National Football League linemen have high return-to-play rates after lumbar diskectomy. Furthermore, because those linemen requiring revision decompression successfully returned to play 85.7% of the time, this cohort should not be denied surgical treatment after recurrent problems. Although the data in our study suggest that National Football League linemen who are treated surgically have superior outcomes to those treated nonoperatively, because of the limitations with the methodology used in this study, further prospective studies are necessary to accurately compare treatment effects and to determine the long-term prognosis for these athletes after retirement.
Long fusions to the sacrum in adults with scoliosis continue to have a high complication rate. As compared to the original publications in the 1980s (Kostuik and Hall, Spine 1983;8:489-500; Balderston et al, Spine 1986;11:824-9) the more recent articles have shown a reduction, but not elimination of the pseudarthrosis problem using segmental instrumentation and anterior fusion of the lumbar spine coupled with structural interbody grafting at L4-L5 and L5-S1. Two-year follow-up is inadequate as pseudarthrosis and painful implants often are detected later. Only 3 of the 12 patients with pseudarthrosis were detected within the first 2 years after surgery.
Objective: The objective of this study was to present an unbiased report of the current rate of severe complications for Federal Drug Administration (FDA) 510(k) cleared sacroiliac joint (SIJ) fusions and investigate the underlying cause of these complications.
Summary of Background Data:The number of yearly SIJ fusions is on an upward trend. Currently, the most utilized implants to fuse the SIJ have been FDA 510(k) cleared devices. Studies reporting on complications following SIJ fusions are mostly industry-sponsored.
Materials and Methods:The Manufacturer and User Facility Device Experience (MAUDE) database was searched for all reported FDA 510(k) cleared SIJ fusion device complications. Several data points were obtained from each report and recorded. The Hospital Inpatient National Statistics and the Center for Medicare and Medicaid Services (CMS) was also searched for the number of SIJ fusions performed each year.Results: A search of the MAUDE database returned 1115 reports, with the first report on June 30, 2011, and the last report on July 28, 2020. Patient injury was the most common type of event reported at 97.5% (1080/1107). Death was reported in 3 patients (0.3%). Malposition was the most common device problem at 49.5% (548/ 1107). The root cause of these events was primarily user error at 58.2% (644/1107). Revision surgery or reoperation occurred in 92.8% (1028/1107) of reports. Data for SIJ fusions through CMS showed an overall trend of increasing yearly SIJ fusions.
Conclusions:The majority of complications reported to MAUDE for FDA 510(k) cleared SIJ fusion devices are user error due to improper placement of implants. These complications are likely underreported, and there is currently no formal tracking system of total SIJ fusions performed to calculate accurate complication and revision rates. Patient injury and health care costs can potentially be reduced with improved education, training, and oversight, which is currently lacking.
Femoral neck stress fractures can result in devastating problems for young adults. Appropriately treated patients, regardless of treatment method, may have persistent complaints.
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