Some may be used in combination with each other during the spine surgery.
These include using the patient’s own bone (autograft), using cadaver bone (allograft), using a bone graft substitute or bone morphogenetic protein (BMP). This article reviews the main options available for bone graft. screws and rods) is typically used to provide stability for that section of the spine for the first few months after surgery over the long term, a solid fusion of bone that has healed together provides stability. Instead, the bone graft provides the foundation and environment to allow the body to grow new bone and fuse a section of the spine together (into one long bone).Īt the time of the fusion surgery, instrumentation (e.g. The bone graft does not form a fusion at the time of the surgery. Bone graft and/or bone graft substitute is needed to create the environment for the solid bridge to form. Request PDF i-Factor Bone Graft vs Autograft in Anterior Cervical Discectomy and Fusion: 2-Year Follow-up of the Randomized Single-Blinded Food and Drug Administration Investigational Device. This record will be updated as the status changes.In a spinal fusion, a solid bridge is formed between two vertebral segments in the spine to stop the movement in that section of the spine. Cerapedics is now actively involved in introducing the i-FACTOR Bone Graft. From these roots, Cerapedics has reformulated the (ABM/P-15) product and branded it i-FACTOR Peptide Enhanced Bone Graft to capture the unique attachment factor mechanism of action. Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ The manufacturer has initiated the recall and not all products have been corrected or removed. Since approval, ABM/P-15 has been used in an estimated 500,000 procedures. i-FACTOR Bone Graft is a composite bone substitute material consisting of a synthetic cell-binding domain of Type I human collagen (P-15) adsorbed onto anorganic bone mineral. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Bone grafts are medical devices that are in high demand in clinical practice for substitution of bone defects and recovery of atrophic bone regions. i-FACTOR Putty combines a unique anorganic bone mineral (ABM) and small peptide (P-15) that acts as an attachment factor for specific integrins on osteogenic cells. Two product forms (Putty and Flex) allow clinicians to choose the handling characteristics best suited to specific applications. Nationwide distribution in the states of AL, AZ, CA, CT, DC, DE, ID, IN, KS, KY, MD, MI, MN, MO, NC, NV, NY, OH, PA, TX, VA, and WA.ġ A record in this database is created when a firm initiates a correction or removal action. i-FACTOR bone graft is easy to use in a wide range of orthopedic and spine procedures. The material is not osteoinductive nor morphogenetic. The 'attract, attach, activate' mechanism of action promises safety, as it maximizes the potential for native biology to heal.
Questions or assistance - contact Customer Service at 1-86. 'i-FACTOR Bone Graft is simply making use of, and amplifying, the natural bone forming process,' explained Dr. email a "Medical Device Recall" letter to customer informing them that the firm is voluntarily recalling all units of i-FACTOR 1.0cc Putty from lot 21C0991 due to the incorrect product code on the patient chart label.ġ) Examine their inventory and return any remaining units from lot 21C0991 using the provided RMA number.Ģ) Respond to the Recall email or call toll free at 1-86 to report the number of units at their location.ģ) If the affected product has been further distributed, notify those customers of the recall utilizing the recall notification letter. Patient chart label contains incorrect Part Number and volume amount. UDI Code: (01)00850001680004(17)240531(10)21C0991 More than a Simple Scaffold.i-FACTOR Peptide Enhanced Bone Graft is an advanced biologic that is supported with level I human clinical evidence, satisfies. Putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY A prospective randomized paired design was used. Class 3 Device Recall iFACTOR Peptide Enhanced Bone Graft Puttyįiller, bone void, synthetic peptide - Product Code NOX The synthetic bone graft used was ABM/P-15 as i-Factor Flex strip (Cerapedics, Westminster, CO, USA), which was a combination of freeze-dried AMB granule, 50 m in size, coated with P-15 peptide.
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