Thus, in the current study we aimed to describe this impact in the US, as well as to suggest a potential method for mitigating the problem. What can spine surgeons do to improve patient care and avoid medical negligence suits? 4. Eur Spine J. The suit claimed Dr. Friedlander failed to diagnose and treat the mispositioned screw in a timely manner, leading the plaintiff to develop pain in his right leg, numbness in his right calf and weakness in his right toes. reporting that the number of Medicare patients who underwent a complex lumbar spine fusion for spinal stenosis increased 15-fold, from 1.3 persons per 100,000 Medicare persons in 2002 to 19.9 in 2007.31 Similarly, a study by Rajaee et al. Through the use of expert witness testimony, Mr. da Costa was able to prove to the jury that by misplacing the pedicle screw during the surgery, and failing to timely diagnose and correct the malpositioned screw, Defendants deviated from accepted standards of care. Methods: 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. Submitting a contact form, sending a text message, making a phone call, or leaving a voicemail does not create an attorney-client relationship. Fishers exact test and the Mann-Whitney U-test were used for the analysis of categorical and continuous data, respectively, except when an unpaired t-test was utilized for analyses related to normalized, nominal, and inflation-adjusted award totals. laterally placed screws and the azygous vein on the right (T5-T11). A.J. This demonstrates technical ability but does not represent the impact of screw misplacement on individual patients. The largest inflation-adjusted payout awarded to the plaintiff ($3,372,185) for nerve root injury occurred in a 36-year-old male who had undergone an L4S1 posterior spinal fusion, which resulted in permanent and direct injury to right L5 and S1 nerve roots, with foot drop and radiculopathy. Balch CM, Oreskovich MR, Dyrbye LN, et al. Per-patient analysis reveals more concerning numbers toward screw misplacement. In the other patient, L4L5 float arthrodesis was done. Epstein NE. 4. Most of these complications were minor and with the exception of two misplaced screws, did not contribute to the occurrence of neurologic impairment or severe pain. Screws penetrating the anterior cortex and abutting vascular structures, particularly aortic abutment with left-sided screws, which can lead to erosion and pseudoaneurysms. 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. Robotic-assisted pedicle screw placement fails to reduce overall 2021 Nov;9(6):1541-1548. doi: 10.1007/s43390-021-00377-5. 1. Call me tomorrow. 2014;75(6):609613. Din RS, Yan SC, Cote DJ, et al. 1,12,19,22 The largest series of adjacent segment breakdown was reported by Schlegel et al. leg pain. J Bone Joint Surg 73A:11791184, 1991. 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. Hardware-related failures were observed in 12 patients (10.7%). Med Econ. Debate Over Extent of Eye Damage Following Implant Lens Surgery Leads to $1 Million Verdict in Zaleski v Elmhurst Eye Surgery Center. Steffee AD, Biscup RS, Sitkowski DJ: Segmental spine plates with pedicle screw fixation: A new internal fixation device for disorders of the lumbar and thoracolumbar spine. Achieving proper lumbar lordosis, evaluating any preexisting scoliosis, and intraoperative assessment with AP radiographs could prevent balance problems. Arthrodesis was questionable in eight asymptomatic patients (7.1%). While the majority of claims are found to lack merit, resulting in a verdict in favor of the defendant or case dismissal,7,1316 at least 37% are considered valid.26 Regardless, payouts to plaintiffs are often substantial, averaging in the hundreds of thousands to millions of dollars in both the US and Europe.10,11,14,17,20 Communication of errors and expectations, thorough documentation, and selection of appropriate patients and surgical indications have been shown to reduce the likelihood of a successful malpractice claim.13,16,27,28 In addition, attempts at tort reform in some states have helped limit the financial burden of medical malpractice payouts through methods such as capitation.16,20,22,26 However, efforts to limit malpractice claims in the first place are greatly needed. Previous biomechanical and clinical studies defining junctional segment problems are lacking and consist mainly of case reports. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiffs spine. Risk factor analysis showed smaller Cobb angles increased likelihood of all screws being AP. Pedicle Screw Insertion in Spondylitis Tuberculosis | ORR 2011;213(5):657667. A retrospective review of charts, XRs and low-dose CT scans of 127 patients who underwent spinal fusion with pedicle screws for spinal deformity was performed. