Bongener Caution For Usage

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.