This site needs JavaScript to work properly. A total of 2724 screws were placed in 127 patients. Reviewed submitted version of manuscript: all authors. Zucherman J, Hsu K, Picetti III G, et al: Clinical efficacy of spinal instrumentation in lumbar degenerative disc disease. The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. PURPOSE This study aimed to compare rates of perioperative complications between robotic-assisted and conventional . 29. Jury awards $4.5M over misplaced pedicle screw during spine surgery: 5 Am J Transl Res. However, the highest offer had been a combined $300,000 from the two defendants. Epub 2021 Aug 28. 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. 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. 2018;27(9):23392347. Waddell G, Kummell EG, Lotto WN, et al: Failed lumbar disc surgery and repeat surgery following industrial injuries. 2012;21(suppl 2):S196S199. Breakage of a divergent screw of a Chopin block at the lumbosacral area was seen 3 months after surgery. Balch CM, Oreskovich MR, Dyrbye LN, et al. Show more. 8,24,25,32. Seabury SA, Chandra A, Lakdawalla DN, Jena AB. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). All the operations were done by one surgeon (PK). Cerebrospinal fluid fistulas. Orthopedics. Hsu K, Zucherman JF, White AH: Internal Fixation With Pedicle Screws. A total of 47 (69.1%) cases resulted in a decision for the defendant and 21 (30.9%) for the plaintiff. 1,12,19,22 The largest series of adjacent segment breakdown was reported by Schlegel et al. 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. 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. 2018;41(5):e615e620. J Bone Joint Surg 54A:11951204, 1972. single homes for sale in lehigh valley, pa your express consent. Copyright © 2023 Becker's Healthcare. Spinal fusion procedures are increasingly performed each year, with Deyo et al. 33. Pullout performance comparison of pedicle screws based on cement Drs. 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. Disc space narrowing was the most common problem after instrumented arthrodesis and was observed in 27 patients (24.1%). Pedicle screw insertion - AO Foundation Jena AB, Seabury S, Lakdawalla D, Chandra A. Elizabeth Hofheinz, M.P.H., M.Ed. Spine arthrodesis was evaluated with plain AP and lateral radiographs taken 1 year after surgery. Copyright 1944-2023 American Association of Neurological Surgeons, Copy this link, or click below to email it to a friend. 2 One of the first obstacles regarding . 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. Defensive medicine in U.S. spine neurosurgery. Debate Over Extent of Eye Damage Following Implant Lens Surgery Leads to $1 Million Verdict in Zaleski v Elmhurst Eye Surgery Center. This demonstrates technical ability but does not represent the impact of screw misplacement on individual patients. However, the impact of robotic-assisted spinal fusion on patient outcomes is less clear. 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. sharing sensitive information, make sure youre on a federal A total of 2396 screws were placed accurately (87.96%). Clin Orthop 115:130139, 1976. At the lumbosacral area, breakage of a divergent screw of a Chopin block occurred on only one side with no loss of correction. 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. 20. 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). Inaccurate pedicle screw placement is relatively common even when placement is performed under fluoroscopic control. J Neurosurg Spine. FOIA 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. Please enable scripts and reload this page. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. Cotrel Y, Dubousset J, Guillaumat M: New universal instrumentation in spinal surgery. 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. Pediatric pedicle screw placement using intraoperative computed tomography and 3-dimensional image-guided navigation. Nominal and inflation-adjusted award payouts were higher for trial verdicts than for settlement/arbitration, with a nominal average of $1,140,473 $841,683 versus $788,533 $306,186 awarded to the plaintiff, respectively (p = 0.30). Percentage of cases per US region (center). Lehmann TR, LaRocca HS: Repeat lumbar surgery: A review of patients with failure from previous lumbar surgery treated with spinal canal exploration and lumbar spine fusion. Although pedicle screw fixation opened a new horizon of spinal surgery by providing rigid fixation of the spine, it is a technically demanding procedure with potential complications including medical complications, hardware and technical problems, and long-term changes of junctional motion segments. Using chi square analysis, statistically significant correlation was seen between disc space narrowing and loss of postoperative correction (p < 0.01). $ = US$. 2012;41(2):6973. Personal consequences of malpractice lawsuits on American surgeons. Aigner R, Bichlmaier C, Oberkircher L, Knauf T, Knig A, Lechler P, Ruchholtz S, Frink M. BMC Musculoskelet Disord. This occurred on only one side and the correction achieved by the instrumentation was maintained. pedicle screw misplacement malpractice Spine 13:696706, 1988. Both of these patients complained of thigh pain but refused any additional surgery. Grubb SA, Lipscomb HJ: Results of lumbosacral fusion for degenerative disc disease with and without instrumentation: Two- to five-year follow-up. Incidence and costs of defensive medicine among orthopedic surgeons in the United States: a national survey study. Pullout strength of misplaced pedicle screws in the thoracic and lumbar However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. Neurosurgical practice liability: relative risk by