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Hsu K, Zucherman JF, White AH: Internal Fixation With Pedicle Screws. N Engl J Med. 2018;43(14):984990. 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. Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. Breakage of a divergent screw of a Chopin block at the lumbosacral area was seen 3 months after surgery. Background The objective of this cadaveric study was to analyze the effects of iatrogenic pedicle perforations from screw misplacement on the mean pullout strength of lower thoracic and lumbar pedicle screws. Analysis and interpretation of data: Sankey, TT Than. These numbers are in line with the current literature. 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. 1. 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. Unfortunately, the plaintiffs attorney was unable to offer an alternative theory of surgical negligence that would refute the defendants explanation. Administrative/technical/material support: Mehta, Wang, KD Than. The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. 2018;41(5):e615e620. However, the highest offer had been a combined $300,000 from the two defendants. 2018;28(2):186193. 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. Screw Malposition: Are There Long-term Repercussions to Malposition of Pedicle Screws? 2012;21(suppl 2):S196S199. This demonstrates technical ability but does not represent the impact of screw misplacement on individual patients. 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 cost of defensive medicine on 3 hospital medicine services, Defensive medicine in neurosurgery: the Canadian experience, Review of neurosurgery medical professional liability claims in the United States, A nine-year review of medicolegal claims in neurosurgery, Malpractice risk according to physician specialty, Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003, Descriptive analysis of state and federal spine surgery malpractice litigation in the United States, Malpractice litigation following spine surgery, Medical malpractice in orthopedic surgery: a Westlaw-based demographic analysis, Malpractice claims in spine surgery in Germany: a 5-year analysis, On average, physicians spend nearly 11 percent of their 40-year careers with an open, unresolved malpractice claim, Malpractice litigation and the spine: the NHS perspective on 235 successful claims in England, Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort, It is easier to confuse a jury than convince a judge: the crisis in medical malpractice, Determining legal responsibility in otolaryngology: a review of 44 trials since 2008, Legal liability in iatrogenic orbital injury, Spine neurosurgeons facing the judicialization of their profession: disenchantment and alteration of daily practicea qualitative study, Malpractice issues in neurological surgery. In 2 patients, misplacement of pedicle screws was recognized intraoperatively and all implants were removed. pedicle screw misplacement malpractice. and transmitted securely. 26. The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. The intent is to provide relief from pain and nerve damage. However, only a few complications were related to a poor clinical outcome. This retrospective study analyzes the complications and the problems developed during and after pedicle screw fixation in patients with spinal disorders and trauma. 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. 8,24,25,32. Harris RI, Wiley JJ: Acquired spondylolysis as a sequel to spine fusion. (A) Anteroposterior and (B) lateral radiographs taken 2 years after surgery show unilateral pseudarthrosis in a 55-year-old man with spinal stenosis. The accuracy rate of pedicle screw (PS) placement varies from 85% to 95% in the literature. 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. Presse Med 78:14471448, 1970. 2014;174(11):18671868. Spine fixation included one segment in 27 patients, two segments in 38 patients, three segments in 42 patients, and more than three segments in five patients. Thu, May 27th, 2021. 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. 3,4,9,29,34 In addition, developments in surgical technique and implant design have decreased operative risk and implant-related complications. Overall reported screw misplacement is low, but it does not reflect the potential impact on patient morbidity. From the *Department of Orthopaedic Surgery, University of Crete Medical School, Heraklion, Greece; and the **First Department of Orthopaedics, University of Athens Medical School, Athens, Greece. 2014 Sep;21(3):320-8. doi: 10.3171/2014.5.SPINE13567. + 48 696 042 504. 10. The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. 2016;25(3):716723. 2012;89(10):7071. 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 Of the 112 patients, 57 patients had a lumbar degenerative disorder, (lumbar degenerative spinal canal stenosis in 23 patients, degenerative or spondylolytic spondylolisthesis in 12 patients, postlaminectomy instability or stenosis in 20 patients, and recurrent disc prolapse in two patients), 42 patients had spinal cord injury, eight patients had infection, and five patients had a spinal tumor (Table 1). Segal J. For more information, please refer to our Privacy Policy. Three slender patients complained of soft tissue irritation and a bothersome prominence because of the screws bulky profile. However, despite the apparent widespread use of pedicle system fixation, few studies of problems and particularly complications have been published. L3S1 spine arthrodesis was done in the first patient but the correction of scoliosis was not sufficient and coronal imbalance persisted after surgery, which accelerated the degeneration of the level just above the arthrodesis. Excessive hemorrhage occurred in two patients (1.8%) with coagulation disorders. J Neurosurg Spine. Spine 6:615619, 1981. Disclosures Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. JAMA. In six patients (5.3%) with degenerative spine disease, the disc material had been removed. 