It is indicated that screws medially misplaced at a distance greater than 2-mm, especially 4 mm, may be a cause of negative effects on the neural structure and should be removed during the early phase of the postoperative period, even among patients without postoperative neurological abnormalities. On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. Yuan HA, Garfin SR, Dickman CA, Mardjetko SM: A historical cohort study of pedicle screw fixation in thoracic, lumbar and sacral spinal fusions. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. However, we did not observe any screw breakage in patients with a degenerative lumbar spine, and the absence of broken screws in this series is because arthrodesis in almost all patients occurred in situ. Delayed open treatment of aortic penetration by a thoracic pedicle INCLUDE WHEN CITING DOI: 10.3171/2020.8.FOCUS20600. Spine 18:11601172, 1993. J Neurosurg Spine. Cerebrospinal fluid fistulas. A p < 0.05 was considered statistically significant. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? There were 74 men and 38 women, with a mean age of 47 years (range, 1872 years). Breakage of a divergent screw of a Chopin block at the lumbosacral area was seen 3 months after surgery. Disclaimer. Clin Orthop 203:4553, 1986. Several studies reveal that fusion rates increase when rigid internal fixation is used, 14,20,21,33,38 and that by using pedicle screws and plates or rods for stabilization, spinal arthrodesis can be limited to the disease segments. The patient had subsequent coronal imbalance and degeneration of the upper disc. Johnston II CE, Ashman RB, Baird AM, Allard RN: Effect of spinal construct stiffness on early fusion mass incorporation: Experimental study. In order to prove medical malpractice occurred, the plaintiffs attorney needs to show not only the plaintiff experienced a poor medical outcome, but that it was directly caused by medical negligence. J Bone Joint Surg 61A:201207, 1979. 3. The jury found the defendants liable and allocated 75 percent of the fault to Dr. Friedlander and 25 percent to Dr. Bradley. [] Computer-assisted computed tomography (CT) techniques have improved the overall accuracy for pedicle screw placement, and has reduced complication rates. 1. Neurological Outcome and Management of Pedicle Screws Misplaced Totally A retrospective review of closed medicolegal cases with verdicts or settlements between 1995 and 2019 was performed using the Westlaw Edge legal research database (Thomson Reuters).7,14,16,23,24 A search of closed federal and state malpractice claims within the Verdicts and Settlements section consisted of the following: spine and surgery and pedicle and screw and fusion and (misplaced or misguided or mispositioned) and surgeon. Inclusion criteria consisted of malpractice claims against surgeons for complications related to misplaced pedicle and/or lateral mass screws. While the majority of verdicts are found in favor of the defendant (surgeon), over 30% of cases in this study were found in favor of the plaintiff (patient), resulting in average inflation-adjusted payouts of over $1.2 million per claim over the past 25 years. However, the defendant doctor maintained that Nyquists foot drop was not caused by the misplaced screw. What can spine surgeons do to improve patient care and avoid medical negligence suits? 2012;89(10):7071. Thus, meaningful efforts to limit the rate of misplaced pedicle and lateral mass screws, such as the routine use of intraoperative imaging confirmation and/or computer- or robot-assisted navigation, should be carefully considered. Legal liability in iatrogenic orbital injury. Zdeblick TA: A prospective randomized study of lumbar fusion: Preliminary results. In the current series, including general complications, only 48 patients (43%) had no notable complication and the remaining 64 patients (57%) had one or more complications. Of note, the award amount for one settlement case was undisclosed. Whitecloud III TS, Butler JC, Cohen JL, Candelora PD: Complications with the variable spinal plating system. The third patient, who had central spinal stenosis, was treated by decompression alone. Morphometric analysis of the proximal thoracic pedicles in Lenke II and IV adolescent idiopathic scoliosis: an evaluation