procedure type. A Cotrel-Dubousset spinal system (Medtronic Sofamor Danek, Memphis, TN) was used in all patients and the total number of screws used was 658. The patient suffered permanent nerve damage as a result of the puncture. Despite this problem, the clinical result was excellent. A high-low agreement is a settlement in which a defendant agrees to pay the plaintiff a minimum recovery in exchange for the plaintiff agreeing to accept a maximum amount regardless of the trial's outcome. Li HM, Zhang RJ, Shen CL. Risk factor analysis showed smaller Cobb angles increased likelihood of all screws being AP. The amount awarded was not significantly different across US regions (p = 0.9; Fig. Instead, the defense offered up an alternative explanation for Nyquists foot drop. Guzek RH, Mitchell SL, Krakow AR, Harshavardhana NS, Sarkissian EJ, Flynn JM. In the current series, there were no cases of screw misplacement or vascular or neurologic complications caused by implant application. 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. 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. All the incidental dural tears were repaired immediately and produced no clinical sequelae. Unable to load your collection due to an error, Unable to load your delegates due to an error. Facebook Google Plus Youtube RSS Email. J Neurosurg Spine. Med Econ. Surg Neurol. 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. 30. Conclusion: Pedicle screw replacement in spinal surgery - The MDU 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. Over 40% of patients had screws with either some/major concern. Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort. Among the plaintiff-awarded cases, 13 (61.9%) were decided by jury trial, 7 (33.3%) by settlement, and 1 (4.8%) by arbitration. Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. Please do not include any confidential or sensitive information in a contact form, text message, or voicemail. Methods. Each side was judged separately. 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 . However, the medicolegal impact of misplaced screws on spine surgery has not been directly reported in the literature. Nahed BV, Babu MA, Smith TR, Heary RF. 37. 15. However, only a few complications were related to a poor clinical outcome. Several limitations should be carefully considered when interpreting our results. Screws penetrating the anterior cortex and abutting vascular structures, particularly aortic abutment with left-sided screws, which can lead to erosion and pseudoaneurysms. Clin Orthop 203:7598, 1986. St Louis, CV Mosby 322327, 1987. 2007;106(6):11081114. 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. 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. 8600 Rockville Pike 2012;37(1):6776. 2002;27(22):24252430. Spine (Phila Pa 1976). Malpositioned pedicle screw resulting | Legal Advice - LawGuru 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. 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 Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders, deformities, and trauma. 1 To be effective, the pedicle screw constructs must withstand intraoperative loading and physiological forces due to daily postoperative activities. Retrospective analysis of reasons and revision strategy for failed thoracolumbar fracture surgery by posterior approach: a series of 31 cases. Pedicle Screw Malposition Expert Witness: Malposition Can Lead to 2011;365(7):629636. Statistical analysis: Sankey. 2014;20(2):196203. Pedicle screw accuracy in thoracolumbar fractures- is routine Sarwahi V, Ayan S, Amaral T, Wendolowski S, Gecelter R, Lo Y, Thornhill B. Spine Deform. 2014 Sep;21(3):320-8. doi: 10.3171/2014.5.SPINE13567. The average followup was 35 months (range, 1851 months). Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. An official website of the United States government. 2013;34(6):699705. Fortunately, most of the complications were minor and transient. Accuracy of C2 pedicle screw placement using the anatomic freehand technique. Wolters Kluwer Health Robotic-assisted pedicle screw placement fails to reduce overall 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. Makhni MC, Park PJ, Jimenez J, 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. Linking and Reprinting Policy. 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. Neurosurgeons and orthopedic surgeons were named as the defendant in an equal number of cases, and the decision for the plaintiff versus the defendant was also similar between specialties. In the other patient, L4L5 float arthrodesis was done. 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. Unilateral nonunion was seen in three patients (2.7%), associated with implant failure in one of the patients. Katonis, Pavlos MD*; Christoforakis, Joseph MD*; Aligizakis, Agisilaos C. MD*; Papadopoulos, Charalampos MD*; Sapkas, George MD, DSc**; Hadjipavlou, Alexander MD*. Spine (Phila Pa 1976). 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. When adjusted for inflation, these values increased to $1,330,201 $882,023 versus $970,832 $381,619, respectively (p = 0.32; Fig. Re: malpositioned pedicle screw resulting in additional surgery and disability. 9. Of note, the award amount for one settlement case was undisclosed. Rovit RL, Simon AS, Drew J, et al. 39. 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. In addition, hardware failures were observed in 12 patients (10.7%), junctional problems were seen in five patients (4.5%), problems in the instrumented segments were seen in 39 patients (34.7%), and problems of balance occurred in five patients (4.5%). Nottmeier EW, Seemer W, Young PM. I won't be at the office but I will check my voice mail. Bookshelf Deyo RA, Mirza SK, Martin BI. Results. Lumbar Spine Surgery. Problems in the instrumented segments were considered those occurring from narrowing of the disc space greater than 3 mm, pseudarthrosis, and loss of reduction. 