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? sharing sensitive information, make sure youre on a federal This site needs JavaScript to work properly. Characteristics of medicolegal cases related to misplaced screws in spine surgery. Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison. Larson AN, Santos ER, Polly DW Jr, Ledonio CG, Sembrano JN, Mielke CH, Guidera KJ. $2 Million Spinal Surgery Case Against Neurosurgeon and Hospital Cookie Policy. 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. 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. 2013;32(1):111119. In the current series, there were no cases of screw misplacement or vascular or neurologic complications caused by implant application. Three-dimensional printing versus freehand surgical techniques in the surgical management of adolescent idiopathic spinal deformity. The link was not copied. 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. 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. Epstein NE. None of these complications resulted in additional surgery or in a significant increase of morbidity. 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. Defensive medicine in U.S. spine neurosurgery. 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. Spine 18:11601172, 1993. Retrospective Computed Tomography Scan Analysis of Percutaneously Spine 18:18621866, 1993. PDF Intraoperative biomechanics of lumbar pedicle screw loosening following These complications may have resulted from powerful bending movement acting on the screw at its entry point to the bone. leg pain. Defensive medicine: a culprit in spiking healthcare costs. Over 40% of patients had screws with either some/major concern. 16,24,28 Simultaneously, the evolution of the surgical techniques has led to increased procedural safety. Call me tomorrow. The radiology results showed that the surgical screw placed at the right L4-5 area had breached the medial wall and was actually extending into the spinal canal. Pitfall: Unstable injuries. A p < 0.05 was considered statistically significant. Problems in the instrumented segments were considered those occurring from narrowing of the disc space greater than 3 mm, pseudarthrosis, and loss of reduction. The majority of plaintiffs were male (n = 44, 64.7%), and the median age among all cases was 46 years (range 3757 years). Pedicle screw accuracy in thoracolumbar fractures- is routine postoperative CT scan necessary? Copyright © 2023 Becker's Healthcare. pedicle screw misplacement malpractice Pediatric pedicle screw placement using intraoperative computed tomography and 3-dimensional image-guided navigation. 18. Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. And while the jury debated for about two hours, at the end of its deliberation it sided with the defendants and entered a not guilty verdict. Schatlo B, Molliqaj G, Cuvinciuc V, et al. Pedicle screw placement is a common procedure. 2. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? 4. your express consent. Statistical analysis: Sankey. Illinois Jury Finds in Favor of Doctor in Gallbladder Surgery that Led to Fatal Bowel Perforation Nickl v. Barry S. Rosen, M.D. 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). However, the misplacement of pedicle screws can lead to disastrous complications. 2. Seven hundred sixty-three screws were inserted in 138 patients. All Rights Reserved. Pedicle Screw Malposition Expert Witness: Malposition Can Lead to Drs. Before Several limitations should be carefully considered when interpreting our results. Long spine fixation was necessary for patients with tuberculous spondylitis and metastatic disease. 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. Pedicle screw placement accuracy impact and comparison between grading 4. Potential complications may include increased pain, infection, or mechanical . Am J Orthop. Acta Neurochir (Wien). 32. A total of 247 screws (9.07%) were BMP, 52 (1.91%) were IMP, and 29 (1.06%) were considered SAR. 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. Clin Orthop 203:4553, 1986. 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. Rothberg MB, Class J, Bishop TF, et al. In the current series, including general complications, only 48 patients (43%) had no notable complication and the remaining 64 patients (57%) had one or more complications. Likewise, cases are uploaded on a voluntary basis by state and federal judges and courts, which may lead to selection bias. Schlegel JD, Smith JA, Schleusener RN: Lumbar motion segment pathology adjacent to thoracolumbar, lumbar, and lumbosacral fusions. It is indicated that screws medially misplaced at a distance greater than 2-mm, especially 4 mm, may be a cause of negative effects on the neural structure and should be removed during the early phase of the postoperative period, even among patients without postoperative neurological abnormalities. All the incidental dural tears were repaired immediately and produced no clinical sequelae. It has a great developing technique that is used for fixation and fusion in spine surgery. 