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About this product

Division: International
Category: Cervical Laminoplasty

The MOUNTAINEER® Laminoplasty System is a complete set of implants and instruments designed to allow for a systematic approach to laminoplasty procedures in the cervical spine. The system consists of three plate configurations to better accommodate patient anatomy and anatomical changes due to decompression procedures. Streamlined instrumentation provides an intuitive means to implantation of the laminoplasty plate.

The MOUNTAINEER Laminoplasty System offers a complete set of implants and instruments that allow for a systematic approach to posterior decompression of the cervical spine.

 

CHALLENGE:
Maintaining a secure grasp of the implant

SOLUTIONS:

– The dove-tail feature on the plate allows for a secure, flush fit attachment to the instruments.
– Notches on the allograft provide secure attachment points and tabs prevent the holder from migrating into the canal.
– A square tapered self-retaining screwdriver includes an outer sleeve for added security.

 

CHALLENGE:
Meeting each patient’s unique anatomical differences

 

SOLUTIONS:

– Three different plate options include Inline, Inline side-by-side and Hinge.

 

 

 

 

 

CHALLENGE:
Drilling and inserting screws on an unstable lamina

SOLUTIONS:

– A unique open ended plate allows for both a traditional and a Screw-First Technique, where the lamina screws can be inserted prior to creating the hinge.
– The lamina stabilizer grasps the lamina, while securely attaching to the plate, during screw insertion.

 

Intended Use

INDICATIONS
The MOUNTAINEER Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The MOUNTAINEER Laminoplasty System is used to hold or buttress the allograft or autograft material in place in order to prevent the allograft or autograft material from expulsion or impinging the spinal cord.

CONTRAINDICATIONS

Use of this system is contraindicated when there is active systemic infection, infection localized to the site of the proposed implantation, or when the patient has demonstrated allergy or foreign body sensitivity to any of the implant materials.

Severe osteoporosis may prevent adequate fixation and thus preclude the use of this or any other orthopaedic implant.
 

Conditions that may place excessive stresses on bone and implants, such as severe obesity or degenerative diseases, are relative contraindications. The decision whether to use these devices in such conditions must be made by the physician taking into account the risks versus the benefits to the patient.
 

Patients who have been shown to be safely and predictably treated without internal fixation. Use of these implants is relatively contraindicated in patients whose activity, mental capacity, mental illness, alcoholism, drug abuse, occupation, or lifestyle may interfere with their ability to follow postoperative restrictions and who may place undue stresses on the implant during bony healing and may be at a higher risk of implant failure.

WARNINGS, PRECAUTIONS AND ADVERSE EFFECTS CONCERNING SPINAL FIXATION IMPLANTS

Following are specific warnings, precautions and adverse effects that should be understood by the surgeon and explained to the patient. These warnings do not include all adverse effects that can occur with surgery in general, but are important considerations particular to devices such as the MOUNTAINEER Laminoplasty System implants. General surgical risks should be explained to the patient prior to surgery.

WARNINGS

  1. CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. The potential for a satisfactory laminoplasty procedure is increased by the selection of the proper size device. While proper selection can help minimize risks, the size and shape of human bones present limitations on the size, shape and strength of implants. Internal fixation devices cannot withstand activity levels equal to those placed on normal healthy bone. No implant can be expected to withstand indefinitely the unsupported stress of full weight bearing.
  2. IMPLANTS CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING ASSOCIATED WITH DELAYED UNION OR NONUNION. Internal fixation appliances are load-sharing devices that are used to obtain an alignment until normal healing occurs. If healing is delayed, or does fatigue. The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant. Notches, scratches or bending of the implant during the course of surgery may also contribute to early failure. Patients should be fully informed of the risks of implant failure.
  3. MIXING METALS CAN CAUSE CORROSION. There are many forms of corrosion damage and several of these occur on metals surgically implanted in humans. General or uniform corrosion is present on all implanted metals and alloys. The rate of corrosive attack on metal implant devices is usually very low due to the presence of passive surface films. Dissimilar metals in contact, such as titanium and stainless steel, accelerate the corrosion process of stainless steel and more rapid attack occurs. The presence of corrosion often accelerates fatigue fracture of implants. The amount of metal compounds released into the body system will also increase. Internal fixation devices which come into contact with other metal objects must be made from like or compatible metals. Avoid coupling of stainless steel with these implants.
  4. CLINICAL OUTCOMES MAY VARY. Patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without previous surgery.

 

PRECAUTIONS

  1. SURGICAL IMPLANTS MUST NEVER BE REUSED. An explanted implant should never be reimplanted. Even though a device appears undamaged, it may have small defects and internal stress patterns that may lead to early breakage. Reuse can compromise device performance and patient safety. Reuse of single use devices can also cause cross-contamination leading to patient infection.
  2. CORRECT HANDLING OF THE IMPLANT IS EXTREMELY IMPORTANT. Contouring of metal implants should be done only with proper equipment. The operating surgeon should avoid any notching, scratching or reverse bending of the devices when contouring. Alterations will produce defects in surface finish and internal stresses that may become the focal point for eventual breakage of the implant.
  3. REMOVAL OF SUPPLEMENTAL FIXATION AFTER HEALING. If the supplemental fixation is not removed following the completion of its intended use, any of the following complications may occur: (1)Corrosion, with localized tissue reaction or pain; (2) Migration of implant position resulting in injury; (3) Risk of additional injury from postoperative trauma; (4) Bending, loosening, and/or breakage, which could make removal impractical or difficult; (5) Pain, discomfort, or abnormal sensations due to the presence of the device; (6) Possible increased risk of infection; and (7) Bone loss due to stress shielding. The surgeon should carefully weigh the risks versus benefits when deciding whether to remove the implant. Implant removal should be followed by adequate postoperative management. If, for example, the patient is older and has a low activity level, the surgeon may choose not to remove the implant thus eliminating the risks involved with a second surgery.
  4. ADEQUATELY INSTRUCT THE PATIENT. Postoperative care and the patient’s ability and willingness to follow instructions are among the most important aspects of successful bone healing. The patient must be made aware of the limitations of the implants. The patient should be encouraged to ambulate to tolerance as soon as possible after surgery, and instructed to limit and restrict lifting and twisting motions and any type of sports participation until the bone fusion is complete. The patient should understand that implants are not as strong as normal healthy bone and could loosen, bend and/or break if excessive demands are placed on it, especially in the absence of complete bone healing. Implants displaced or damaged by improper activities may experience migration to the devices and damage to nerves or blood vessels.

Features & Benefits

 

  Features Benefits
Inline and Inline side-by-side plates
  • Large range of sizes ensures best anatomical fit
  • Inline and Inline side-by-side plates are available in lengths of 6, 8, 10, 12, 14, 16 and 18 mm
Hinge plates
  • Provides the ability to secure the lamina hinge
  • Plate sizes indicate the spacing between the ‘bends’ of the plate
  • Plate thickness: 1 mm
  • Plate offering:  6–18 mm (2mm increments)
  • Screw offering:  2.3 mm + 2.6 mm (4–12 mm lengths)
  • Plate color chart allows for easier identification by OR staff

    6 mm Blue
    8 mm Green
    10 mm Titanium
    12 mm Gold
    14 mm Magenta
    16 mm Light Blue
    18 mm Violet

 

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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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