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement These complications may have resulted from powerful bending movement acting on the screw at its entry point to the bone. Procedural errors led to combined payouts totaling $124,943,933 in neurosurgery claims between 2003 and 2012 in a study looking at data from the Physician Insurers Association of America Data Sharing Project.10 However, our study is the first to report the direct medicolegal impact of screw misplacement on US spine surgery, with 30.9% of judgments/settlements in favor of the plaintiff, resulting in average payouts of $1,204,422 $753,832 per claim. Pedicle screw accuracy in thoracolumbar fractures- is routine postoperative CT scan necessary? Whitecloud III TS, Butler JC, Cohen JL, Candelora PD: Complications with the variable spinal plating system. Pedicle screw construct have become one of the most practiced procedure in spinal surgery. Accuracy of pedicle screw placement and clinical outcomes of robot-assisted technique versus conventional freehand technique in spine surgery from nine randomized controlled trials: a meta-analysis. However, the highest offer had been a combined $300,000 from the two defendants. This study has shown that percutaneous insertion of pedicle screws in the lumbar spine is a safe and reliable technique, and despite the low misplacement rate of only 6.6%, it should be kept in mind that the surgical procedure is technically demanding and should be performed only by experienced spine surgeons. 2020;162(6):13791387. J Spinal Disord Tech. Reoperation for Misplaced Pedicle Screws: A Multicenter Retrospec Pullout performance comparison of pedicle screws based on cement Percentage of cases per US region (center). CT-navigation versus fluoroscopy-guided placement of pedicle screws at Ann R Coll Surg Engl. 6 The defendants explanation provided an explanation for why Nyquists foot drop did not resolve after the misplaced screw was removed and shed doubt on the plaintiffs theory of liability. Neurological Outcome and Management of Pedicle Screws Misplaced Totally Study design: 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. Rather, the defense demonstrated that although the misplaced screw had in fact irritated the L4 nerve root for the six days before it was removed, the related symptoms resolved with the screws removal. J Neurosurg Spine. To prevent the development of pseudarthrosis, we think it is important for surgeons to apply the following five technical principles: the proper-sized pedicle screw has to be inserted on the first attempt; repeated manipulation in setting instruments must be avoided; anterior penetration of the screw into the sacrum and insertion of two screws in each side are advocated for fixing the lumbosacral junction; industrious and detailed decortication of the posterior elements must be developed fully; and the use of autologous bone graft is recommended. However, the defendant doctor maintained that Nyquists foot drop was not caused by the misplaced screw. J Neurosurg Spine. INCLUDE WHEN CITING DOI: 10.3171/2020.8.FOCUS20600. Adjusted for age and preoperative Cobb angle, patients with a higher misplacement rate were more likely to have screws . 2020;11:38. Koktekir E, Ceylan D, Tatarli N, Karabagli H, Recber F, Akdemir G. Spine J. $2 Million Spinal Surgery Case Against Neurosurgeon and Hospital 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. Hardware problems were those related to the physical change of metal and screw position. Pedicle screw instrumentation is widely used for the stabilization of the subaxial cervical, thoracic, and lumbar spine. The average age of the patients was 47 years and the average followup was 35 months. Malpractice issues in neurological surgery. Spine 13:696706, 1988. JAMA. However, 5-10% of those misplaced screws are cause for concern." "To rectify this, we must have access to imaging devices during the procedure. The intent is to provide relief from pain and nerve damage. 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. 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). St Louis, CV Mosby 322327, 1987. Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort. Ultimately, no significant differences were seen in inflation-adjusted award information between plaintiff and defendant (Table 3). Materials and Methods Sixty . 