Bongener

Demineralized bone matrix.

Bongener is made using Demineralized bone matrix (DBM) which contains Bone Morphogenic Proteins (BMPs).
Bongener is formulated into a gel-like form and is provided in a sterile, single use package. It is packaged in various sizes by volume for single patient use.

Bongener is intended for use as a bone graft substitute in bony voids or gaps that are not intrinsic to the stability of the bony structure. Bongener is intended for filling bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis), and filling and/or augmenting intraoral/maxillofacial osseous defect. These defects may be surgically created osseous defetcts or osseous defects created from traumatic injury to the bone. The product provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

Bongener is contraindicated where the device is intended as structural support in load-bearing bone and in articulating surfaces.
Conditions representing relative contraindications include: Severe vascular or neurological disease;
Uncontrolled diabetes;
Severe degenerative bone disease;
Uncooperative patients who will not or cannot follow postoperative instructions, including individuals who abuse drugs and/or alcohol;
Renal impairment;
Active or latent infection in or around the surgical site.
Bongener is contraindicated where there is significant vascular impairment proximal to the implantation site and when there are metabolic or systemic bone disorders that affect bone or wound healing, or when stabilization of the defect is not possible. The use of Bongener is contraindicated in cases where intraoperative soft tissue coverage is not planned or possible and in infected or contaminated sites.

Bongener is sterile during the stated shelf life in an unopened and undamaged package. The product must be used prior to the expiration date.
Do not use if the packaging has been damaged and/or the product has been contaminated. In the event of contamination, discard the product.
Appropriate placement and/or fixation are critical factors in the avoidance of potentially adverse effects.
As with all biological products, the tissue in Bongener has the potential to transmit infectious agents despite processing treatments, extensive donor screening, tissue selection and laboratory tests. To date, there have been no reports of experimental or clinical viral seroconversion using demineralized bone powder.
When filling a closed defect, care must be taken while extruding Bongener from the syringe as possible pressurization of the device could result in fat embolization and/or embolization of the material into the blood stream.
As with any surgical procedure, the possibility of infection exists.
Although the production technique is designed to eliminate antigenic properties of the product, the possibility of such a reaction is present.
Adverse outcomes potentially attributable to the product must be reported promptly to the manufacturer.
When introducing Bongener, care must be taken to avoid excessive compaction.
Overfilling the implantation site must be avoided to achieve a tension-free closure of the wound.

Instructions for Use: These instructions are intended as guidelines for the use of Bongener as a part of established surgical techniques. They are not intended to replace or change standard procedures for treatment of bone defects involving bone grafting and internal fixation. Procedures involving bone grafting can experience highly variable results. Factors to be considered in selecting bone grafting material and the surgical technique to be utilized are as follows: Age of patient;
Quality of the patient's bone;
Location of the defect;
Anticipated loading conditions;
Proximity of the graft to a suitable blood supply;
Ability to achieve direct apposition of the graft to viable host bone;
Presence/addition of autogenous bone or bone marrow at the graft site;
Elimination of gaps in the graft site;
Complete coverage of the graft material to prevent migration.
For best results, extreme care should be exercised to assure the correct graft materials selected for the intended application.
Preoperative Preparation: Aseptic technique must be maintained to minimize the risk of postoperative complications. The amount needed is based on the type of procedure and the size of the defect being treated. Bongener does not require rehydration prior to use. Radiological evaluation of the defect site is essential to accurately assess the extent of the defect and to aid in the selection and placement of Bongener and fixation devices.
Surgical Procedure Note: Bongener does not possess sufficient mechanical strength to support reduction of a graft site prior to tissue growth. Therefore, anatomical reduction and rigid fixation in all planes, should be obtained independent of Bongener.
For best results, Bongener must fill the defect and contact as much viable bone as possible. Bongener must not be used to repair bone defects where complete soft tissue coverage cannot be achieved. Only experienced physicians, who have had appropriate training and experience in the field of implant materials and implant surgery, should use Bongener.
Postoperative Care: Postoperative patient management should follow the same regimen as similar cases utilizing autogenous bone grafting. Standard postoperative practices should be followed, particularly as applicable to defect repairs involving the use of fixation devices. The patient should be cautioned against early weight bearing and premature ambulation which could lead to loosening and/or failure of the fixators or loss of reduction.
The length of time a defect should remain in a reduced state of loading is determined by the complexity of the defect site and the overall physical condition of the patient. Hardware should not be removed until the defect is healed.
Sterilization: Bongener has been sterilized by gamma irradiation. The inner package and its contents are sterile. The package should be inspected prior to use to ensure the stability barrier has not been compromised. This product is for single use only and may not be re-sterilized. The product must not be used beyond the stated expiration date.

Do not refrigerate or freeze. Do not expose to extreme heat. Store at room temperature (15°C to 30°C) in a clean, dry place.

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