Products Legal Notices

Products Legal Notices

    SpineJack®

  1. Medical Device, Class IIb, CE0459.
  2. For further information, please refer to the instructions for use.

  3. Countraindications
  4. The SpineJack® device is not indicated for any other application other than that for which it is designed.
    The list of counter-indications given below is not limited. Check the Instructions for Use of the cement to be used with the SpineJack® implant for more information.
    • Patient presenting a loss of vertebral height >50% compared to estimated prefracture height.
    • Patient presenting type B or C traumatic vertebral fractures according Magerl classification.
    • Sclerotic fracture or fracture not showing a pseudarthrosis.
    • Patient with a prior history of intolerance or of allergic reaction to titanium and/or one of the components of the PMMA cement.
    • Patient suffering from irreversible coagulopathy or undergoing anticoagulant treatment at the moment of surgery or at least 8 days prior to inclusion.
    • Active infection (systemic or in the target vertebra).
    • Patient suffering from a severe or uncontrolled systemic disease.
    • Patient presenting a pathological fracture with the presence of a mass within the spinal canal.
    • Patient presenting neurological damage caused by vertebral fracture.
    • Patient pregnant or likely to be so or breastfeeding.
    • Patient vertebral anatomy not compatible with the size of the implant or instrumentation.
    • Fracture geometry making the insertion of the implant impossible.

  5. Possible side effects
  6. The use of the SpineJack® system may directly or indirectly cause side effects and complications as presented in, but not limited to the list below. They are inherent to any percutaneous operation and linked to the injection of PMMA cement in the vertebral body:
    • Infections,
    • Haematomas,
    • Bleedings,
    • Allergies,
    • Thrombosis,
    • Adjacent vertebral fracture,
    • Rib fractures,
    • Intolerance to anesthesia,
    • Cement leaks,
    • Pulmonary embolism,
    • Fall in blood pressure / vagal reactions,
    • Cement intolerance,
    • Temporary aggravation of local pain,
    • Temporary radical pain,
    • Neurological complications (organic malfunctions, paraesthesia, radiculopathy,
    spinal canal or neural foraminal compression).
    In addition, refer to the side effects listed in the Instructions For Use of the PMMA cement used in combination with the SpineJack® implant.

    Cohesion® Bone Cement

  1. Medical Device, Class IIb, CE0086.
  2. For further information, please refer to the instructions for use.
    Product manufactured by Teknimed

  3. Countraindications
  4. – Patient clearly improving on conservative treatment
    – Cases of active or incompletely treated infection
    – Coagulation disorders, or with severe cardiopulmonary disease
    – Spinal stenosis (>20% by retropulsed fragments)
    – Neurological deficit
    – Unstable vertebral fractures
    – Prophylaxis in metastatic or osteoporotic patients with no evidence of acute fracture
    – In case of vertebroplasty procedure, non-pathological, acute traumatic fractures of the vertebra
    – Vertebral plana (collapse >90%)
    – Compromise of the walls of the pedicles
    – Sensitivity to any of the components of the cement
    – Do not use this cement for total hip or knee treatment
    – Do not use in children or women during pregnancy or lactation, as no evidence of safety exists for the use of this
    bone cement, inadequate information exists to determine if this bone cement might affect fertility in humans or have
    teratogenic potential or other adverse effects on a fetus.

  5. Possible side effects
  6. Vertebroplasty or kyphoplasty procedures may directly or indirectly cause the following complications:
    – Methylmethacrylate has been demonstrated to cause hypersensitivity in susceptible persons, which may result in an
    anaphylactic response
    – Infection
    – Cement leakages potentially symptomatic (ex: compressive)
    – Cardiac arrest
    – Cerebrovascular accident
    – Pulmonary embolism
    – Myocardial infarction
    – Sudden death
    – Hypertension
    – Hypotension
    – Short-term cardiac conduction disturbances
    – Pneumonia
    – Intercostal neuralgia
    – Adjacent fracture
    – Pneumothorax
    – Fracture of a pedicle.
    – Rib fracture
    – Spinal cord and nerves compression
    – Thrombophlebitis
    – Hemorrhage and hematoma
    – Fever
    – Hematuria
    – Dysuria
    – Bladder fistula
    – Transitory increase in pain due to heat released during polymerization

    Interface™ Bone Fixation Composite

  1. Medical Device, Class IIb, CE0086.
  2. For further information, please refer to the instructions for use.
    Product manufactured by Teknimed

  3. Countraindications
  4. The use of the Interface® Bone Fixation Composite osseous cement is contraindicated in patients having one of the following problems:
    – Cases of active, suspected or incompletely treated infection
    – Coagulation disorders, or severe cardiopulmonary disease
    – Spinal stenosis (>20% by retropulsed fragments)
    – Compromise of the vertebral fracture due to posterior involvement
    – Patient clearly improving on more conservative medical treatment
    – Prophylaxis in metastatic or osteoporotic patients with no evidence of acute fracture
    – Asymptomatic acute traumatic fractures of the vertebra
    – Vertebral plana (collapse>90%)
    – Compromise of the vertebral body or the walls of the pedicles
    – Hypersensitivity to one of the constituents of the product.
    – Due to insufficient data, the safety and efficacy of this cement has not been established with regard to pregnant women and children.
    – We do not recommend using these products on patients that do not suffer from a pathological condition, such as primary or secondary osteoporosis or a tumour. This could impair the ability of the patient to recover using conservative treatment methods.

  5. Possible side effects
  6. The cement can directly or indirectly cause the following complications: cardiac arrest, cerebrovascular accident, pulmonary embolism, myocardial infarction, sudden death, decrease in blood pressure, short-term cardiac conduction disorders.
    The vertebroplasty procedure may also cause the following adverse effects:
    – Pneumonia, intercostal neuralgia, pneumothorax, fracture of a pedicle;
    – Fracture of ribs in patients suffering from diffuse osteopenia, in particular during thoracic vertebroplasty procedures, due to the high pressure exerted downwards while the needle is being inserted;
    – Collapse of a vertebra adjacent to the injected vertebra due to an osteoporotic disease,
    – Leak of cement with compression of the spinal cord possibly resulting in paralysis or loss of sensitivity;
    – Leak of cement into the intervertebral disks;
    – Leak of cement into the vascular system
    – Leak of cement into soft tissues
    – Interactions with other agents: none known to date.

    Masterflow™

  1. Medical Device, Class IIa, CE0459.
  2. For further information, please refer to the instructions for use.

  3. Countraindications
  4. The Masterflow™ is not indicated for any application other
    than the one for which it was developed and validated.
    Also review the instructions for use of the Biomaterial in
    order to check the contraindications.

  5. Possible side effects
  6. Refer to the side effects listed in the Instructions For Use
    of the Biomaterial.