Osteopore Bioresorbable Bone Scaffold

Indications: The Osteomesh^®/Osteoplug^®/Osteoplug^®-C/ Osteostrip is a Bone Void Filler. It is intended for use in the repair of neurosurgical burr holes, craniotomy cuts and other cranial defects. It is also for use in the augmentation or restoration of bony contour in the craniofacial skeleton. The shape of the device conforms to the defect, thus maximizing direct contact with viable host bone. The device is made of polycaprolactone which will degrade and resorb fully in vivo by hydrolysis into which it is then metabolized by the body, over a period of 18-24 months. This device does not contain radioactive substances and is safe for use with MRI.

Contraindications: Do not use in patients with conditions including: latent or active infections, systemic disorders which will hinder wound healing, or with insufficient quantity or quality of bone stock. Do not use in contaminated surgical areas. Do not use in patients with septic reactions. Not indicated for load bearing anatomical sites. Do not use in areas exposed to outside environment.

Warnings: Do not use if a package has been opened or damaged. For single use only. Additional sterilization may alter device characteristics, e.g. advanced resorption. Do not use if there is a loss of sterility. Do not resterilize. Do not expose to direct sunlight. Excessive bending (>90 degree) of the device will cause scaffold rods to break down, thus rendering it unsuitable for implantation. Disposal of devices that have been implanted but then removed from the patient are deemed contaminated and shall be disposed appropriately as biohazard waste as part of routine hospital practice.

Precautions: Patient must be warned that excessive stress or load on surgical site post-implantation will cause it to loosen or fracture. Patient must be educated of the surgical risk and possible postoperative effects if due care and instructions are not followed. External exposure should be avoided. (Osteomesh^® only) The safety and effectiveness of adding any substances to the device is not known. These may change the setting time, strength, and reaction rate. The safety and effectiveness of the material when used adjacent to non-viable bone is not known. If there is a need to re-operate in the area of the implant, the device should be removed. The effect of the device on patients with sinus obliteration is not known. (Osteomesh^® only)

Potential Adverse Effects: Infections both deep and superficial. Bending, loosening, rubbing and migration of the device can occur as a result of excessive activity, trauma or load bearing. (Osteomesh^® only) Allergies and other reactions to scaffold materials. Neurovascular injuries can occur in course of surgery. Fracture and migration can occur due to excessive trauma or load bearing. Other possible adverse reactions with the mesh are those typically associated with any implantable prosthesis, including, but not limited to residual diplopia, persistent enophthalmos, ectropion, scleral show, implant extrusion and infraorbital hypesthesia. (Osteomesh^® only)