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. The site is secure. It should be used by experienced and qualified surgeons who are aware of the pitfalls associated with its use. Several limitations should be carefully considered when interpreting our results. Acquisition of data: Sankey. Despite these failures, solid spinal arthrodesis was obtained in all patients. One of the common means of doing so is to place a screw into each of two adjacent spinal bones (vertebrae), and then a rod between them. Waddell G, Kummell EG, Lotto WN, et al: Failed lumbar disc surgery and repeat surgery following industrial injuries. However, the misplacement of pedicle screws can lead to disastrous complications. Except for two patients with spinal metastatic disease, all other patients received an iliac crest autologous bone grafts. 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. Furthermore, 25 patients (22.3%) reported persistent pain in the iliac crest (donor graft site) for several months, for which they were treated with repeated lidocaine injections and analgesics. 8600 Rockville Pike 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. NCI CPTC Antibody Characterization Program. Spine 18:983991, 1993. J Neurosurg. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. shooting in valdosta leaves one dead reported that 69.3% of neurosurgeons who responded to their survey saw every patient as a potential lawsuit.1. Elsamadicy AA, Sergesketter AR, Frakes MD, Lad SP. 28. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement. It argued that the foot drop was unavoidable and due to the surgeons need to manipulate the right L5 nerve root in order to remove Nyquists herniated disc during the spinal fusion surgery. Can Postoperative Radiographs Accurately Identify Screw Misplacements? Department of Neurosurgery, Spine Division, Duke University Medical Center, Durham, North Carolina; and, Malpractice liability and defensive medicine: a national survey of neurosurgeons, Defensive medicine among high-risk specialist physicians in a volatile malpractice environment, Defensive medicine: a culprit in spiking healthcare costs, Incidence and costs of defensive medicine among orthopedic surgeons in the United States: a national survey study, Defensive medicine in U.S. spine neurosurgery, Personal consequences of malpractice lawsuits on American surgeons. Examples of both laterally and medially misplaced lumbar pedicle screws are provided in Fig. JAMA. Nahed BV, Babu MA, Smith TR, Heary RF. 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. On average, physicians spend nearly 11 percent of their 40-year careers with an open, unresolved malpractice claim. In six patients (5.3%) with degenerative spine disease, the disc material had been removed. 2018;28(2):186193. Crawford MJ, Esses SI: Indications for pedicle fixation: Results of NASS/SRS faculty questionnaire: North American Spine Society and Scoliosis Research Society. This site needs JavaScript to work properly. $ = US$; MW = Midwest; NE = Northeast; SE = Southeast; SW = Southwest; W = West. 70% of Pedicle Screws are misplaced - orthostreams.com Am J Orthop. 2. 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. Misplaced pedicle and lateral mass screws result in a considerable risk of malpractice litigation against spine surgeons. Pedicle screw | definition of pedicle screw by Medical dictionary In addition, studies have shown that over 85% of malpractice claims are either dismissed or settled out of court,14 which likely results in a high degree of underreporting. The plaintiff underwent revision surgery in May 2013. 38. All of these patients were asymptomatic and had satisfactory final clinical outcomes (Fig 2). Morphometric analysis of the proximal thoracic pedicles in Lenke II and IV adolescent idiopathic scoliosis: an evaluation of the feasibility for pedicle screw insertion. doi: 10.1097/BRS.0b013e31822a2e0a. Mississippi Appellate Court Affirms Medical Malpractice Defense Verdict Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. 16. Image intensification and the technique recommended by Weinstein et al 32 was used for screw placement in the lumbar vertebrae, whereas Chopin blocks (Medtronic Sofamor Danek) with two screws diverging bilaterally were used for sacral fixation. Bookshelf Please enable it to take advantage of the complete set of features! Pedicle Screw Malposition Expert Witness: Malposition Can Lead to Forty-seven general complications were seen in 41 patients (36.5%). The amount awarded was not significantly different across US regions (p = 0.9; Fig. Whitecloud et al 35 reported an overall 45% rate of minor and major complications, with the rate of complications increasing to 63% in patients who had previous lumbar surgery. Scarone P, Vincenzo G, Distefano D, et al. Conception and design: Sankey, KD Than. Cook County Surgeons Cut Common BIle Duct During Surgery, But Jury Finds for Defendants Irwin v. Alan Loren, M.D. First, this is a retrospective analysis of cases obtained from the web-based Westlaw Edge legal research database. It should be used by experienced and qualified surgeons who are familiar with the pitfalls associated with its use. 