Bongros Special Precautions

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Full Prescribing Info
Special Precautions
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.
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