Select Osseous Defects
Proper surgical techniques are necessarily the responsibility of the medical professional. The following guidelines are furnished only as recommended techniques. Each surgeon must evaluate the appropriateness of the techniques based on his or her own medical training and expertise. Every patient is different and patient results may vary. Before use, physicians should review all risk information, which can be found on the packaging and in the “Information for Use” attached to the packaging.
This product is intended to be utilized only for select osseous defects which have been documented either by biopsy or clinical-radiographic parameters.
Localize the defect under fluoroscopy. Create cortical access to facilitate curettage.
Using an image intensifier, excise the defect using a curette to debride defect margins. Excised tissue should be sent to pathology for routine histological examination and culture.
Having debrided the defect area, use the included delivery needle to inject PRO-DENSE™ Graft into the defect. (Mix material according to mixing instructions included in the package insert.) Care should be taken to avoid pressurization of the defect site.
*Actual injection delivery time and volume are dependent on close adherence to supplied mixing instructions.
PRO-DENSE™ resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.The PRO-DENSE™ paste cured in situprovides an open void/gap filler that can augment provisional hardware (e.g. K Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.PRO-DENSE™ is provided sterile for single use only.
The PRO-DENSE™ Bone Graft Substitute injectable paste 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
Severe degenerative bone disease
Closed bone void/gap filler
Uncooperative patients who will not or cannot follow postoperative instructions, including individuals who abuse drugs and/or alcohol
Renal compromised patients
Patients with a history of or active Pott’s disease