pedicle screw misplacement malpractice

Once the spine is exposed, the appropriate levels of fixation are confirmed with the image intensifier. Deyo RA, Mirza SK, Martin BI. 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. 4. 19. Clin Orthop 203:7598, 1986. Ultimately, additional prospective, multiinstitutional large-volume studies are needed to validate these findings, and future studies should evaluate the long-term impact on the routine use of intraoperative imaging confirmation and/or computer- or robot-assisted navigation on the frequency and success of malpractice claims related to misplaced pedicle and lateral mass screws. 4). Pedicle screw | definition of pedicle screw by Medical dictionary Med Econ. 11. The patient had to undergo a subsequent surgery to remove the pedicles. Axial lumbar CT scans demonstrating both laterally (right) and medially (left) misplaced pedicle screws, resulting in pedicle and transverse process fractures (A) and canal compromise (A and B). Spinal fusion in the United States: analysis of trends from 1998 to 2008. (A) Anteroposterior and (B) lateral radiographs taken 2 years after surgery show unilateral pseudarthrosis in a 55-year-old man with spinal stenosis. Copyright © 2023 Becker's Healthcare. Harris RI, Wiley JJ: Acquired spondylolysis as a sequel to spine fusion. Malpractice litigation following spine surgery. 16,24,28 Simultaneously, the evolution of the surgical techniques has led to increased procedural safety. The purpose of current study was to analyze the complications and problems during and after pedicle screw fixation for various spinal disorders and trauma. J Neurosurg Spine. Spine 16:576579, 1991. Risk factor analysis showed smaller Cobb angles increased likelihood of all screws being AP. This demonstrates technical ability but does not represent the impact of screw misplacement on individual patients. Pedicle screw placement: Robotic assistance for greater precision 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. 5. Kreisman Law Offices has been handling Illinois surgical error lawsuits for individuals and families for more than 35 years in and around Chicago, Cook County and surrounding areas, including Batavia, Bellwood, Deerfield, Evanston, Franklin Park, and Lansing. 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. 2012;21(suppl 2):S196S199. 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. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Unable to load your collection due to an error, Unable to load your delegates due to an error. The site is secure. PLoS One. A.J. Li HM, Zhang RJ, Shen CL. Ann Thorac Surg. The total number of reoperations for MPS and patient clinical data were obtained from medical records at each hospital. Cases involving wrong-level or -side surgery, implant malfunction, or other misplaced spinal instrumentation (e.g., interbody cases, rods, surgical instruments, etc.) In our opinion, these problems may be prevented by applying the following principles: limitation of spine arthrodesis to the pathologic levels, inclusion of already extensive changes at the level above or below the planned arthrodesis into the arthrodesis, restoration of postoperative sagittal and coronal alignment, and avoidance of impingement syndrome from the adjacent nonfused facets. This study revealed an overall accuracy rate of 95.2% of mainly percutaneously inserted pedicle screws according to the classification of Zdichavsky et al. Notwithstanding these concessions, the MDU argued that misplacement of pedicle screw tracts was common in surgery of this kind, even in experienced and competent hands. Patient Suffers Permanent Nerve Damage From Spinal Surgery 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). Roy-Camille R, Saillant G, Mazel C: Internal fixation of the lumbar spine with pedicle screw plating. Dr. Friedlander did not order a CT or MRI until January 2013, when the pedicle screw was found to be in the wrong location and a failed fusion was diagnosed, according to the suit. 2021 Jul 1;41(Suppl 1):S80-S86. Insuring spinal neurosurgery. JAMA Intern Med. Misplacement of Pedicle Screws Leads to Years of Pain and Opioid Addiction Nationally Recognized Regionally Dominant Contact Us Now For a Free Consultation Over $850 Million in Verdicts and Settlements Home Articles Misplacement of Pedicle Screws Leads to Years of Pain and Opioid Addiction Despite these failures, solid spinal arthrodesis was obtained in all patients. In their meta-analysis of nine randomized controlled trials, Li et al. Neurologic injury. Continued clinical experience with various pedicle screw implant systems has led to ongoing improvements in system design to minimize implant failure rates and to improve ease of system application. Spine 8:970981, 1996. The development of the transpedicle screw has provided control of the vertebral motion segment in each plane, resisting any type of load. 5-7 Materials and Methods This is a retrospective study of kyphotic spondylitis tuberculosis (Stb) patients conducted at Fatmawati General Hospital, Jakarta, Indonesia, through the year 2020-2021. Patient safety: disclosure of medical errors and risk mitigation. In addition, the median time to judgment is substantial, particularly for defendant verdicts, spanning over 4.5 years from the time of surgery. However, the impact of robotic-assisted spinal fusion on patient outcomes is less clear. 