp alone at the cephalad end of the construct in scoliosis surgery, especially in case of obesity, extreme kyphosis or muscular weakness. Autostable hooks, hooks or pedicle screws are recommended there.

Contraindications

Do not use Universal Clamp implants in the presence of any contraindication:

  • Local or general infections that may jeopardize the outcome of the operation,
  • Major local inflammation,
  • Pregnancy,
  • Immunodepressive diseases,
  • Bone metabolism disorders that potentially compromise the mechanical support expected from this type of implant,
  • Excessive physical activity,
  • These contraindications may be relative or absolute and must be taken into account during the decision process of the practitioner. This list is not exhaustive.

Precautions

Preoperative

  • Patient weight: Excess of weight is responsible for additional loading, which, in association with other factors, can lead to rupture of the implants.
  • Physical activity of the patient: Intense physical exercise during the period of consolidation increases the risk of mobilization, deformation or rupture of implants and failure to achieve fusion.
  • Mental handicaps: Risks are increased in patients who are incapable of observing surgeon recommendations. Physical handicaps require particular attention, even adaptation of the postoperative rehabilitation program.
  • Hypersensitivity to foreign bodies and/or to metallic ions: When hypersensitivity is suspected or known, the patient’s tolerance to the materials composing the implant should be tested before the operation.
  • Smoking has been shown to have negative effects on bone fusion, increasing the risk of non-union. Smokers must be informed of that.

Per-operative

  • The implants must be used with the instruments designed and supplied for this purpose according to the installation technique specific to each implant, the details of which are given in the Operative Technique supplied by Zimmer spine.
  • Bone quality: Osteoporosis or any other bone tissue disorder that may alter the mechanical qualities of the vertebrae must be taken into account when making the decision to use UNIVERSAL CLAMP implants.
  • It is imperative to adhere to the rule regarding the marks on the reduction instrument. If the user forces the cursor beyond the second mark, the corresponding tension in the band may crack the lamina and/or transverse process, depending on the strength of the patient’s bone.

Postoperative

The surgeon must warn the patient of the precautions to be taken following implantation of the device.

A rigid external orthosis is not usually required. However, the surgeon has to make this decision taking into account the specific characteristics of each patient (bone quality, treated and associated diseases, activity and weight of the patient, etc.).

Side Effects

  • Neurological complications, paralysis, soft tissue damage, pain due to the surgical intervention, implant migration,
  • Superficial or deep infection and inflammatory phenomena,
  • Allergic reaction to implant materials,
  • Reduction in bone density caused by altered distribution of mechanical stresses,
  • Neurological and/or dural lesions during the surgical procedure,
  • Presence of microparticles around the implants.

These side effects, of which the list is not exhaustive, may require further surgery.