THE BUILDING BLOCKS OF BONE FUSION. Medline Demineralized Bone Allografts Safe and Effective Grafting Options

Transcription

1 THE BUILDING BLOCKS OF BONE FUSION. Medline Demineralized Bone Allografts Safe and Effective Grafting Options

2 2 MEDLINE

3 BUILD ON QUALITY. Successful bone fusion and osteogenesis depend on a number of factors including the quality of your grafts. Thanks to an extensive donor screening process and an advanced, multi-step cleansing process, Medline s demineralized bone allografts provide you with a safe and effective foundation for your patient s new bone formation and bone healing. CONTENTS Engineered for Patient Safety and Positive Outcomes... 3 DBM Putty and DBM Putty + CCC (Crunch)... 7 Demineralized Cancellous Sponges...8 Ordering Information... 9 Common Applications and Surgical Procedures...10

4 ENGINEERED FOR PATIENT SAFETY AND POSITIVE OUTCOMES. Extensive Screening Medline allograft tissue is aseptically recovered by highly trained, certified tissue bank specialists, and processed by AATB-accredited and FDA-registered tissue bank facilities. All potential donors are subjected to an extensive screening evaluation that includes: Medical History Physical Assessment Social History Autopsy Review (when available) Cause of Death Extensive Serological and Microbiological Screening by CLIA-Certified Lab

5 Extensive Serological and Microbiological Screening by CLIA- Certified Lab includes: Human Immunodeficiency Virus Type 1 Antibody Human Immunodeficiency Virus Type 2 Antibody Hepatitis C Virus Antibody Hepatitis B Surface Antigen Hepatitis B Core Antibody (total) Syphilis Rapid Plasma Reagin or Treponemal Specific Assay HIV1/HCV Nucleic Acid Test (NAT) Human T-Cell Lymphotropic Virus Type I Antibody Human T-Cell Lymphotropic Virus Type II Antibody MEDLINE ( ) medline.com 5

6 Advanced Processing and Cleansing In addition to being irradiated using gamma radiation to achieve a Sterility Assurance Level (SAL) of 10-6, our grafts are subjected to an advanced, multi-step cleansing process. 6 MEDLINE

7 1 4 Aseptic tissue debridement and cleaning to remove blood, lipids and marrow Multiple sterile water and/ or saline rinsing stages to remove reagents and other excess substances 2 5 Decontamination from bacteria and other pathogens using antimicrobial reagents including surfactants, alcohol, and/or peroxide followed by centrifugation to remove moisture 3 6 Forced permeation of cleansing solutions through tissue (bone matrix) followed by high-pressure air compression purging to ensure disinfection Ultrasonication and other methods used to remove residual reagents and moisture Controlled temperature and freeze/thaw cycles to preserve tissue integrity

8 DBM PUTTY AND DBM PUTTY + CCC* (CRUNCH) Available in two forms (putty and crunch) to accommodate surgeon preference, Medline DBM offers several benefits: Superior handling characteristics moldable and irrigation resistant for effortless application Does not contain synthetic polymer carriers, which do not facilitate the bone healing process Pre-loaded in a syringe for speed and convenience, no mixing or re-hydration required Osteoconductive and tested for osteoinductive potential (i.e. presence of BMP-2) 100% Human Allograft Tissue Terminally Sterilized to *Corticocancellous Chips

9 DEMINERALIZED CANCELLOUS SPONGES Available in a variety of sizes and shapes, including strips, cubes and filler, Medline demineralized cancellous sponges provide ideal characteristics for successful bone fusions: Osteoconductive 100% cancellous bone promotes cellular in-growth Natural trabecular structure absorbs and delivers bioactive fluids like bone marrow aspirate (BMA) and platelet-rich plasma (PRP) to your fusion site Compresses and expands to fill narrow bone voids and implant graft windows 100% Human Allograft Tissue Terminally Sterilized to MEDLINE ( ) medline.com 9

10 ORDERING INFORMATION Item Description Quantity MA32600 DBM Putty, 0.7 cc 1 syringe MA32601 DBM Putty, 1 cc 1 syringe MA32602 DBM Putty, 2.5 cc 1 syringe MA32605 DBM Putty, 5 cc 1 syringe MA32610 DBM Putty, 10 cc 1 syringe MA32601C DBM Putty + Corticocancellous Chips, 1 cc 1 syringe MA32602C DBM Putty + Corticocancellous Chips, 2.5 cc 1 syringe MA32605C DBM Putty + Corticocancellous Chips, 5 cc 1 syringe MA32610C DBM Putty + Corticocancellous Chips, 10 cc 1 syringe MA70808 Cancellous Sponge Cube, 8 mm 1 each MA70810 Cancellous Sponge Cube, 10 mm 1 each MA70812 Cancellous Sponge Cube, 12 mm 1 each MA70814 Cancellous Sponge Cube, 14 mm 1 each MA74805 Cancellous Sponge Strip, 5 x 50 mm 1 each MA74801 Cancellous Sponge Strip, 10 x 50 mm 1 each MA74818 Cancellous Sponge Strip, 15 x 20 mm 1 each MA74815 Cancellous Sponge Strip, 15 x 40 mm 1 each MA74830 Cancellous Sponge Strip, 20 x 30 mm 1 each MA74850 Cancellous Sponge Strip, 20 x 50 mm 1 each MA71801 Cancellous Sponge Filler (1-4 mm), 1 cc 1 package MA71802 Cancellous Sponge Filler (1-4 mm), 2 cc 1 package MA71805 Cancellous Sponge Filler (1-4 mm), 5 cc 1 package MA71810 Cancellous Sponge Filler (1-4 mm), 10 cc 1 package MA71815 Cancellous Sponge Filler (1-4 mm), 15 cc 1 package Store at room temperature. Three-year shelf life. 10 MEDLINE

11 Common Applications and Surgical Procedures. Spine Anterior Cervical Fusions (ACF/ACDF) Posterior Cervical Fusions (PCF/PCDF) Posterior Lumbar Interbody Fusions (PLIF) Anterior Lumbar Interbody Fusions (ALIF) Corpectomies with Fusion General Ortho & Trauma Bone Voids Hip/Total Joint Revisions General Ortho Reconstructions Osteodefects Foot & Ankle Fusions (Arthrodesis) Fractures Osteotomies

12 BETTER VIEW. BETTER PROTECTION. BETTER PACKAGING. Large window for a true view of the actual graft and important information Lets you select the right graft without removing it from the packaging Plastic film protects inner sterile packaging from exposure to dirt and debris Ensures delivery of a clean package into the sterile O.R. environment Talk to your Medline Sales Rep about all available Allografts. FOLLOW US BLOG Medline Industries, Inc. One Medline Place, Mundelein, IL Medline United States MEDLINE ( ) medline.com info@medline.com Some products may not be available for sale in Mexico or Canada. We reserve the right to correct any errors that may occur within this brochure Medline Industries, Inc. All rights reserved. Medline is a registered trademark of Medline Industries, Inc. MKT / LIT286R / 2M / VP / 10