5. Accuracy and workflow of navigated spinal instrumentation with the mobile AIRO CT scanner. 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. 2012;89(10):7071. 12. were excluded from analysis. 25. Spine 18:983991, 1993. Ultimately, no significant differences were seen in inflation-adjusted award information between plaintiff and defendant (Table 3). Screw Malposition: Are There Long-term Repercussions to Malposition of Pedicle Screws? The last two patients had a T12L1 fracture-dislocation and a L4L5 spondylolytic spondylolisthesis at the site of plug dislodgments. Quraishi NA, Hammett TC, Todd DB, et al. Pedicle Screw Insertion in Spondylitis Tuberculosis | ORR 2006;65(4):416421. Clin Orthop 203:717, 1986. The screws were needed to stabilize the spine and fix the fused vertebrae in place. At the trials close, the plaintiffs attorney had asked the jury to return a $5.3 million verdict and had made a prior demand to settle the medical malpractice lawsuit for $1 million. Seven hundred sixty-three screws were inserted in 138 patients. Routine CT scans were taken in all patients. The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. Partner, Paul M. da Costa, Obtains $4.5 Million Verdict - Snyder Sarno Am J Orthop. Brodsky AE: Post-laminectomy and post-fusion stenosis of the lumbar spine. 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. 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). These complications may have resulted from powerful bending movement acting on the screw at its entry point to the bone. The standard imaging technique for pedicle screw insertion is two-dimensional images obtained from C-arm-type X-ray fluoroscopy. 2021 Nov;9(6):1541-1548. doi: 10.1007/s43390-021-00377-5. The most frequent primary injury listed for a lawsuit was nerve root injury, present in 81.0% (n = 17) and 74.5% (n = 35) of plaintiff- and defendant-awarded cases, respectively (p = 0.7). Erwin WD, Dickson JH, Harrington PR: Clinical review of patients with broken Harrington rods. J Neurosurg. Spine 6:615619, 1981. Mississippi Appellate Court Affirms Medical Malpractice Defense Verdict What can spine surgeons do to improve patient care and avoid medical negligence suits? 2020;11:38. South Med J 62:17, 1969. 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. Ann R Coll Surg Engl. Defensive medicine in neurosurgery: the Canadian experience. The average age of the patients was 47 years and the average followup was 35 months. Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. Although the rationale for using pedicle screw fixation is fairly clear, controversy continues regarding the application of pedicle instrumentation for spine arthrodesis, especially on the degenerative lumbar spine. Spine J. One hundred twelve consecutive patients were entered into a retrospective study of instrumented thoracolumbar, lumbar, and lumbosacral spinal arthrodesis at our institution, between September 1994 and January 1999. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. The https:// ensures that you are connecting to the 2022 Jun;8(2):234-241. doi: 10.21037/jss-22-28. This was followed by pseudarthrosis requiring revision surgery, present in 14.3% (n = 3) and 14.9% (n = 7) of plaintiff- and defendant-awarded cases, respectively (p = 0.99). Luque ER: Segmental spinal instrumentation of lumbar spine. Patient-specific 3D-printed surgical guides for pedicle screw insertion Pedicle screws have been used to treat spinal disorders, including those caused by spinal cancer, congenital anomalies, trauma, and chronic pain syndromes. 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. Spine 18:18621866, 1993. Studdert DM, Mello MM, Sage WM, et al. 27,30 Infected pseudarthrosis developed in one patient (0.9%) with an L4S1 arthrodesis, and the instrumentation was removed 18 months later resulting in a flat back syndrome. 2016;124(5):15241530. Yuan HA, Garfin SR, Dickman CA, Mardjetko SM: A historical cohort study of pedicle screw fixation in thoracic, lumbar and sacral spinal fusions. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Din RS, Yan SC, Cote DJ, et al. Disclaimer. Whitecloud III TS, Butler JC, Cohen JL, Candelora PD: Complications with the variable spinal plating system. The .gov means its official. shooting in valdosta leaves one dead Jury Verdict for Doctor for Screw Allegedly Misplaced During Lumbar Many technological advances have been made over the past several decades in an effort to improve the accuracy of screw placement in spine surgery.3436 For example, 3D fluoroscopybased image guidance has been shown to decrease the pedicle breach rate in several studies compared to the rate with 2D fluoroscopic guidance or the freehand technique, particularly in deformity and revision surgeries.21,34,36,37 CT guidance or intraoperative confirmation has also been shown to further improve the accuracy of pedicle screw placement,3638 with reported accuracy rates of 89%100% reported in the literature, depending on the authors breach criteria.35 However, it is important to note that the use of this technology is often accompanied by a lower threshold for intraoperative screw revision, sometimes leading to higher rates of replaced screws.33 Arguably, these improved trajectories may avoid iatrogenic neurological deficits due to prolonged nerve root compression or even improve the stability of the construct;34,37 however, prospective studies of long-term outcomes and rates of revision surgery remain sparse in the literature.
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