2014;174(11):18671868. Steffee AD, Brantigan JW: The variable screw placement spinal fixation system: Report of a prospective study of 250 patients enrolled in Food and Drug Administration clinical trials. 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. Epub 2021 Aug 28. Potential complications may include increased pain, infection, or mechanical . All Rights Reserved. However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. Level of evidence: J Bone Joint Surg 45A:11591170, 1963. However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. Wolters Kluwer Health The rate of reoperation for screw misplacement per screw was 0.17%. doi: 10.1097/BRS.0b013e31822a2e0a. pedicle screw misplacement malpractice. J Pediatr Orthop. Epstein NE. The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. It is an effective procedure in that it provides an almost immediate stabilization of the spine [ 2-5 ]. In the remaining patients, the standard construct was three-segment fixation spanning four vertebrae and three discs, two above and one below the fractured vertebra, using six screws. We avoid using sharp automated drilling, and probe fully the pedicle cavity to prevent nerve root impairment. Schatlo B, Molliqaj G, Cuvinciuc V, et al. Gertzbein SD, Robbins SE: Accuracy of pedicular screw placement in vivo. Re: malpositioned pedicle screw resulting in additional surgery and disability. Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. Each case was then carefully screened for relevance and sufficient data. $ = US$; MW = Midwest; NE = Northeast; SE = Southeast; SW = Southwest; W = West. However, this difference was no longer significant when adjusted for inflation ($1,016,000 $90,875 vs $1,630,000 $422,405, p = 0.09). 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. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. A total of 69 patients (mean age, 67.416 . 4. Thus, we are unable to comment on whether all misplaced screws, particularly when asymptomatic, should be revised in an effort to prevent litigation. 6. Accuracy of C2 pedicle screw placement using the anatomic freehand technique. 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). Methods. Pedicle screw fixation is an effective but demanding method to treat various spinal disorders and is associated with a significant complication rate. 2011;365(7):629636. Spine (Phila Pa 1976). official website and that any information you provide is encrypted Recently, robot-assisted pedicle screw implantation has been increasingly utilized at large-volume academic centers. 22. Accuracy of C2 pedicle screw placement using the anatomic freehand Defensive medicine: a culprit in spiking healthcare costs. 6 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. Call me tomorrow. Nayar G, Blizzard DJ, Wang TY, et al. N Engl J Med. Twenty-one patients (18.8%) had thoracolumbar injuries, and loss of immediate postoperative deformity correction ranged from 1.4 to 4.5. 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. Clin Orthop 284:8090, 1992. Clipboard, Search History, and several other advanced features are temporarily unavailable. Unfortunately, the plaintiffs attorney was unable to offer an alternative theory of surgical negligence that would refute the defendants explanation. Dalenberg DD, Asher MA, Robinson RG, Jayaraman G: The effect of a stiff spinal implant and its loosening on bone mineral content in canines. 34. Cerebrospinal fluid fistulas. Am J Transl Res. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. In the current study, only five patients with junction problems above the instrumented area were observed with the following probable predisposing factors: an already degenerative disc, coronal imbalance, very long arthrodesis, and old age. Balch CM, Oreskovich MR, Dyrbye LN, et al. Taylor CL. Illinois Jury Finds in Favor of Doctor in Gallbladder Surgery that Led to Fatal Bowel Perforation Nickl v. Barry S. Rosen, M.D. Reprint requests to Pavlos Katonis, MD, 99 Minoos & Thenon Street, 71305, Heraklion, Crete, Greece. Conversely, Nyquists foot drop did not resolve after the screw was removed, which begged the question of whether the foot drop was in fact caused by the misplaced screw. 23. J Bone Joint Surg 54A:11951204, 1972. (PDF) Lumbosacral pedicle screw placement using a fluoroscopic pedicle Screw misplacement. Hardware-related failures were observed in 12 patients (10.7%). As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiffs spine. 2014;75(6):609613. Todd NV. Luque ER: Segmental spinal instrumentation of lumbar spine. Complications and Problems Related to Pedicle Screw Fixation - LWW Schlegel JD, Smith JA, Schleusener RN: Lumbar motion segment pathology adjacent to thoracolumbar, lumbar, and lumbosacral fusions. Rev Chir Orthop Reparatrice Appar Mot 62:151160, 1976. 5 Those authors recommend that particular care should be taken in inserting the washers without cross threading and ensuring that they are locked down tightly, with an adequate length of rod protruding beyond the screw. Stauffer RN, Coventry MB: Posterolateral lumbar-spine fusion: Analysis of the Mayo clinic series. You are talking one of the most complicated area of the law. St Louis, CV Mosby 322327, 1987. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement In unstable injuries, the segments above and below the level of injury may have a different orientation of the pedicle trajectory due to . Importantly, these advanced technologies are not always readily available or the standard of care and cannot supplant a thorough understanding of operative anatomy, a high-quality surgical technique, and general complication-avoidance measures. 2011;24(1):1519. 2012 Feb 1;37(3):E188-94. JAMA. Are We Underestimating the Significance of Pedicle Screw Misplacement Neurosurgery. 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. Zdeblick TA: A prospective randomized study of lumbar fusion: Preliminary results. However, the misplacement of pedicle screws can lead to disastrous complications. Spine 17:349355, 1992. 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. Pullout performance comparison of pedicle screws based on cement Litigation resulted in average payouts of $1,204,422 $753,832 between 1995 and 2019, when adjusted for inflation. Sethi MK, Obremskey WT, Natividad H, et al. Malpractice issues in neurological surgery. Pedicle screw placement accuracy using ultra-low radiation imaging with image enhancement versus conventional fluoroscopy in minimally invasive transforaminal lumbar interbody fusion: an internally randomized controlled trial. Routine CT scans were taken in all patients. Pedicle screw placement accuracy impact and comparison between grading 17. 20th Annual Spine, Orthopedic & Pain Management-Driven ASC Conference, 8th Annual Health IT + Digital Health + RCM Conference, 29th Annual Meeting - The Business & Operations of ASCs, The issues spine surgeons are advocating for outside of the operating room, Centinel Spine is now covered by all major payers, What's next for SI joint fusion? Start; O firmie; Usugi; Serwis; Realizacje i porady; Kontakt 2009;10(1):3339. Before Open lumbar pedicle screw technique - Operative Neurosurgery 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. 2. Melissa Nyquist required a lumbar back fusion for a herniated disc at the L4-5 level. Presse Med 78:14471448, 1970. 144 Pedicle screw insertion in the thoracolumbar spine. Clin Orthop 203:4553, 1986. Misplacement of Pedicle Screws Leads to Years of Pain and Opioid Addiction Misplacement rates have been reported to be from 5 to 41% in the lumbar spine and from 3 to 55% in the . 2018;41(5):e615e620. 15. Koktekir E, Ceylan D, Tatarli N, Karabagli H, Recber F, Akdemir G. Spine J. To investigate intraoperative reinsertion of percutaneous pedicle screw (PPS) with intraoperative CT-based navigation and to evaluate the rate of deviation of PPS at postoperative radiographic examination. Intraoperative and postoperative complications were recorded by the authors and the results were evaluated by an independent observer. I won't be at the office but I will check my voice mail. To prevent general complications, it is evident that precise and careful soft tissue handling, proper irrigation, and debridement during and after surgery, decrease of operative time, and proper patient monitoring postoperatively must be done. Brodsky AE: Post-laminectomy and post-fusion stenosis of the lumbar spine. 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. All of these patients were asymptomatic and had satisfactory final clinical outcomes (Fig 2). Grubb SA, Lipscomb HJ: Results of lumbosacral fusion for degenerative disc disease with and without instrumentation: Two- to five-year follow-up. Neurosurgical practice liability: relative risk by procedure type. Two-dimensional (2D) fluoroscopy-guided percutaneous pedicle screw (PPS) placement is currently the most widely applied instrumentation for minimally invasive treatment of spinal injuries requiring stabilization. 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. 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. 2020;11:38. Spine 6:263267, 1981. Please enable scripts and reload this page. 15. In addition, seven (6.3%) dural tears occurred during the decompression and none occurred during instrumentation. However, the highest offer had been a combined $300,000 from the two defendants. Quraishi NA, Hammett TC, Todd DB, et al. * Plaintiff's expert was prepared to testify at trial that these complaints are characteristic of a malpositioned screw impinging upon a neural structure. Malpractice claims in spine surgery in Germany: a 5-year analysis. One hundred four of the 112 patients had a posterior procedure. 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. 2020;45(2):E111E119. 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. 1,12,19,22 The largest series of adjacent segment breakdown was reported by Schlegel et al. Please try again soon. None of these complications resulted in additional surgery or in a significant increase of morbidity. 