Bongros is made of highly pure, synthetic Hydroxyapatite (Ca10(PO4)6(OH)2). This product is supplied sterile in granules and preformed shapes for single patient use. Bongros has trabecular structure that resembles the 3-dimensional interconnected pore structure of human cancellous bone. When Bongros is placed in direct contact with viable bone, the reticulated spaces in the implant are infiltrated with hard tissue. Bone formation occurs in apposition to the Bongros surface and within the interstices of the implant skeleton.
Bongros is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Bongros is indicated 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. This osteoconductive product provides the space for bony ingrowth and is combined with bone during the healing process.
This guide is used as a guideline for using Bongros granules and block as a chart of operating techniques. It is not intended to replace or change standard procedures for handling damage involving bone grafting and internal fixation.
Preoperative preparation: Radiographic monitoring of an area that has significant damage in order to accurately assess the extent of damage and to assist in the selection and placement of Bongros and internal fixation devices.
Caution on surgical procedures: Bongros does not have sufficient mechanical strength to support a function impairment of the damaged parts before soft & hard tissue ingrowth. Therefore, strong anatomical reduction and internal fixation, in all planes, must be carried out regardless of the use of Bongros using adequate internal fixation techniques until bone growth and healing of the damaged part occur. The site, size and geometry of the damage parts will determine the placement of Bongros by the surgeon.
Bongros granules can be used alone or mixed with premorselized autogenous or allogeneic bone graft. If using a mixture of bone graft/implant, Bongros granules can be mixed with a bonegraft after the bone has been crushed into small fragments.
Bongros is contraindicated for indications which may be subjected to excessive impacts or stresses; for 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 intraoperative soft tissue coverage is not planned or possible, and in infected sites. Conditions representing relative contraindications include: Severe vascular or neurological disease; Uncontrolled diabetes; Severe degenerative bone disease; Pregnancy; Uncooperative patients who will not or cannot follow postoperative instructions, including individuals who abuse drugs and/or alcohol; Hypercalcemia; Renal compromised patients; Patients with a history of or acting Pott's disease.
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.
No attempt should be made to alter the size of the Bongros granules: For best results, the Bongros blocks should fill the defect and contact viable bone as much as possible. If intraoperative shaping is requiredto maximize bony contact, the implant can be carved to optimum shapes by wetting the implant with sterile normal saline and carving with #10 or #15 scalpel blade. The implant can also be shaped with bone cutting forceps or rongeurs. After final shaping, the implant should be thoroughly rinsed in sterile normal saline or sterile distilled water to remove any particulate matter from the surface pores. After implantation of the Bongros block,residual local bone or Bongros granules of not less than 1mm in diameter may be used to re-establish continuity around the implant. Fixation must ensure reduced loading of the Bongros site and must be sufficient to prevent collapse and deformity secondary to axial or functional loading. Fixation with plates and/or screws is recommended. Wirescan be used as adjuncts to rigid fixators. Bongros must not be used to repair defects where complete soft tissue coverage cannot be achieved.
Post-operative Care: Post-operative patient management should follow the same course of therapy as similar cases utilized autogenous bone grafting. Standard post-operative practices should be followed, particularly as applicable to defect repair involving the use of internal fixation devices. The patient should be cautioned against early weight bearing and premature ambulation which could lead to loosening and/or failure of the internal fixators or loss of reduction. The length of time the defect must remain in a reduced state of loading is determined by the complexity of the patient's defect(s) and the overall physical condition of the patient. Do not lift heavy items. Hardware should not be removed until the defect is completely healed and the articular area is no longer subjected to abnormal or irregular loading.
This device is restricted to sale, distribution, and use by or on the order of a physician: 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.
Possible adverse effects include but are not limited to: 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.
Sterilization: This product is for single use only. Bongros is supplied sterile in dated, individual, triple aseptic packages. The package should be inspected prior to use to ensure that the sterile barrier has not been compromised. The device should not be used after the expiration date on the package label. This product should not be resterilzed.
Store in the temperature 1°-30°C. Keep away from sunlight.
Shelf life: 36 months.
M05B - DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION ; Used in the treatment of bone diseases.
Granules (vial) 250 mg x 5 cc x 1's, 10 cc x 1's.