Cousin Biotech INTRASPINE Gebrauchsanweisung Seite 2

Instructions for use en
®
IntraSPINE
DEVICE FOR THE INTER-SPINOUS SPACE WITH LAMINAR SUPPORT
SINGLE USE STERILE PRODUCT
DESCRIPTION
The IntraSPINE® prosthesis is an interlaminar medical device that comprises a dimethyl siloxane (silicon) wedge (available in several sizes) adapted
to the intervertebral space and a ligament in polyethylene terephtalate.
The wedge is covered with woven polyethylene terephtalate with an area covered by sheeting on the front face in the medullary zone.
Tension is applied to the ligament by a titanium loop (TA6V).
MATERIALS
IntraSPINE® prosthesis: Dimethyl siloxane, Polyethylene terephthalate, Titanium.
IntraSPINE® ancillaries and trial protheses: Stainless steel, Acetal copolymer, Dimethyl siloxane.
Non-human and non-animal origin – Non-resorbable.
INDICATIONS
The IntraSPINE® prosthesis is recommended in lombar surgery in the following cases:
- Arthropathic facet-syndrome
- Foraminal stenosis
- Degenerative discopathy
- Intervertebral ligament insufficiency
PERFORMANCE
The IntraSPINE® prosthesis is an elastic support device with a cushioning effect. Its interlaminar implantation enables it to be close to the centre of
rotation, thereby producing the cushioning effect and providing tension on the interspinous ligamentary structures due to the elasticity of the supra-
spinous wedge.
The principal function of the ligaments surrounding the upper and lower vertebrae in relation to the area receiving the prosthesis is to assist the
posterior ligament during flexion.
IntraSPINE® has been validated for a long term implantation in the human body.
CONTRAINDICATIONS
1) Do not use the prosthesis in the following cases:
- Allergy to one of the components
- Growing child
- Infected site
- Pregnant woman
2) Factors likely to compromise successful implantation:
- Severe osteoporosis
- Major deformations of the spinal column
- Local bone tumors
- Systemic or metabolic disorders
- Infectious diseases
- Obesity
- Drug addictions
- Intense physical activity, for example competitive sports or hard labor
UNDESIRABLE SECONDARY EFFECTS
1) Complications likely related to the device:
- Infection of the prosthesis, rupture of the ligament, loosening, fixed wing breakage, permanent elongation of the ligament, displacement of the
wedge, spondylolisthesis to the dynamically stabilized segment, persistent pain attributed to the dynamically stabilized level and required revision
surgery with interbody fusion at that level;
Spinous process fractures: intraoperative, post-operative or during device removal (removal due to infection) and can be associated with dislocation
of the implant;
Late reoperation due to absence of recovery;
In certain cases the medical instrument had to be removed and pedicle screw fusion had to be performed.
2) Complications unlikely related to the device but related to surgery or to the patient's conditions:
Dural tear, cerebral spinal fluid leak, hematoma, cardiovascular problems, deep venous thrombosis and embolism, acute myocardial infection,
superficial wound infection, short term unexplained visual disturbance, self-limiting pseudo-radicular pain in the other leg, late-onset lumbar spinal
canal hematoma formation.
POSTOPERATIVE PRECAUTIONS
The patient must be informed of the postoperative cares and of precautions.
The use of a brace could be necessary but is not mandatory. This decision is the surgeon one.
PRECAUTIONS FOR USE
Before usage, verify the integrity of the prosthesis, trial prostheses, ancillaries and packaging.
Do not use in the event of deterioration of the prosthesis and/or the labels, and/or the trial prostheses and/or the ancillaries and/or the packaging.
Do not use if the prosthesis has exceeded its use-by date.
Unpacking and manipulation of the implant must be carried out following asepsis standards in order to guarantee the sterility.
When opening the carton box, the surgeon has to make sure that the lot number, the model and the size of the prosthesis are equal to the data on
the label of the inner pouch. Otherwise the use of the prosthesis is strictly prohibited.
Prevent the prosthesis, the trial prostheses and ancillaries from coming in to contact with objects that may alter their surface.
Operation conditions: Temperature from +32°C up to 42°C. Implants should be resistant to biologic fluids and the discharge of body tissues, which
they contact during use. Therefore, the IntraSPINE® prosthesis has been validated for a long term implantation and, currently, Cousin Biotech has 7
years of feedback concerning these products.
The IntraSPINE® prosthesis, trial prostheses and ancillaries must only be used by a qualified surgeon who is trained in spinal surgery and to the
surgical technique of IntraSPINE®. The information contained in this notice is necessary but not sufficient to control the surgical technique.
The prescription of the device is decided on by the surgeon, the only person qualified to do so.
Each IntraSPINE® prosthesis, trial prostheses and ancillaries is part of a complete system and must only be used with the corresponding elements
from the original COUSIN BIOTECH system.
IntraSPINE® is made with soft materials, any contact with harder one may alter its mechanical behaviour and lifetime. It is mandatory to avoid
contact with other materials.
The implant has not been tested for safety and compatibility in the case of postoperative investigation using Magnetic Resonance Imaging
(MRI). However, the implant is made with Polyethylene terephtalate, Dimethyl siloxane and Titanium which are non-ferromagnetic in these
quantities according to literature. Consequently, the IntraSPINE® is compatible and safe with MRI.
Page 2 / 48