BONGROS

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    BONGROS

     

    Composition:

    Highly pure, synthetic calcium hydroxyapatite (Ca10(PO4)6(OH)2).

    Presentation:

    Box contains 1 bottle granule 5 mL and 10 mL.

    Pharmacology:

    Bongros is a synthetic bone graft substitute that has a trabecular structure that resembles the interconnected 3-dimensional pore structure of human spongiosa bone which provides an osteocondutive effect for bone growth. This osteoconductive product provides the space for bony ingrowth and is combined with bone during the healing process.

    Indications:

    Bongros is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure, and to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis), and filling and/or augmenting intraoral/maxillofacial osseous defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

    Contraindications:

    - For indications which may be subjected to excessive impacts or stresses - Segmental defects - For fractures of the growth plate - When there is significant impairment proximal to the graft site - When there are metabolic or systemic disorders that affect bone or wound healing - When stabilization of the fracture is not possible - In cases where interaoperative soft tissue coverage is not planned or possible, and in infected sites.

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    Instruction for Use:

    These instructions are intended as guidelines for the use of Bongros granules and blocks as a part of established surgical techniques. They are not intended to replace or change standard procedures of treatment of defects involving bone grafting and internal fixation. Pre-operative Preparation : Radiographic evaluation of the defect site is essential to accurately assess the extent of the defect and to aid in the selection and placement of the Bongros and internal fixation devices. Surgical Procedure Notes : Bongros does not possess sufficient mechanical strength to support the reduction of a defect site prior to soft and hard tissue ingrowth. Therefore, anatomical reduction and rigidinternal fixation, in all planes, must be obtained independent of the Bongros using accepted internal fixation technique until ingrowth has occurred and the defect is healed. The site, size and geometry of a defect will determine the surgeon’s operative placement of the Bongros. Bongros granules can be used alone or mixed with premorselized autogenous or allogeneic bone graft. When using a bone graft/implant mixure, Bongros granules may be mixed with the bone graft after the bone has been reduced to small fragments.

    Warning and Precautions:

    - Do not use this device if the packaging is opened or damaged. - Bongros does not possess sufficient mechanical strength to support reduction of a defect site prior to soft and hard tissue ingrowth. - Standard internal fixation techniques for fracture fixation must be followed to obtain rigid stabilization in all planes. - External stabilization alone is not sufficient to achieve the rigidity necessary for bony ingrowth of the Bongros. - Bongros is intended for use by surgeons familiar with bone grafting and internal fixation techniques. - Complete postoperative wound closure is essential. - The Bongros must not be used to gain screw purchase or to stabilize screw placement. Screws used in conjunction with the Bongros and fixation devices must gain purchase into the host bone. - Bongros is radiopaque. Radiopacity may mask underlying pathological conditions. - Bongros should be stored at room temperature (<30°C).

    Adverse events:

    - Wound complications including hematoma, site drainage, bone fracture, infection, and other complications that are possible with any surgery - Fracture or extrusion of the Bongros, with or without generation of particulate debris - Deformity of the bone at the site - Incomplete, or lack of, osseous ingrowth into bone void, as is possible with any bone graft substitute - Reoperations to resolve postoperative infections and hardware complications may also require removal of the implant

    Drugs Interaction:

    -

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