of the feasibility for pedicle screw insertion. Of the 112 patients, 57 patients had a lumbar degenerative disorder, (lumbar degenerative spinal canal stenosis in 23 patients, degenerative or spondylolytic spondylolisthesis in 12 patients, postlaminectomy instability or stenosis in 20 patients, and recurrent disc prolapse in two patients), 42 patients had spinal cord injury, eight patients had infection, and five patients had a spinal tumor (Table 1). A TLIF is a surgical procedure that attempts to fuse vertebrae in order to stabilize the patient's spine. In the current study, the arthrodesis rate of 89.4% compares favorably with other previously reported series in the spinal literature, most of which use radiographic means to access the status of the spinal arthrodesis. Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. PLoS One. Operative information including fusion level, number of levels fused, level of misplaced screw(s), single versus multiple misplaced screw(s), presence of known CSF leakage, and primary injury due to screw misplacement was also collected. It should be used by experienced and qualified surgeons who are aware of the pitfalls associated with its use. (PDF) Accuracy of pedicle screw placement in the lumbosacral spine 5. A total of 47 (69.1%) cases resulted in a decision for the defendant and 21 (30.9%) for the plaintiff. Feb. 16, 2021 Accurate placement of pedicle screws is key to avoiding the potential complications of spinal fusion surgery and improving overall spinal fixation. Therefore, when instrumentation is to be used, the benefits must outweigh the risks. Mayo Clinic uses the latest robot-assisted technology when indicated to enhance surgical precision in these procedures. 2017;27(4):470475. However, the impact of robotic-assisted spinal fusion on patient outcomes is less clear. J Bone Joint Surg 54A:11951204, 1972. For more information, please refer to our Privacy Policy. Scarone P, Vincenzo G, Distefano D, et al. SECTION I SYMPOSIUM: Advances in Spine Surgery, Distribution of Spinal Disorders in 112 Patients, Classification of Complications in 64 patients. With pedicle shapes and sizes varying wildly in the scoliotic spine, misplacement of a screwas well as and under- or oversizingare real possibilities in spine surgery. 2012;37(1):6776. Of note, while only 38.2% (n = 26) of cases in our study mentioned the use of intraoperative radiographic confirmation, only one of these cases reported that the misplaced screw had been caught prior to leaving the operating room, which had resulted in an inadvertent dural tear and L5 nerve root injury. Use of the Airo mobile intraoperative CT system versus the O-arm for transpedicular screw fixation in the thoracic and lumbar spine: a retrospective cohort study of 263 patients. pedicle screws sagittal alignment spinal fusion surgical guides Spinal fusion is used to treat a range of conditions associated with spinal column such as intervertebral disc degeneration and scoliosis [ 1 ]. Acquisition of data: Sankey. It should be used by experienced and qualified surgeons who are familiar with the pitfalls associated with its use. We attribute the 24.1% disc space narrowing in the instrumented segments mainly to the severe injury of the disc and communication of the end plate in burst fractures, which could accelerate the disc degeneration and narrowing. 2. The third surgical procedure removed the pedicle screws but left the patient in an unfused state with an unstable spine. Hsu K, Zucherman JF, White AH: Internal Fixation With Pedicle Screws. There were two complete degenerations of the upper disc, one central canal stenosis, and two asymptomatic disc space narrowings and retrolistheses. 2013;123(9):20992103. Misplacement of Pedicle Screws Leads to Years of Pain and Opioid Addiction In addition, the median time to judgment is substantial, particularly for defendant verdicts, spanning over 4.5 years from the time of surgery. In five patients with thoracolumbar injuries, who were the first treated in the current series, and in four patients with fractures in the lower lumbar spine, two-segment fixation was used. The physician ordered an MRI of the lumbar spine which showed that the screws had been misplaced and were puncturing the patient's lumbar nerves. 