i-FACTOR Peptide Enhanced Bone Graft has not been tested in patients with. Use of i-Factor™ in anterior cervical discectomy and fusion is effective and safe, and results in similar outcomes compared to local autograft bone at 2 yr following surgery. Six-year follow-up of i-FACTOR peptide enhanced bone graft vs autograft in single level ACDF in a randomized single blinded FDA investigational device. i-FACTOR Peptide Enhanced Bone Graft has not been tested in patients who have liver (hepatic) or kidney (renal) disorders. There were no allergic reactions associated with i-Factor™. Twelve (7.45%) i-Factor™ subjects and 16 (10.53%) autograft subjects underwent re-operation ( P =. The composite endpoint of overall success (fusion, Neck Disability Index improvement >15, neurological success, and absence of re-operations) was greater in i-Factor™ subjects compared to autograft subjects (69.83% and 56.35%, respectively, P =. 4507), and SF36v2 Mental Component Score improved 7.88 (i-Factor TM) and 7.53 (autograft P =. 1652), Short Form-36 (SF-36v2) Physical Component Score improved 10.23 (i-Factor™) and 10.18 (autograft P =.
2763) Visual Analog Scale neck pain improved 4.78 (i-Factor™) and 4.41 (autograft P =. 1448) Visual Analog Scale arm pain improved 5.43 (i-Factor™) and 4.97 (autograft) (p =. Neck Disability Index improved 28.30 (i-Factor™) and 26.95 (autograft P =. 2513), and neurological success rate was 94.87% (i-Factor™) and 93.79% (autograft P =. RESULTSĪt 2 yr, the fusion rate was 97.30% and 94.44% in i-Factor™ and autograft subjects, respectively ( P =. Subjects randomly received either autograft (n = 154) or i-Factor™ (n = 165) in a cortical ring allograft and followed using radiological, clinical, and patient-reported outcomes. A pivotal, noninferiority, US FDA Investigational Device Exemption study demonstrated the benefits of i-Factor™ compared to local autograft bone in single-level anterior cervical discectomy and fusion at 1-yr postoperative. This record will be updated as the status changes.I-Factor™ Bone Graft (Cerapedics Inc, Westminster, Colorado) is a composite bone substitute material consisting of P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral suspended in an inert biocompatible hydrogel carrier. 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. 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. 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. If you need a bone substitute for your surgery. Go directly to home page Go directly to navigation 1. By clicking Accept you consent to the use of cookies. Questions or assistance - contact Customer Service at 1-86. This site uses cookies to offer you a better browsing experience.
#Ifactor bone graft code#
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.
#Ifactor bone graft pdf#
Patient chart label contains incorrect Part Number and volume amount. 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. The scaffold for the bone graft is a sponge made from bovine collagen. This protein stimulates and regulates the growth and healing of bone tissue. The first is an engineered protein based on human bone protein, called rhBMP-2. Putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY The INFUSE Bone Graft includes two main components that make it work for re-growing bone and healing spinal discs. Class 3 Device Recall iFACTOR Peptide Enhanced Bone Graft Puttyįiller, bone void, synthetic peptide - Product Code NOX
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