pedicle screw misplacement malpractice pedicle screw misplacement malpractice

Unfortunately, the plaintiffs attorney was unable to offer an alternative theory of surgical negligence that would refute the defendants explanation. Median screw misplacement rate was 10% in group A and 13% in group B. Percentage of cases per US region (center). 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. 2012 Feb 1;37(3):E188-94. The screws were needed to stabilize the spine and fix the fused vertebrae in place. J Neurosurg Spine. 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. The development of the transpedicle screw has provided control of the vertebral motion segment in each plane, resisting any type of load. Spine 24:23522357, 1999. 36. 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. 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). Categorical and continuous data are described as frequency (percentage) and median (interquartile range), respectively, except for the use of mean standard deviation for award amounts since both nominal and inflation-adjusted award totals passed (alpha = 0.05) the DAgostino-Pearson omnibus normality test. States were then grouped by US region and case year by 5-year intervals. . McLaughlin WM, Donnelley CA, Yu K, Gillinov SM, Tuason DA. Methods: After the removal of duplicates, a total of 68 unique cases met our inclusion criteria and were included for analysis. However, the misplacement of pedicle screws can lead to disastrous complications because of the close proximity to neural tissue and the surrounding vessels, although rare, serious complications have been reported, such as dural tear, nerve-root irritation, neural injury . 15. 2018;27(9):23392347. Copyright 1944-2023 American Association of Neurological Surgeons, Copy this link, or click below to email it to a friend. Pedicle screws have been used to treat spinal disorders, including those caused by spinal cancer, congenital anomalies, trauma, and chronic pain syndromes. Two patients had early postoperative postural headache that disappeared after removal of the misplaced screw. 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. All the incidental dural tears were repaired immediately and produced no clinical sequelae. Call Us Now For a Free Consultation | Toll Free: 800.583.8002 | Local: 312.346.0045, Cook County Surgeons Cut Common BIle Duct During Surgery, But Jury Finds for Defendants , Illinois Jury Finds in Favor of Doctor in Gallbladder Surgery that Led to Fatal Bowel Perforation , Debate Over Extent of Eye Damage Following Implant Lens Surgery Leads to $1 Million Verdict in, $75 Million Jury Verdict in Failure to Timely Diagnose Stroke, $18 Million Jury Verdict in Late Diagnosis of Breast Cancer, $300,000 Settlement for Excessive Use of Radiation, Chicago Medical Malpractice Lawyer Kreisman Law Offices Home, Contact Illinois Personal Injury Attorney Kreisman Law Offices. sharing sensitive information, make sure youre on a federal Both of these patients complained of thigh pain but refused any additional surgery. McAfee PC, Weiland DJ, Carlow JJ: Survivorship analysis of pedicle spinal instrumentation. The cost of defensive medicine on 3 hospital medicine services. There were nine instrumentation failures at the thoracolumbar area (seven patients), lumbar area (one patient), and lumbosacral area (one patient). Surg Neurol. 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. 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. reported that 69.3% of neurosurgeons who responded to their survey saw every patient as a potential lawsuit.1. 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. Scarone P, Vincenzo G, Distefano D, et al. 2017 Mar;5(2):109-116. doi: 10.1016/j.jspd.2016.10.007. Drafting the article: Sankey. 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. 2006;65(4):416421. These complications may have resulted from powerful bending movement acting on the screw at its entry point to the bone. 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). Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. Junctional problems were recorded as pathologic changes of the adjacent motion segments, just above and below the instrumented and fused segments. In 2 patients, misplacement of pedicle screws was recognized intraoperatively and all implants were removed. Mohar J, Vali M, Podovovnik E, Mihali R. Eur Spine J. The screws were needed to stabilize the spine and fix the fused vertebrae in place. Clipboard, Search History, and several other advanced features are temporarily unavailable. Zdeblick 38 also reported an overall arthrodesis rate of 65% in patients without instrumentation, 77% in patients with semirigid fixation, and 95% in patients with a rigid constrained screw-rod system. J Bone Joint Surg 54A:11951204, 1972. Lawsuit information regarding the plaintiffs age at the time of the malpractice claim, sex, postoperative complaint, indication for index surgery, defendant surgeon specialty (neurosurgery vs orthopedics), and delayed diagnosis or treatment, as well as case location by state and case year, was obtained. 