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. Spine 16(8 Suppl):S455458, 1991. Please do not include any confidential or sensitive information in a contact form, text message, or voicemail. The pedicle screws judged as misplacement. a Medial minor perforation I won't be at the office but I will check my voice mail. 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. Seabury SA, Chandra A, Lakdawalla DN, Jena AB. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. Balch CM, Oreskovich MR, Dyrbye LN, et al. Dalenberg DD, Asher MA, Robinson RG, Jayaraman G: The effect of a stiff spinal implant and its loosening on bone mineral content in canines. 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. 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). Pullout strength of misplaced pedicle screws in the thoracic and lumbar It should be used by experienced and qualified surgeons who are aware of the pitfalls associated with its use. Zdeblick TA: A prospective randomized study of lumbar fusion: Preliminary results. 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. Ultimately, no significant differences in case demographics were found between plaintiff and defendant judgments (Table 1). Conception and design: Sankey, KD Than. Study supervision: Goodwin, Karikari, Shaffrey, Abd-El-Barr, KD Than. 0 attorneys agreed. 23. Screw misplacement. Nayar G, Blizzard DJ, Wang TY, et al. Placement of the pedicle screws in the thoracolumbar and lumbar spine is a technically demanding procedure. Of note, the award amount for one settlement case was undisclosed. 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. Malpractice issues in neurological surgery. Finally, considering the problems of balance, it seems that failure to properly evaluate any preexisting scoliosis was a main cause of this important complication. J Bone Joint Surg 54A:11951204, 1972. Crawford MJ, Esses SI: Indications for pedicle fixation: Results of NASS/SRS faculty questionnaire: North American Spine Society and Scoliosis Research Society. 30. A total of 2396 screws were placed accurately (87.96%). All case demographics are summarized in Table 1. Objective: 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. Clin Orthop 115:130139, 1976. South Med J 62:17, 1969. Epub 2014 Apr 4. Spine 8:970981, 1996. 33. 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%. This occurred on only one side and the correction achieved by the instrumentation was maintained. Insuring spinal neurosurgery. One of the patients had a late wound infection develop that was treated by radical debridement and removal of instrumentation. Reoperation for Misplaced Pedicle Screws: A Multicenter Retrospec Forty-seven general complications were seen in 41 patients (36.5%). Spinal fusion in the United States: analysis of trends from 1998 to 2008. 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. and 17.1% of the patients included had at least one screw misplaced. 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. Zucherman J, Hsu K, Picetti III G, et al: Clinical efficacy of spinal instrumentation in lumbar degenerative disc disease. Patient-specific 3D-printed surgical guides for pedicle screw insertion Results: A total of 2724 screws were placed in 127 patients. 2018;18(2):209215. Spine Deform. 2020;45(2):E111E119. The initial search using the terms above returned 3654 cases. At the lumbosacral area, breakage of a divergent screw of a Chopin block occurred on only one side with no loss of correction. 2014;75(6):609613. Federal government websites often end in .gov or .mil. 11. Melissa Nyquist required a lumbar back fusion for a herniated disc at the L4-5 level. 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. 6 (%), Pseudarthrosis requiring revision surgery. Steinmann JC, Herkowitz HN: Pseudarthrosis of the spine. Neurosurgery. The highly litigious environment within healthcare has resulted in a majority of physicians practicing defensive medicine,15 often leading to burnout6,7 and an exorbitant ethical and financial burden on medical and surgical care.7,8 In 2008, medical liability accounted for $55.6 billion, representing 2.4% of the United States (US) healthcare expenditures that year,5,7,9,10 and the pervasive practice of defensive medicine may cost up to $210 billion annually in the US.5 A similar trend has been observed in Europe.11, Neurosurgery is the specialty most frequently affected by lawsuits and the fear of litigation, both in the US and abroad,12 with spine surgery at the forefront.11,1317 As a result, spine surgeons are nearly three times more likely than nonspine surgeons to practice defensive medicine, defined as the avoidance of high-risk procedures and the provision of unnecessary services and assessments beyond what is clinically necessary in an effort to avoid litagation.5 The average time to judgment in a case is approximately 5.1, 5.0, and 3.4 years for defendant verdicts, plaintiff rulings, and settlements, respectively.7,15 As a result, physicians spend an average of 11% of their careers dealing with one or more open malpractice claims.18 Neurosurgeons are especially impacted, spending an average of 27.2% of their careers in an open lawsuit.10.