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About this product

Division: International
Category: Cervical - Anterior Discectomy & Fusion (inc Revision & corpectomy)

UNIPLATE™ 2 Anterior Cervical Plate System was designed to simplify ACDF’s through the use of a narrow midline plate and streamlined surgical technique. This system features one point of midline fixation per level (one screw per vertebral body) for improved screw visualization, easier screw placement, and minimized lateral retraction, compared to conventional anterior cervical plate construct (two-screws per vertebral body).

The UNIPLATE 2 Anterior Cervical Plate System provides upgrades from the original UNIPLATE in that it offers bend-zones and has less material at the inferior and superior ends of the plate to reduce the risk of adjacent level impingement.

The UNIPLATE®2 Anterior Cervical Plate (ACP) is a featured brand in the CAM-LOC™ family of DePuy Synthes Spine ACP’s.

 

Intended Use

INDICATIONS

The UNIPLATE 2 Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in whom stability is desired following anterior cervical fusion for the indication s listed below. The intended levels from treatment range from C2 to T1.

Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumour, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, re-operation for filed fusion, or instability following surgery for the above indications.

These devices are not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

 

CONTRAINDICATIONS

  • Active systemic infection or an infection localized to the site of the proposed implantation.
  • Severe osteoporosis may prevent adequate fixation of screws and thus preclude the use of this or any other spinal instrumentation system.
  • Patients who have been shown to be safely and predictably treated without internal fixation.
  • Open wounds.
  • Relative contraindications include any entity or condition that totally precludes the possibility of fusion (e.g., cancer, kidney dialysis or osteopenia), obesity, certain degenerative diseases, and foreign body sensitivity.

 

WARNINGS

Correct placement of the device is essential to optimal performance. Use of the UNIPLATE Anterior Cervical Plate System should only be undertaken after the surgeon has become thoroughly knowledgeable about the spinal anatomy and biomechanics, has had experience with anterior approach spinal surgeries, and has had hands-on training in the use of the device.

  1. Correct selection of the implant is extremely important.
  2. Implants can break when subjected to the increased loading associated with delayed union or nonunion.
  3. Mixing metals can cause corrosion.
  4. In selecting patients for internal fixation devices, the following factors can be extremely important to the eventual success of the procedure, including: the patient’s occupation or activity; a condition of senility, mental illness, alcoholism, or drug abuse; certain degenerative diseases; foreign body sensitivity; smoking.
  5. If bony fusion does not occur within an expected period of time, the screws may break due to the high and sustained loading of these devices. This has been noted in patients with delayed, pseudoarthrosis or non-union and can result in the need to revise the device.

PRECAUTIONS

  1. Surgical implants must never be reused.
  2. Correct handling of the implant is extremely important.
  3. Titanium alloy components should never be bent sharply or reverse bent.
  4. If the devices are not removed after the completion of its intended use, any of the following complications may occur: corrosion with localized tissue reaction or pain; migration of implant position resulting in injury; risk of additional injury from postoperative trauma; bending, loosening, and/or breakage, which could make removal impractical or difficult; pain, discomfort, or abnormal sensations due to the presence of the device; possible increased risk of infection; and bone loss due to stress shielding. The surgeon should carefully weigh the risks versus the benefits when deciding when to remove the implant.
  5. Adequately instruct the patient. The patient must be made aware of the limitations of the implant, and instructed to limit and restrict physical activities.

Features & Benefits

 

  Features Benefits
Streamlined surgical technique
  • Aids in plate positioning and screw placement
  • Universal drill guide/plate holder allows awl/drill/tap and screw to pass through
  • Mid-line screw minimizes lateral retraction
  • Self-drilling and self-tapping screws
  • Pre-lordosed plate
Midline screw design  
  • Minimised lateral retraction compared to a four screw construct
  • 30 degree cone of angulation for optimum screw placement
Optimized plate design
  • Lowest profile plate that DePuy Synthes Spine offers at 2.3 mm, and narrowest plate offered at 10.5 mm, minimizes profile and protrusion on the oesophagus
  • Equivalent bending strength to traditional cervical plate
  • Cleats to limit plate slippage
  • Material has been minimized at the flattened portions of the plate to reduce the risk of adjacent level impingement
  • Optimised screw design coupled with posterior cleats on the plate provide biomechanical stability*
Third generation CAM-LOC mechanism Repeatable screw security assures screw is locked to avoid technique associated complications

 

V0811A
Please refer to the surgical technique guide or package inserts if included for a complete list of indications, contraindications, precautions and warnings. For further information on DePuy Synthes Products, please contact your local DePuy Synthes Representative .
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