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. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). Characteristics of medicolegal cases related to misplaced screws in spine surgery. A total of 2396 screws were placed accurately (87.96%). (%), Pseudarthrosis requiring revision surgery. The authors of the current study aimed to describe this impact in the United States, as well as to suggest a potential method for mitigating the problem. West III JL, Bradford DS, Ogilvie JW: Complications of the variable screw pedicle screw fixation. (PDF) Accuracy of pedicle screw placement in the lumbosacral spine Surg Neurol Int. Objective: Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. All Rights Reserved. Descriptive analysis of state and federal spine surgery malpractice litigation in the United States. One hundred twelve patients were treated using the Cotrel-Dubousset pedicle screw fixation system for degenerative disease (57 patients), trauma (42 patients), infection (eight patients), and tumor (five patients) of the lumbar or thoracolumbar spine. Another possible cause was the high lateral torques to the entire frame that occurred during tightening of the tulip screw. Steinmann JC, Herkowitz HN: Pseudarthrosis of the spine. Please try after some time. 2018;41(5):e615e620. Likewise, research shows that breaches still occur when these tools are used,33,40 and some studies did not find a difference in pedicle breach rates compared to those with traditional fluoroscopic and freehand techniques.33 Ultimately, misplaced instrumentation is a risk of any spinal fusion surgery, and a thorough discussion of these risks, as well as the alternative management options, is essential to maintain high-quality patient care and to avoid litigation. J Neurosurg Spine. Although the rate of the reported medical complications was high (36.5%), these did not significantly affect the final clinical outcome of the current patients. 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. All the incidental dural tears were repaired immediately and produced no clinical sequelae. 2017 Mar;5(2):109-116. doi: 10.1016/j.jspd.2016.10.007. Gertzbein SD, Robbins SE: Accuracy of pedicular screw placement in vivo. Taylor CL. 25. Spine 16(8 Suppl):S422427, 1991. Illinois Jury Finds in Favor of Doctor in Gallbladder Surgery that Led to Fatal Bowel Perforation Nickl v. Barry S. Rosen, M.D. . Mayo Clinic uses the latest robot-assisted technology when indicated to enhance surgical precision in these procedures. However, the impact of robotic-assisted spinal fusion on patient outcomes is less clear. There were two complete degenerations of the upper disc, one central canal stenosis, and two asymptomatic disc space narrowings and retrolistheses. Pedicle screw placement is a common procedure. An official website of the United States government. J Spine Surg. Larson AN, Santos ER, Polly DW Jr, Ledonio CG, Sembrano JN, Mielke CH, Guidera KJ. Clin Orthop 203:7598, 1986. 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. Three slender patients complained of soft tissue irritation and a bothersome prominence because of the screws bulky profile. While reported to be one of the best legal research resources available and utilized in several previous studies,7,14,16,23,24 available court documents and clinical/operative details are highly variable and greatly limited among case files. 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. Feb. 16, 2021 Accurate placement of pedicle screws is key to avoiding the potential complications of spinal fusion surgery and improving overall spinal fixation. We also investigated the effect of bone mineral density (BMD), diameter of pedicle screws, and the region of spine on the pullout strength of pedicle screws. Per-patient analysis showed 23 (18.11%) of patients had all screws AP. Overall reported screw misplacement is low, but it does not reflect the potential impact on patient morbidity. Zucherman J, Hsu K, Picetti III G, et al: Clinical efficacy of spinal instrumentation in lumbar degenerative disc disease. Over 40% of patients had screws with either some/major concern. FOIA The cost of defensive medicine on 3 hospital medicine services. Would you like email updates of new search results? 