Bonalive putty MIS

Bonalive^®
putty MIS

Bonalive^®putty MIS is a smart bone regeneration technology, providing stable positioning and controlled access in minimally invasive surgery.

The putty MIS offers healthcare professionals an easy and safe solution for filling the hardest-to-reach bone voids or gaps.

Delivered as a pre-filled cartridge, together with a dispenser delivery system, Bonalive® putty MIS is a sterile and ready-to-use paste. It requires no mixing, moistening or other preparation.

Easy to dispense and reaching a depth of up to 16 cm, the device provides controlled access, delivery and application for healthcare professionals. The exchangeable, pre-filled cartridges are only 8 mm thick in diameter and are used together with the dispenser.

Intended use
Bonalive® putty MIS is intended for use as a synthetic bone graft substitute for reconstruction and regeneration of bone.

Indications for use
Bonalive® putty MIS is indicated for filling, reconstruction, and/or fusion of bone voids and gaps of traumatic, pathological or surgical origin when autologous solutions are not applicable or sufficient. These bone defects of the skeletal system may be derived in orthopedic surgery, trauma surgery, neurosurgery, and cranio-maxillofacial surgery. Bonalive® putty MIS is indicated for use in spine surgery, in benign bone tumor surgery and in the treatment of osteomyelitis when pathological tissue has been surgically removed.

Intended user
Intended for use only by medically qualified professionals. The user must be familiar with bone grafting and fixation techniques.

Summary of Safety and Clinical Performance (SSCP)

Contraindications

Bonalive® putty MIS should not be applied:

In acutely or chronically infected tissues if the infected tissue is not adequately removed or not treated with appropriate therapy.
To replace structures that are subject to strong mechanical stress without proper stabilization.
In patients with acute traumatic injuries with open external wounds close to the defect, which are likely to become infected, if adequate infection management is not performed.
In patients that have received or are to receive chemotherapy or radiation therapy at or near the implant site.
In patients with known allergy to bioactive glass, PEG and/or glycerol.

Possible complications and side-effects

Inadequate bone formation, recurrent infection in relation to osteomyelitis, and local tissue irritation.
General post-surgical complications such as tenderness, pain, redness, edema, seroma, seroma leakage, hematoma, swelling, fluid collection in the operation area.
Surgical complications related to bone grafting procedures including wound infections, delayed union, loss of reduction, loss of bone graft, graft protrusion and/or dislodgement.