Bongener Special Precautions

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.