Description
Depuy Spine Confidence Spinal Cement System Plus Kit 11cc
Part # 283910 Exp 11/15 Cement Exp 11/17, 10/15
Kit is incomplete. Following is what is included in the kit:
2 Boxes of Confidence High Viscosity Spinal Cement, Part # 183901001 Exp 11/17, 10/15
2 boxes Confidence Spinal Cement System Mini Mallet & Needle Holder Part # 283906300 Exp 11/15. 9/14
1 Box Confidence Spinal Cement System Hydraulic Pump Part # 283906100 Exp 11/15
Instruction Booklet
The CONFIDENCE SPINAL CEMENT SYSTEM combines unique highly viscous cement with a novel hydraulic delivery system. The radiopaque CONFIDENCE System reaches a dough-like phase immediately after the cement components have been mixed, without going through a liquid phase. The hydraulic delivery system enables a smooth introduction of the highly viscous cement into the vertebral body.
The CONFIDENCE System is part of a complete procedural solution for the personalized treatment of vertebral compression fractures. The a la carte offering allows for maximum economy, flexibility and precise surgical planning.
The CONFIDENCE SPINAL CEMENT SYSTEM is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).
The use of Confidence Spinal Cement is contraindicated in patients presenting with any of the following conditions:
- Use of CONFIDENCE Spinal Cement for prophylaxis (such as in metastatic or osteoporotic patients with no evidence of acute vertebral fracture)
- Coagulation disorders, or severe cardiopulmonary disease.
- Haemorrhagic diasthesis.
- Non-pathological, acute, traumatic fractures of the vertebra.
- Patient clearly improving on medical therapy.
- Spinal stenosis (> 20% by retropulsed fragments).
- Compromise of the vertebral body or walls of the pedicles.
- Compromise or instability of vertebral fractures due to posterior involvement.
- Anatomical damage of the vertebra that prevents safe access of the needle to the vertebral body.
- Vertebral body collapse to less than 1/3 (33%) original height.
- Vertebral plana (collapse >90%).
- Active or incompletely treated infection.
- Coagulopathy or inability to reverse anti- coagulant therapy (both during and approximately 24 hours post-procedure).
- Severe pulmonary insufficiency.
- Allergic reaction to any of the components of the CONFIDENCE Spinal Cement.
In Perfect sealed condition but past expiration date. Not for human use in the US.
Expiration dates have mostly to do with sterilization and not the integrity of the product. The manufacturers sterilize the products after they are packaged and it lasts so many years. The only products we caution customers about are ones that are absorbable or drug coated.
