baholzer - B-DYN

Page 2 / 48 Instructions for use Sterile spinal dynamic posterior stabilization device 1-DESCRIPTION The sterile spinal dynamic posterior stabilization device BDyn is intended to restore the stabilization of the non-cervical segment of the spine by preserving the anatomical lordosis and the deadening of the intervertebral joint. It is composed of the BDyn spinal shock absorber fixed on the vertebrae thanks to the dedicated polyaxial pedicle screws BDyn with plug and can be replaced according to the decision of the surgeon by a dedicated replacement rigid rod BDyn. 2-MATERIALS The B-DYN Device components are manufactured from medical grade titanium TA6V (ISO 5832-3; ASTM F 136), silicone, long-term implantable polyurethane. BDyn implant: Titanium alloy Ti6Al4V ELI (ISO 5832-3; ASTM F 136), Polydimethyl siloxane (PDMS) MED 4770 unrestricted Polycarbonate urethane (PCU) Bionate  II 80A BDyn ancillaries : Stainless steel, Titanium, Polypropylene No human or animal origin – Non resorbable. 3-INDICATIONS The sterile spinal dynamic posterior stabilization device BDyn is intended for posterior stabilization from thoracic vertebrae T10 to sacrum S1 with or without bone graft for the following indications: - Degenerative intervertebral disc disease and/or articular facets confirmed by further examinations - Spinal canal stenosis - Degenerative spondylolisthesis grade 1 - Segmental instability 4-PERFORMANCE The BDyn spinal shock absorber of the sterile spinal dynamic posterior stabilization device BDyn consists of a metallic cylindrical hollow part containing elastomer components made of silicone elastomers (polydimethyl siloxane (PDMS)) and long-term implantable polycarbonate urethane (PCU) which are bending out under the effect of a metallic piston rod connected with the vertebra of the treated segment by the polyaxial pedicle screws BDyn. The elastomer components assure the absorption of the mechanical loads applied on the intervertebral joint in compression, pulling, flexion-traction and lateral flexion. Some configurations enable fixation across several spinal segments. 5-CONTRAINDICATIONS - Active infectious process or significant risk of infection (immunocompromise) - Signs of local inflammation - Fever or leukocytosis - Morbid obesity - Pregnancy - Mental illness - Grossly distorted anatomy caused by congenital abnormalities - Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the presence of congenital abnormalities, elevation of the sedimentation rate unexplained by other diseases, elevation of the white blood count - Suspected or documented metal allergy or intolerance - Any case where the implant components selected for use would be too large or too small to achieve a successful result - Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality - Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance - Any patient unwilling to follow postoperative instructions - Any case not describe in the indications - Traumas (i.e. fracture or dislocation) - Abnormal curvatures (i.e. scoliosis and/or hyper lordosis) - Tumors. - Spondylolisthesis grade 2 and more - Pseudarthrosis and/or failed previous fusion - Severe bone resorption, osteomalacia, severe osteoporosis 6-UNDESIRABLE SIDE EFFECTS All of the possible adverse events associated with spinal surgery and without instrumentation are possible: - Infection - Pseudomeningocele, fistula, breach dura, persistent CSF leakage, meningitis - Loss of neurological function, sensorial and/or motor, including complete or incomplete paralysis, dysesthesias, hyperesthesia, anesthesia, paresthesia, appearance of radiculopathy, and/or the development or continuation of pain, numbness, neuroma, spasms, sensory loss, tingling sensation, and/or visual deficits - Cauda equina syndrome, neuropathy, transient or permanent neurological deficits, paraplegia, paraparesis, reflex deficits, irritation, arachnoïditis, and/or muscle loss - Urinary retention or loss of bladder control or other types of urological system compromise - Scar formation possibly causing by a neurological compromise or compression around nerves and/or pain - Fracture, microfracture, resorption, damage or penetration of any spinal bone (including the sacrum, pedicles, and/or vertebral body) and/or bone graft or bone graft harvest site at, above and/or below the level of surgery - Herniated nucleus pulposus, disc disruption or degeneration at, above, or below the level of surgery, canal adjacent stenosis - Non-union or pseudarthrosis, delayed union. Mal-union - Cessation of any potential growth of the operated portion of the spine - Loss of or increase in spinal mobility or function - Inability to perform the activities of daily living - Bone loss or decrease in bone density - Graft donor site complications including pain, fracture, or wound healing problems - Ileus, gastritis, bowel obstruction or loss of bowel control or other types of gastrointestinal system compromise - Hemorrhage, hematoma, occlusion, seroma, edema, hypertension, embolism, stroke, excessive bleeding, phlebitis, wound necrosis, wound dehiscence, damage to blood vessels, or other types of cardiovascular system compromise - Reproduction system compromise, sterility, sexual dysfunction - Development of respiratory problems, e.g. pulmonary embolism, atelectasis, bronchitis, pneumonia, etc - Change in mental status - Death