2020;45(2):E111E119. Quraishi NA, Hammett TC, Todd DB, et al. Screw misplacement. Study design: doi: 10.1097/BPO.0000000000001828. 3. Disclosures Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. J Neurosurg Spine. Privacy Policy. 26. JAMA. Problems in the instrumented segments were considered those occurring from narrowing of the disc space greater than 3 mm, pseudarthrosis, and loss of reduction. The cost of defensive medicine on 3 hospital medicine services. 8600 Rockville Pike Judgment information associated with a defendant (surgeon) versus plaintiff (patient) ruling, trial versus settlement versus arbitration decision, award amount, and time to decision or case closure from index surgery was also recorded. Am J Otolaryngol. Pullout performance comparison of pedicle screws based on cement application and design parameters Tolga Tolunay, Cemile Bagl, Teyfik Demir, Mesut E Yaman, and Arslan K Arslan Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine 2015 229: 11 , 786-793 Download Citation J Spinal Disord Tech. The average age of the patients was 47 years and the average followup was 35 months. Once the spine is exposed, the appropriate levels of fixation are confirmed with the image intensifier. Federal government websites often end in .gov or .mil. Hardware-related failures were observed in 12 patients (10.7%). The pedicle screw system is widely used in spine surgery, and it provides rigid fixation and leads to successful subsequent deformity correction and bony fusion. 4. Except for two patients with spinal metastatic disease, all other patients received an iliac crest autologous bone grafts. Spine 8:970981, 1996. Jena AB, Seabury S, Lakdawalla D, Chandra A. 2011;306(10):1088. to maintaining your privacy and will not share your personal information without Instrumentation removal is an option for patients with successful arthrodesis, but remains controversial. True accuracy of percutaneous pedicle screw placement in thoracic and In four of these patients, bent screws occurred at 8 to 10 months after surgery; in three patients, broken screw necks were seen 1 year after surgery and in two patients, tulip screw plug dislodgments were observed at 4 and 6 months postoperatively, respectively. 70% of Pedicle Screws are misplaced - orthostreams.com Rynecki ND, Coban D, Gantz O, et al. Among the plaintiff-awarded cases, 13 (61.9%) were decided by jury trial, 7 (33.3%) by settlement, and 1 (4.8%) by arbitration. 2017 Mar;5(2):109-116. doi: 10.1016/j.jspd.2016.10.007. The last two patients had a T12L1 fracture-dislocation and a L4L5 spondylolytic spondylolisthesis at the site of plug dislodgments. Figure 1: Lower thoracic pedicles provide the firm purchase of the pedicle screw from a lateral starting point and 10-15 degrees convergent angle Surgical technique "Free Hand" pedicle screw placement [50] Our "Free Hand" technique is equivalent for lumbar and Makhni MC, Park PJ, Jimenez J, et al. Accuracy of pedicle screw insertion by AIRO intraoperative CT in complex spinal deformity assessed by a new classification based on technical complexity of screw insertion. Re: malpositioned pedicle screw resulting in additional surgery and disability. Pedicle Screw Malposition Expert Witness: Malposition Can Lead to A CT scan was taken to try and identify the underlying neurological problem that might be causing the new symptom. Nyquist followed a medical malpractice lawsuit against Dr. Masnyk for his surgical error, alleging that the surgeon had improperly positioned the right L4 pedicel screw which had resulted in a nerve root injury and Nyquists subsequent foot drop. Hardware problems were those related to the physical change of metal and screw position. McLaughlin WM, Donnelley CA, Yu K, Gillinov SM, Tuason DA. MeSH Schatlo B, Molliqaj G, Cuvinciuc V, et al. Over 40% of patients had screws with either some/major concern. Examples of both laterally and medially misplaced lumbar pedicle screws are provided in Fig. Svider PF, Kovalerchik O, Mauro AC, et al. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. $ = US$. From the *Department of Orthopaedic Surgery, University of Crete Medical School, Heraklion, Greece; and the **First Department of Orthopaedics, University of Athens Medical School, Athens, Greece. Pitfall: Unstable injuries. A total of 2724 screws were placed in 127 patients. In this example, the surgeon replaced the misplaced screw prior to leaving the operating room, which arguably played a significant role in the jury ruling in favor of the defendant (surgeon). Illinois Jury Finds in Favor of Doctor in Gallbladder Surgery that Led to Fatal Bowel Perforation Nickl v. Barry S. Rosen, M.D. In situ spine arthrodesis permits load sharing by the vertebral bodies, preventing fatigue failure of the implant. Pedicle screw fixation is commonly used in spinal instrumentation surgeries to connect rods to vertebrae in order to correct spine alignment, stabilize vertebrae, and reach an arthrodesis. The cost of defensive medicine on 3 hospital medicine services, Defensive medicine in neurosurgery: the Canadian experience, Review of neurosurgery medical professional liability claims in the United States, A nine-year review of medicolegal claims in neurosurgery, Malpractice risk according to physician specialty, Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003, Descriptive analysis of state and federal spine surgery malpractice litigation in the United States, Malpractice litigation following spine surgery, Medical malpractice in orthopedic surgery: a Westlaw-based demographic analysis, Malpractice claims in spine surgery in Germany: a 5-year analysis, On average, physicians spend nearly 11 percent of their 40-year careers with an open, unresolved malpractice claim, Malpractice litigation and the spine: the NHS perspective on 235 successful claims in England, Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort, It is easier to confuse a jury than convince a judge: the crisis in medical malpractice, Determining legal responsibility in otolaryngology: a review of 44 trials since 2008, Legal liability in iatrogenic orbital injury, Spine neurosurgeons facing the judicialization of their profession: disenchantment and alteration of daily practicea qualitative study, Malpractice issues in neurological surgery. Harris RI, Wiley JJ: Acquired spondylolysis as a sequel to spine fusion. West et al 33 also reported a 29% complication rate for the first 50 patients and a 26% complication rate for the last 74 patients. Nottmeier EW, Seemer W, Young PM. The rate of misplaced pedicle screws ranges from 1.1% to 28.8%, 10 although neurologic injury from misdirected pedicle screws has been reported to occur in 0% to 12% of patients. However, the medicolegal impact of misplaced screws on spine surgery has not been directly reported in the literature. Rovit RL, Simon AS, Drew J, et al. We serve the following localities: Cook County including Arlington Heights, Barrington, Berwyn Township, Chicago, Des Plaines, Glenview, Orland Park, Palos Park, Schaumburg, and Tinley Park; DuPage County including Downers Grove, Naperville, and Bolingbrook; Kane County including Aurora, Elgin and Geneva; Lake County including Waukegan; and Will County including Joliet. A total of 69 patients (mean age, 67.416 . It is easier to confuse a jury than convince a judge: the crisis in medical malpractice. Except for the patient with an infected pseudarthrosis who had a flat back syndrome (sagittal imbalance) develop, coronal imbalance was observed in five patients (4.5%), and ranged from 7.5 to 12 (Fig 3). J Neurosurg Spine. In six of these patients with injuries at the thoracolumbar area (four patients with bent screws and two patients with broken screws), the loss of correction ranged from 3 to 4.5 without change of anatomic reduction (Fig 1). This site needs JavaScript to work properly. All Rights Reserved. 2014;75(6):609613. ABSTRACT: Pedicle screw loosening has been implicated in recurrent back pain after lumbar spinal fusion, but the degree of loosening has not been systematically quantied in patients. Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003. Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. Bethesda, MD 20894, Web Policies Edmunds I, Cummine J, Fearnside M: Prevention of dislodgement of Cotrel-Dubousset rods from tulip screws. * Analysis and interpretation of data: Sankey, TT Than. Please enable scripts and reload this page. Results: All the incidental dural tears were repaired immediately and produced no clinical sequelae. $ = US$; MW = Midwest; NE = Northeast; SE = Southeast; SW = Southwest; W = West. Clinical Orthopaedics and Related Research, Get new journal Tables of Contents sent right to your email inbox, The Association of Bone and Joint Surgeons, Complications and Problems Related to Pedicle Screw Fixation of the Spine, Articles in Google Scholar by Pavlos Katonis, MD, Other articles in this journal by Pavlos Katonis, MD, Privacy Policy (Updated December 15, 2022). Clipboard, Search History, and several other advanced features are temporarily unavailable. Wiltse LL, Spencer CW: New uses and refinements of the paraspinal approach to the lumbar spine. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiffs spine. Elsamadicy AA, Sergesketter AR, Frakes MD, Lad SP. Error in trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. government site. concluded that the robot-assisted technique was significantly more accurate than the traditional freehand technique.39 Despite the learning curve and initial cost of obtaining technologies such as 3D fluoroscopic devices, intraoperative CT, or robotic navigational systems, the routine use of these technologies for intraoperative imaging confirmation and potential revision of misplaced screws may help spine surgeons avoid inadvertent iatrogenic morbidity for their patients and potential litigation. Presse Med 78:14471448, 1970. This decision must be made on a case-by-case basis at the surgeons and patients discretion after a thorough discussion of the associated risks and benefits of revision surgery. Forty-seven intraoperative and medical complications were observed in 41 patients (36.6%). NCI CPTC Antibody Characterization Program. Twenty-one patients (18.8%) had thoracolumbar injuries, and loss of immediate postoperative deformity correction ranged from 1.4 to 4.5. The median time to case closure was 56.3 (35.267.2) months when ruled in favor of the plaintiff (i.e., patient) compared to 61.5 (51.477.2) months for defendant (surgeon) verdicts (p = 0.117). 3). Despite these failures, solid spinal arthrodesis was obtained in all patients. Two patients with associated injuries in the lower limbs had deep venous thrombosis develop, three patients had pneumonia develop, and four patients with neurologic impairment had urinary tract infections develop. (PDF) Lumbosacral pedicle screw placement using a fluoroscopic pedicle Nahed BV, Babu MA, Smith TR, Heary RF. Intraoperative and postoperative complications were recorded by the authors and the results were evaluated by an independent observer. This device was used with an early version of the Cotrel-Dubousset instrumentation to provide sacral fixation and it is rarely used since the more widespread use of newer spine fixation systems. Accuracy and workflow of navigated spinal instrumentation with the mobile AIRO CT scanner. 2011;365(7):629636. Can Postoperative Radiographs Accurately Identify Screw Misplacements? Clin Orthop 227:1023, 1988. Screws penetrating the anterior cortex and abutting vascular structures, particularly aortic abutment with left-sided screws, which can lead to erosion and pseudoaneurysms. Defensive medicine in neurosurgery: the Canadian experience. Spine (Phila Pa 1976). 32. Author links open overlay panel Mohamad Bydon a b 1, Dimitrios Mathios a b 1, Mohamed Macki a b, Rafael De la Garza-Ramos a b, Nafi Aygun c, Daniel M. Sciubba a, Timothy F. Witham a, Ziya L. Gokaslan a b, Ali Bydon a b, Jean-Paul Wolinksy a. To evaluate the accuracy of pedicle screw placement using a novel classification system to determine potentially significant screw misplacement. Statistical analysis: Sankey. JAMA Intern Med. Neurological outcome and management of pedicle screws - PubMed I won't be at the office but I will check my voice mail. demonstrated that the number of hospital discharges for spinal fusion increased 2.4 times (137%) from 174,223 to 413,171 (p < 0.001) between 1998 and 2008.32 The true frequency of malpositioned pedicle and lateral mass screws is likely underestimated in spine surgery given the fact that the majority of misplaced screws, as well as the potential complications related to them, are not reported in practice and may be clinically silent. St Louis, CV Mosby 322327, 1987. Guzek RH, Mitchell SL, Krakow AR, Harshavardhana NS, Sarkissian EJ, Flynn JM.