2012;41(2):6973. Risk Factors for the Drift Phenomenon in Oarm NavigationAssisted 14. Defensive medicine in U.S. spine neurosurgery. Examples of both laterally and medially misplaced lumbar pedicle screws are provided in Fig. Fager CA. Spine 6:615619, 1981. These complications may have resulted from powerful bending movement acting on the screw at its entry point to the bone. A rod is used to hold the vertebra together to allow fusion to occur. McLaughlin WM, Donnelley CA, Yu K, Gillinov SM, Tuason DA. 25. Comparison of pedicle screw placement accuracy between two types of Smith TR, Hulou MM, Yan SC, et al. J Neurosurg Spine. Rajaee SS, Bae HW, Kanim LE, Delamarter RB. 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. A misplacement rate of more than 20 % (129 misplaced screws out of 608) seems to be unacceptable compared to only 4.5 % misplacements when using CT-navigation leading to the conclusion that pedicle screw instrumentation in the middle and upper thoracic area should be carried out with the help of navigation only. The majority of plaintiffs were male (n = 44, 64.7%), and the median age among all cases was 46 years (range 3757 years). Both issues represent the most frequent and highest payouts in spine malpractice claims.10,14,22 While several studies have explored many of the factors related to malpractice claims in spine surgery, the medicolegal impact of misplaced pedicle and/or lateral mass screws has not been directly reported in the literature. Previous biomechanical and clinical studies defining junctional segment problems are lacking and consist mainly of case reports. It should be used by experienced and qualified surgeons who are familiar with the pitfalls associated with its use. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. There were two complete degenerations of the upper disc, one central canal stenosis, and two asymptomatic disc space narrowings and retrolistheses. 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 total of 2396 screws were placed accurately (87.96%). The medicolegal impact of misplaced pedicle and lateral mass screws on J Bone Joint Surg 61A:201207, 1979. The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. 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. 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. Eur Spine J. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? Several studies have shown that spine surgery is at the highest risk for litigation among the surgical subspecialties.12,29 The majority of claims are related to technical and procedural errors,29 including misplaced pedicle and/or lateral mass screws. Yuan et al 37 reported that the use of spinal instrumentation is associated with higher rate of infection (3%6%), neurologic injury (1%5%), instrumentation failure (6%10%), and reoperation (20%), compared with in situ arthrodeses. Saillant G: Etude anatomique des pedicules vertebraux: Application chirurgicale. Reviewed submitted version of manuscript: all authors. 26. Krag MH, Beynnon BD, Pope MH, et al: An internal fixator for posterior application to short segment of the thoracic, lumbar, or lumbosacral spine. The plaintiff underwent revision surgery in May 2013. Spine 24:23522357, 1999. Studdert DM, Mello MM, Sage WM, et al. Defensive medicine in neurosurgery: the Canadian experience. States were then grouped by US region and case year by 5-year intervals. 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. Disc space narrowing was the most common problem after instrumented arthrodesis and was observed in 27 patients (24.1%). Studies have shown that the greatest proportion of malpractice claims in spine surgery are related to procedural error,10,11,14,16,17,19 often resulting in the highest payouts.11,20 For spine surgery, one common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass screws, which occurs in approximately 14%55% of cases using standard techniques and results in neurological injury and/or durotomy in approximately 1%8% of cases.21 Misplaced screws have the potential to cause severe and sometimes permanent neurological deficits, including spinal cord and/or nerve root injury,21 as well as to decrease the stability of the fusion construct, leading to delayed complications related to pseudarthrosis. 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. 2013;123(9):20992103. All case demographics are summarized in Table 1. Likewise, cases are uploaded on a voluntary basis by state and federal judges and courts, which may lead to selection bias. You may be trying to access this site from a secured browser on the server. 33. Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). Phone/Fax: 30-2810-318361; E-mail: [emailprotected]. Using chi square analysis, statistically significant correlation was seen between disc space narrowing and loss of postoperative correction (p < 0.01). The accuracy rate of pedicle screw (PS) placement varies from 85% to 95% in the literature. The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. It is easier to confuse a jury than convince a judge: the crisis in medical malpractice. Thoracic Pedicle Screws - ScienceDirect Seabury SA, Chandra A, Lakdawalla DN, Jena AB. The aim of this study is to evaluate the accuracy of pedicle screw insertion in spondylitis tuberculosis kyphosis correction using a freehand technique. 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.

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