38. 2021 Nov;9(6):1541-1548. doi: 10.1007/s43390-021-00377-5. 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. In unstable injuries, the segments above and below the level of injury may have a different orientation of the pedicle trajectory due to . A TLIF is a surgical procedure that attempts to fuse vertebrae in order to stabilize the patient's spine. Guzek RH, Mitchell SL, Krakow AR, Harshavardhana NS, Sarkissian EJ, Flynn JM. 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. We avoid using sharp automated drilling, and probe fully the pedicle cavity to prevent nerve root impairment. Disclosures Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. Before The last two patients had a T12L1 fracture-dislocation and a L4L5 spondylolytic spondylolisthesis at the site of plug dislodgments. 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. Pediatric pedicle screw placement using intraoperative computed tomography and 3-dimensional image-guided navigation. 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. Spine 6:615619, 1981. Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. A total of 2724 screws were placed in 127 patients. These numbers are in line with the current literature. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. 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. 2018;43(14):984990. Facebook Google Plus Youtube RSS Email. Using chi square analysis, statistically significant correlation was seen between disc space narrowing and loss of postoperative correction (p < 0.01). A p < 0.05 was considered statistically significant. Spine neurosurgeons facing the judicialization of their profession: disenchantment and alteration of daily practicea qualitative study. Start; O firmie; Usugi; Serwis; Realizacje i porady; Kontakt Complete degeneration of the upper disc developed in two patients who had spinal stenosis and degenerative scoliosis. Accuracy of C2 pedicle screw placement using the anatomic freehand technique. 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. 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. Harrington and Tullos 11 first reported the technique of transpedicle screw fixation, and Roy-Camille et al 23 popularized the first practical method of pedicle screw fixation. Svider PF, Kovalerchik O, Mauro AC, et al. 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. Jury awards $4.5M over misplaced pedicle screw during spine surgery: 5 things to know Spine Monday, May 7th, 2018 Post Listen Text Size On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. Instead, the defense offered up an alternative explanation for Nyquists foot drop. 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. Study design: What can spine surgeons do to improve patient care and avoid medical negligence suits? 18. Placement of the pedicle screws in the thoracolumbar and lumbar spine is a technically demanding procedure. Despite this problem, the clinical result was excellent. Several limitations should be carefully considered when interpreting our results. However, published reports are increasingly demonstrative of the positive effect of pedicle fixation on arthrodesis and successful outcome in the treatment of patients with these disorders. However, this is the first study to evaluate the direct medicolegal impact of misplaced pedicle and lateral mass screws on spine surgery in the US and presents important information that may support the routine use of intraoperative imaging confirmation (via 3D fluoroscopy or intraoperative CT) and/or navigated screw placement (either computer- or robot-assisted) as a potential method to decrease the risk of future litigation during spinal fusion procedures. 3,4,9,29,34 In addition, developments in surgical technique and implant design have decreased operative risk and implant-related complications. The third surgical procedure removed the pedicle screws but left the patient in an unfused state with an unstable spine. To reinforce spinal fixation, we have proposed a construct with segmental pedicle fixation two levels above and one level below the injured level and insertion of a screw deep into the pedicle, providing more contact area between screw head and bone and reducing the moment arm of the bending stress. Friedlander and Bradley will pay half of the $2.25 million. 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%. J Bone Joint Surg 45A:11591170, 1963. 23. 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). Seabury SA, Chandra A, Lakdawalla DN, Jena AB. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiff's spine. Spine 16(8 Suppl):S422427, 1991. 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. In addition, seven (6.3%) dural tears occurred during the decompression and none occurred during instrumentation. Your message has been successfully sent to your colleague. Clin Orthop 284:8090, 1992. Would you like email updates of new search results? 26. 2019;19(7):12211231. Studdert DM, Mello MM, Sage WM, et al. Spine (Phila Pa 1976). 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 The plaintiff will recover $2.25 million because of a high-low agreement the lawyers entered after closing arguments, the New Jersey Law Journal reports. N Engl J Med. doi: 10.1097/BRS.0b013e31822a2e0a. 8. 16. General complications were considered those developing during and after surgery that were not directly related to instrumentation. A total of 69 patients (mean age, 67.416 . 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. 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. Sarwahi V, Ayan S, Amaral T, Wendolowski S, Gecelter R, Lo Y, Thornhill B. Spine Deform. Comparetto, Esq., 727-328-7900, www.florida-malpractice-lawyers.com. Please do not include any confidential or sensitive information in a contact form, text message, or voicemail. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Linking and Reprinting Policy. The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. Excessive hemorrhage occurred in two patients (1.8%) with coagulation disorders. However, the misplacement of pedicle screws can lead to disastrous complications. J Neurosurg Spine. 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. All the operations were done by one surgeon (PK). Spine 16(8 Suppl):S455458, 1991. Please try after some time. The amount awarded was not significantly different across US regions (p = 0.9; Fig. The aim of this study is to evaluate the accuracy of pedicle screw insertion in spondylitis tuberculosis kyphosis correction using a freehand technique. Spine 16:576579, 1991. PLoS One. Breakage of a divergent screw of a Chopin block at the lumbosacral area was seen 3 months after surgery. Eur Spine J. A retrospective review of charts, x-rays (XRs) and computed tomography (CT) scans was performed. Drs. J Neurosurg. 1,12,19,22 The largest series of adjacent segment breakdown was reported by Schlegel et al. 13. 4). Two patients had an acute infection develop for which they required operative intervention with irrigation and debridement. Plaintiff-awarded cases by US region (left). The purpose of current study was to analyze the complications and problems during and after pedicle screw fixation for various spinal disorders and trauma. To evaluate the accuracy of pedicle screw placement using a novel classification system to determine potentially significant screw misplacement. 1. 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. Spine 13:696706, 1988. The median time to case closure was longer for defendant-awarded cases, but this finding was not statistically significant (61.5 vs 56.3 months, p > 0.05). 2017;42(3):177185. 17,18,31,39 Edwards 6 showed that solid arthrodesis developed in 96% of patients without previous surgery, whereas 84% of patients having secondary operations experienced a similar result. Achieving proper lumbar lordosis, evaluating any preexisting scoliosis, and intraoperative assessment with AP radiographs could prevent balance problems. 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. The link was not copied. 7. George Sapkas, MD, DSc; and Panayiotis J. Papagelopoulis, MD, DScGuest Editors. Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. 2002;27(22):24252430. Luque ER: Segmental spinal instrumentation of lumbar spine. 26 They support that after a lengthy symptom-free period, segments next to a fused segment can break down and the segment next to the adjacent segment is almost as likely to break down as the adjacent segment. Epub 2021 Aug 28. J Neurosurg Spine. 2017;27(4):470475. J Bone Joint Surg 61A:201207, 1979. 10. 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. Wolters Kluwer Health 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. Except for two patients with spinal metastatic disease, all other patients received an iliac crest autologous bone grafts. All Rights Reserved. (%), Pseudarthrosis requiring revision surgery. 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. Intraoperative pedicle fractures requiring further points of fixation. Hecht N, Kamphuis M, Czabanka M, et al. Spine J. Orthop Trans 11:99, 1987. Epub 2022 Oct 29. I won't be at the office but I will check my voice mail. 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). 