Analysis of Complications in Sacroiliac Joint Fusions Using FDA 510(k) Cleared Devices

Abstract

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.

Long-Term Outcomes in Obese, Severely Obese, and Morbidly Obese Patients having Open Posterior Midline Sacroiliac Joint Fusions for Disabling and Dysfunctional Sacroiliac Joint Pain

“…This is the first paper to discuss long-term outcomes in obese patients having open sacroiliac joint surgeries. The current vogue fusion surgery for the sacroiliac joint is the lateral minimally invasive fusion using devices that fall under the FDA 510(k) designation [7,8]. Although obese patients undoubtedly occupy the ranks of the tens of thousands of patients having had these surgeries, no study has looked specifically at the BMI for differences in outcomes.…”

“…This paper evaluates long-term outcomes in obese patients undergoing posterior midline open SIJ fusion procedures occurring over a five-year period. This study provides new baseline data on obese SIJ fusion patients, which will need future revisions as this population of SIJ fusion patients is further studied and reported on, especially considering the current wave of lateral and posterior lateral minimally invasive FDA 510 (k) designated SIJ fusions being performed [7,8].…”

Revision of Failed Sacroiliac Joint Posterior Interpositional Structural Allograft Stabilization with Lateral Porous Titanium Implants: A Multicenter Case Series [Letter]

“…There were three patient deaths, 50% of the SAEs were malposition implants, 58% had nerve root injury, 92% required revision surgery, and more than 50 reported cases of hemorrhages, pelvic fractures, intra-abdominal violations, and non-unions. 3 The revision rate for this triangular titanium device has been reported as high as 5.7%. 4 We were surprised by the authors' reported average pain relief of 89%, well beyond any published data for lateral porous titanium implants 5 referenced by the authors, with the average pain relief of 64%.…”

Letter: Neurosurgical Educational Societies Need to Be More Involved in Surgical Education and Certification for Sacroiliac Joint Surgery

“…Approximately 60 000 minimally invasive sacroiliac joint (SIJ) fusion surgeries have been performed in the United States over the past decade, with approximately 10 000 currently being performed annually. 1 Neurosurgeons comprise a significant number of the surgeons preforming these surgeries. The primary cause for the dramatic increases in the numbers of SIJ fusions stems from one company in 2008 requesting a 510 (k) designation for their device to fuse the SIJ from the Federal Drug Administration (FDA).…”

“…7,8 Formal education on the surgical treatment for the chronically painful dysfunctional SIJ is currently nonexistent in medical schools, surgical residency programs, spine fellowships, and all the major surgical education societies to include CNS, AANS, NASS, and the AAOS. 1,8 Thus industry, who manufactures the devices used in their procedures, has become, by default, the primary educator for the surgeons, both orthopedic and neurosurgery, who are preforming today's SIJ fusion surgeries on these tens of thousands of patients. This should be alarming to patients, surgeons, and anyone involved in surgical patient care for the SIJ.…”