Indications
Pro-Dense Injectable Regenerative Graft 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 adult 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.
Pro-Dense Injectable Regenerative Graft cured in situ provides an open void/gap filler that can augment provisional hardware (e.g., KWires) 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 Injectable Regenerative Graft is provided sterile for single use only.
Contradications
Pro-Dense Injectable Regenerative Graft is contraindicated where the product 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
- Closed bone void/gap filler
- Pregnancy
- Uncooperative patients who will not or cannot follow postoperative instructions, including individuals who abuse drugs and/or alcohol
- Hypercalcemia
- Renal compromised patients
- Patients with a history of or active Pott’s disease
Adverse events
Possible adverse effects include but are not limited to:
- Wound complications including hematoma, site drainage, bone fracture, infection, and other complications that are possible with any surgery
- Fracture or extrusion of the bone void filler, with or without particulate debris generation
- Deformity of the bone at the site
- Incomplete, or lack of, osseous ingrowth into bone void, as is possible with any bone void filler
- Transient hypercalcemia
- Potential to pressurize material in a closed void, which could result in fat embolization and/or embolization of the device material into the blood stream
Individual results and activity levels after surgery vary and depend on many factors including age, weight and prior activity level. There are risks and recovery times associated with surgery and there are certain individuals who should not undergo surgery. Only a physician can tell you if this product and associated procedure are right for you and your unique circumstances. Please consult with a physician for complete information regarding benefits, risks, anticipated implant duration and possible outcomes.
A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery. The information presented is intended to demonstrate the breadth of Stryker’s product offering. A surgeon must always refer to the package insert, product label and/or instructions for use, including the instructions for cleaning and sterilization (if applicable), before using any of Stryker’s products. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your representative if you have questions about the availability of Stryker’s products in your area.
Stryker or its affiliated entities own, use, or have applied for the following trademarks or service marks: Stryker. All other trademarks are trademarks of their respective owners or holders.
The absence of a product, feature, or service name, or logo from this list does not constitute a waiver of Stryker’s trademark or other intellectual property rights concerning that name or logo.
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