6. Bethesda, MD 20894, Web Policies 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. Arthrodesis was questionable in eight asymptomatic patients (7.1%). Despite commonly used, questions remain about their safety especially for the thoracic spine and in deformity where difficulty in positioning can lead to pedicle breach and adjacent structures injury. (A) Anteroposterior and (B) lateral radiographs taken 2 years after surgery show unilateral pseudarthrosis in a 55-year-old man with spinal stenosis. Spinal fusion procedures are increasingly performed each year, with Deyo et al. Illinois Jury Finds in Favor of Doctor in Gallbladder Surgery that Led to Fatal Bowel Perforation Nickl v. Barry S. Rosen, M.D. Patient safety: disclosure of medical errors and risk mitigation. Malpractice risk according to physician specialty. Morphometric analysis of the proximal thoracic pedicles in Lenke II and IV adolescent idiopathic scoliosis: an evaluation of the feasibility for pedicle screw insertion. 1 Although this technique has advantages over open instrumentation, it also presents new challenges and specific complications. Feb. 16, 2021 Accurate placement of pedicle screws is key to avoiding the potential complications of spinal fusion surgery and improving overall spinal fixation. In situ spine arthrodesis permits load sharing by the vertebral bodies, preventing fatigue failure of the implant. Weinstein JN, Spratt KF, Spengler D, Brick C, Reid S: Spinal pedicle fixation: Reliability and validity of roentgenogram-based assessment and surgical factors on successful screw placement. The majority of screws were misplaced in the lumbar spine for both plaintiff- and defendant-awarded cases (66.7% vs 57.4%, respectively, p = 0.564; Table 1). 1 To be effective, the pedicle screw constructs must withstand intraoperative loading and physiological forces due to daily postoperative activities. 2020;162(6):13791387. 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. However, the misplacement of pedicle screws can lead to disastrous complications. Todd NV. 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. 2016;124(5):15241530. Fager CA. Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. Show more. Malpractice claims in spine surgery in Germany: a 5-year analysis. Balch CM, Oreskovich MR, Dyrbye LN, et al. Introduction. Spine arthrodesis was evaluated with plain AP and lateral radiographs taken 1 year after surgery. Dr. Abd-El-Barr is a consultant for Spineology. Johnston II CE, Ashman RB, Baird AM, Allard RN: Effect of spinal construct stiffness on early fusion mass incorporation: Experimental study. EOS System Courtesy of EOS imaging. The instrumentation and bone graft were left in place in these patients (total infection rate, 2.7%). 3. Pedicle screws are used by spine surgeons as part of a fusion in which two adjacent bones in the spine are combined together as one. However, the highest offer had been a combined $300,000 from the two defendants. Waddell G, Kummell EG, Lotto WN, et al: Failed lumbar disc surgery and repeat surgery following industrial injuries. Grubb SA, Lipscomb HJ: Results of lumbosacral fusion for degenerative disc disease with and without instrumentation: Two- to five-year follow-up. 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. This step in implant evolution was inevitable, because prior phases of implant development did not control each plane of motion segment stress. J Neurosurg Spine. 2018;18(2):209215. Methods. Br J Neurosurg. 2014;75(6):609613. J Spinal Disord Tech. Data is temporarily unavailable. Neurosurgical practice liability: relative risk by procedure type. and 17.1% of the patients included had at least one screw misplaced. * Am J Orthop. Screw misplacement. 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. 2021 Nov 26;22(1):986. doi: 10.1186/s12891-021-04860-y. Bydon M, Xu R, Amin AG, Macki M, Kaloostian P, Sciubba DM, Wolinsky JP, Bydon A, Gokaslan ZL, Witham TF. In the current study, no incidence of bent and broken screws or tulip screw plug dislodgement necessitated additional treatment, and all the patients achieved solid fusion despite the failure of instrumentation. The states with the most cases included California (n = 10, 14.7%), New York (n = 6, 8.8%), Pennsylvania (n = 6, 8.8%), and Illinois (n = 5, 7.3%; Table 2). Makhni MC, Park PJ, Jimenez J, et al. Epub 2014 Apr 4. Inaccurate pedicle screw placement is relatively common even when placement is performed under fluoroscopic control. J Spine Surg. Personal consequences of malpractice lawsuits on American surgeons. Abstract BACKGROUND CONTEXT Surgeons have increasingly adopted robotic-assisted lumbar spinal fusion due to indications that robotic-assisted surgery can reduce pedicle screw misplacement. Some error has occurred while processing your request.