Products Legal Notices

Products Legal Notices

    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.

    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