Codubix^® S Prosthesis for cranioplasty

PRODUCT CHARACTERISTICS

The Codubix® S prosthesis implanted in the bone defect in the cranial vault provides mechanical protection for the sensitive tissue of the brain, helps to balance the intracranial pressure and improves the cosmetic effect.

Codubix® S cranial bone grafts are knitted of:

• polypropylene yarn – featuring low specific weight and low melting temperature allowing for appropriate stiffness and hardness of the graft,
• polyester yarn – supplying adequate strength, both to bending and pressure, as well as surface spread.

High endurance, low specific weight, hydrophobicity contributing to the lack of absorption of liquids and physiological fluids, non-toxicity, chemical inactivity, high degree of healing in make Codubix® S grafts easy to identify with the natural cranial bone due to their physical properties. Codubix® S graft can be easily cut in order to shape it to fit the skull defect and it can be diagnosed without any artifacts. Pyrogen-free product. Product composition: 94% polypropylene and 6% polyester.

Note: It is possible to make a prosthesis adapted to the patient on the basis of a CT scan and adjust the shape of the prosthesis to a given defect in the skull bone.

DESTINATION AND INDICATIONS

Codubix® S knitted cranial bone grafts are intended for the reconstruction of skull cap defects.

The product is intended for use by a professional user – a specialist doctor, in patients with bone defects in the cranial vault.

CONTRAINDICATIONS

Medical device Codubix® S should not be used:

• in patients allergic to polypropylene and polyester,
• in children and where the physiological growth process limits its use.

SIDE EFFECTS

Implantation of all cranial grafts may cause postoperative complications depending on postoperative period. In early postoperative period the following may occur: infection, haematoma, oedema of the skin flap, formation of haemorrhagic or serous exudate, increase in body temperature, ischaemia of the skin flap. In late postoperative period the following may occur: pains in the scar, sensitivity disorders, collapsing of the prosthesis. All the above mentioned complications may cause longer recovery, repeated surgical intervention or even re-implantation in extreme cases. Any serious incident related to the device must be reported to the manufacturer and to the competent authority of the country where the user or patient resides.

PRECAUTIONS

1. The product is intended for use by qualified and properly trained medical personnel.
2. The cranial bone prosthesis should only be used in conditions where maintaining strict surgical asepsis is possible. In order to ensure it during the procedure, it is advisable to use special precautions (use of personal protection, sterilisation of instruments, high personal hygiene) and extra attention when preparing the site of direct intervention by the surgeon.
3. The product is intended for single use only. A reuse of the product may result in complications or serious damage to the health and life of the patient.
4. Codubix® S cranial prosthess offered for sale is sterile. It is not allowed to re-sterilise the Codubix® S cranial prosthesis.
5. Codubix® S grafts must not be implanted after the expiry date.
6. Shaping and cleaning of the graft should be performed under aseptic conditions.
7. Do not use when device is damaged, with structure defects or dirty.
8. The non-implanted product can be safely disposed of in accordance with the general rules of waste management. If the prosthesis is removed from the human body, the product should be treated as medical waste.

APPLICATION

The product is intended for use by qualified and properly trained personnel.

Prior to Codubix® S graft implantation the following must be specified:

• size of the defect,
• shape of the defect,
• curvature relevant to that of the skull. 

Final fitting and adjustment of the graft to the defect occurs intraoperatively (the implant can be cut). After it has been modelled, the graft needs to be carefully cleaned of the dust accumulated during the adjustment by rinsing the implant saline solution. 

The procedure of cleaning (time, volume of saline solution, etc.) may differ depending on the shape and size of the pre-shaped prosthesis. It must be ensured that all visible particles are carefully cleaned.

GUIDELINES

A critical part of the cranioplasty is to plan the skin incision line so that it goes at a minimum distance of 1 cm from the edge of the bone defect. When the skin flap has been peeled, the periosteum should be cut along the edge of the bone defect and relocated as much outside as necessary to determine the edge of the bone. Both the rim of the defect and Codubix® S graft should be modelled according to the  figures below. In order to fix Codubix® S graft, openings must be made 5 mm from the edge of the graft and the edge of the bone. (Fig.1). The openings are made with either a 2 mm dental drill or a trepan. 

The outer edge in Fig. 2 is bigger than the inner edge. The graft fills the defect as a wedge (Fig. 2).

Haemostasis should be performed prior to the graft fixation. Following the introduction of fixation sutures through the openings, the resulting knots should be placed inside the openings. Correct adjustment of the graft as well as good point of contact of the graft edge with edge of the bone and tightening of the sutures safeguards the immobility of the graft in relation to the bone. The existing periosteum is tied to the graft with an atraumatic suture, thus covering the point of contact with prosthesis. In extensive cranioplasty it is essential to fix a sucking drainage in the area beneath the skin flap for 24 hours following the surgical procedure.

Other methods of graft fixation are also acceptable. The decision regarding the fixation method is taken by the surgeon.

INFORMATION REGARDING THE STERILITY OF THE PRODUCT

The Codubix® S prosthesis is offered for sale as a product, sterilised with moist heat. The product cannot be re-sterilised. The product remains sterile until the expiry date, only in its original packaging, under appropriate storage conditions. If the outer and inner packaging is damaged, the medical device should be treated as non-sterile and cannot be used.

STORAGE

Codubix® S grafts should be stored:

• in dark rooms,
• at temperature range 15ºC – 35ºC,
• at humidity 25 – 65%,
• in conditions protecting against wetting, mechanical damage or contamination;
• in original unit packaging (cardboard box and direct packaging). Any mechanical damage to the packaging may expose the product to loss of sterility.

ADDITIONAL INFORMATION

A summary of the safety and clinical effectiveness of the device is available on tricomed.com website.

The unit packaging of the medical device contains an implant card with instructions on how to fill it in. A health care worker fills in the information specified in the implant card, and then provides it to the patient along with the discharge note from the hospital.