The First 18 Months Following Food and Drug Administration Approval of Lumbar Total Disc Replacement in the United States: Reported Adverse Events Outside an Investigational Device Exemption Study Environment

SAS Journal - Tập 1 - Trang 8-11 - 2007
Scott L. Blumenthal1, Richard D. Guyer1, Fred H. Geisler2, Paul C. McAfee3, John J. Regan4
1The Texas Back Institute, Plano, Tex
2The Illinois Neuro-Spine Center at Rush-Copley Medical Center, Aurora
3The Spine and Scoliosis Center, St Joseph's Hospital, Towson, Md
4The West Coast Spine Institute, Beverly Hills, Calif

Tài liệu tham khảo

Manufacturer and User Facility Device Experience (MAUDE). Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM. Accessed February 22, 2007. 21 CFR, Vol 8, Part 803. Revised April 1, 2006. Blumenthal, 2005, Spine, 30, 1565, 10.1097/01.brs.0000170587.32676.0e Geisler, 2004, J Neurosurg Spine, 1, 143, 10.3171/spi.2004.1.2.0143 McAfee, 2005, Spine, 30, 1576, 10.1097/01.brs.0000170561.25636.1c Fairbank, 2000, The Oswestry Disability Index, Spine, 25, 2940, 10.1097/00007632-200011150-00017