2016;25(3):716723. Results: 0 attorneys agreed. It is easier to confuse a jury than convince a judge: the crisis in medical malpractice. Before may email you for journal alerts and information, but is committed Pedicle screw insertion in the thoracolumbar spine. Defendant-awarded cases by US region (right). In the Kane County medical malpractice lawsuit of Melissa Nyquist v. Dr. Taras Masnyk and DuPage Neurosurgery, S.C., 06 L 421, the plaintiffs attorney was unable to convince the jury that the plaintiffs medical complications were caused by the defendants negligence. The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. 2013;32(1):111119. Plaintiff award amounts were adjusted for inflation as of April 2020 using an online inflation calculator provided by the US Bureau of Labor Statistics (https://www.bls.gov/data/inflation_calculator.htm). Critically revising the article: all authors. Zdeblick TA: A prospective randomized study of lumbar fusion: Preliminary results. The instrumentation and bone graft were left in place in these patients (total infection rate, 2.7%). Clipboard, Search History, and several other advanced features are temporarily unavailable. 29. 15. However, the misplacement of pedicle screws can lead to disastrous complications. (PDF) Lumbosacral pedicle screw placement using a fluoroscopic pedicle 35. Pedicle screw insertion techniques: an update and review of the J Am Coll Surg. Clin Orthop 227:1023, 1988. Spine 17:349355, 1992. When grouped by US region, most cases occurred in the Northeast (n = 25, 36.8%), followed by the West (n = 15, 22.1%; Fig. (A) Anteroposterior and (B) lateral radiographs taken 1 year after surgery show upper screw breakage in the application of a short Cotrel-Dubousset construct in a T12 burst fracture. matte black square deadbolt; roberts point park fishing report; qr code on binax covid test; mff premium character list. Similarly, the highest inflation-adjusted amount awarded ($2,302,472) for pseudarthrosis was attributed to a medially breached pedicle screw during an L5S1 fusion that was determined to have caused the failed union and subsequent need for revision surgery. 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. The patient suffered permanent nerve damage as a result of the puncture. Spine (Phila Pa 1976). Pedicle instrumentation in the thoracolumbar and lumbar spine is a technically challenging procedure. Dr. Shaffrey holds patents with, receives royalties from, and is a consultant for Medtronic, NuVasive, and Zimmer Biomet; is a stockholder in NuVasive; is a consultant for K2M, Stryker, SI Bone, and In Vivo; and has received grants from the ISSG, DePuy Synthes, and AO Spine. The literature gave a range of screw misplacement rates detected on postoperative imaging of between 1% and 18%, with the rate generally considered to be around 10%. The rate of reoperation for screw misplacement per screw was 0.17%. Spine 18:11601172, 1993. Excessive hemorrhage occurred in two patients (1.8%) with coagulation disorders. Spine 8:970981, 1996. All Rights Reserved. Spine (Phila Pa 1976). The medicolegal impact of misplaced pedicle and lateral mass screws on 2014 Aug 1;14(8):1702-8. doi: 10.1016/j.spinee.2014.03.044. 2018;83(5):9971006. Back pain/spinal stenosis and neurogenic claudication/radiculopathy were the most frequently reported indications for the index surgery, accounting for 13 (19.1%) and 11 (16.2%) cases, respectively. Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison. Twenty-one patients (18.8%) had thoracolumbar injuries, and loss of immediate postoperative deformity correction ranged from 1.4 to 4.5. The incidence of screw failure, which can occur despite solid arthrodesis, 7 in the current series was 8% and mainly involved patients with thoracolumbar injury. 2. 2018;18(2):209215. 20 Tips to Avoid and Handle Problems in the Placement - ScienceDirect Although the rate of the reported complications was high, the final outcome of the patients was not affected significantly. The remaining eight patients, including two patients with spinal trauma, five patients with infection, and one patient with a tumor, had anterior and posterior procedures. In addition, the median time to judgment is substantial, particularly for defendant verdicts, spanning over 4.5 years from the time of surgery. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? Sethi MK, Obremskey WT, Natividad H, et al. 3. Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. 2020;45(2):E111E119. Statistical analysis: Sankey. The standard imaging technique for pedicle screw insertion is two-dimensional images obtained from C-arm-type X-ray fluoroscopy. 2021 Jul 1;41(Suppl 1):S80-S86. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. pedicle screw: A rigid surgical implant used to stabilize adjacent spinal segments in spinal fusion surgery. Clin Orthop 203:4553, 1986.

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