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Spinal Fusion Recall
Mariah Heimon 24 October 2012
Transcript of Spinal Fusion Recall
When in use of an anterolateral or posterior non-pedicle screw fixating, it is intended for degenerative disc diseases, spondyloisthesis, deformities, tumors, pseudoarthrosis, previous failed fusions and trauma (Spinal Fixation System). Spinal Fusion Recall Mariah Heim
Biotechnical Engineering The symptoms On a daily basis, the spine needs to support many neccessary stresses and strains. When the spine has too much movement, or proven to be un-stable, spinal fixation is required. People who tend to feel pain upon movement in their lower back or experience a tingling sensation in an arm or leg usually have the symptoms of a spinal compression and would need this procedure (Spinal). Main Problems Other problems leading to spinal fixation include scoliosis, where the spine bends in abnormal positions, fractures, infections or tumors, which causes the spine to be unstable. With the procedure, it will provide better support by fusing the bones together with screws, rods and metal plates. In cases where the patient has a tumor, it could help keep the spine mobile and thus preventing blood clots (Spinal). Structure Internal fixation will maintain position and alignment and helps prevent motion of the spine. Plates and rods are attached to the vertebral body or elements or wire, screws and hooks. Radiologists and exposed to many new techniques and instruments. They are needed to be able to identify plates, screws, wires, and graphs in order to understand their function in the cervical spine, to treat fractures, fusions, and prevent diseases (Spinal). What the System Offered The Blackstone ICON Modular Spinal Fixation System was produced to be a reliable system in which it guarantees swift assembly and a secure, durable construct with it's accommodating and streamlined features. The multi-axial screws come in diameters from 4.5mm to 8.5mm in a 1mm increment. The length of the screw varies from 25mm to 60mm and have 5mm increments. This system would provide a various lateral offset device, in order to avoid any rod bending, and is set together with a full hook system (ICON). The Problem Several companies have been investigated for participating in illegal schemes. Doctors and surgeons would over-dramatize test results, inducing patients to construct to unnecessary surgeries. On April 17, 2006, Blackstone Medical, Inc. was investigated on their ICON Modular Spinal Fixation System (Orlando).
Within the testing, it turns out that right after the procedure, the pedicle can become loose and can separate from the screw heads or the rods between the spinal segments. In this unfortunate event, it would prevent the spine from fusion together, causing additional surgeries to remove or reform the previous implant (Blackstone). From the 484 surgeries they produced, because of the company's cheap screws, at least 4% had reported that their brace was loose (Spinal Fixation. Part 1.). Results Summary -The system was unsafe, the screws and assemblies created high risk factors, and no actions were made to reduce that risk.
-Failed to establish and maintain Corrective and Preventive Action (CAPA) procedures, but was still sold on the market; they do not identify all the system issues and disengagement of screws, and tend to lend to a recall.
-Failed to perform an adequate investigation, documentations incomplete or not submitted (Department). Improvements The ICON Modular Spinal Fixation System could have been improved with the possession of better rods and screws. Two years after the recall, screws have been produced with bio-absorbable material. This material combines strength for the internal fixation and has the advancement of not forcing metal to be encased inside the body (Spinal). New Scans Improved equitment has also helped the concern from the spinal fixation. MRI scans and bone scans using special dyes will show and boney defects in better detail. This helps to decide whether a spinal fixation is even required. Now, the number of patients with disc disease or lower back pain are very limited on receiving a spinal fusion (Spinal). A New Device The resorbable fixation device, used in some instances today, is made from a bio-resorbable substance, such as one of the polymer products. However, one down side is that when using the device, there needsto be another device to prevent acid damage to the bones inside the body (Spinal). Citations Blackstone Medical, Inc. ICONÂ® Modular Spinal Fixation System. (n.d.). U S Food and Drug
Administration Home Page. Retrieved October 23, 2012, from http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm062942.htm
Department of Health and Human Services. (2009, March 13). Elsevierbi. Retrieved October 24, 2012,
ICON Spinal Fixation System with cannulated pedicle screws. (n.d.). Medifield. Retrieved October 23,
2012, from http://medifield.com/med/en/products/spine/thoracolumbar/posterior/icon-spinal-fixation-system
Orlando, Florida Failure to diagnose Cancer Attorneys & Lawyers. (n.d.). Orlando Personal Injury
Lawyers, Florida Accident Attorneys. Retrieved October 24, 2012, from http://www.thefloridafirm.com/blackstone.html
Spinal Fixation. (n.d.). Medical Tourism | Affordable Cosmetic Surgery | Cosmetic Dental Abroad -
Orange County, Los Angeles, San Diego Riverside. Retrieved October 23, 2012, from http://gme-surgical.com/Procedures/General-Surgeries/Spine-Surgery/Spinal-Fixation.html
Spinal fixation. Part 1. Principles, ba - PubMed Mobile. (n.d.). National Center for Biotechnology
Information. Retrieved October 24, 2012, from http://www.ncbi.nlm.nih.gov/m/pubmed/8460224
Spinal Fixation System (SFS). (n.d.). Orthofix is a diversified orthopedic products company offering
innovative minimally invasive surgical and nonsurgical products. Retrieved October 24, 2012, from http://us.orthofix.com/products/sfs.asp?cid=35