2. 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JAMA. J Neurosurg Spine. Moffatt-Bruce SD, Ferdinand FD, Fann JI. Conclusion: J Spinal Disord Tech. Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison. The contact form sends information by non-encrypted email, which is not secure. The link was not copied. Plaintiff-awarded cases by US region (left). Please do not include any confidential or sensitive information in a contact form, text message, or voicemail. 2019;19(7):12211231. The rate of reoperation for screw misplacement per screw was 0.17%. This study quantifies the rate of screw misplacement on a per-patient basis to highlight its effect on potential morbidity. Malpractice issues in neurological surgery. 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. Eur Spine J. Spine 6:615619, 1981. Fager CA. Pedicle screw placement: Robotic assistance for greater precision Under the high-low agreement, Drs. The purpose of current study was to analyze the complications and problems during and after pedicle screw fixation for various spinal disorders and trauma. Arthrodesis was questionable in eight asymptomatic patients (7.1%). Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. Careers. Pitfall: Unstable injuries. Your current browser may not support copying via this button. Zdeblick TA: A prospective randomized study of lumbar fusion: Preliminary results. 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. In patients with degenerative conditions, all of the affected segments were included in the instrumentation and each vertebra was fixed with two pedicle screws. Preparation. Surg Neurol. 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. J Bone Joint Surg 62A:13021307, 1980. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. Melissa Nyquist required a lumbar back fusion for a herniated disc at the L4-5 level. Descriptive analysis of state and federal spine surgery malpractice litigation in the United States. There were nine instrumentation failures at the thoracolumbar area (seven patients), lumbar area (one patient), and lumbosacral area (one patient). The initial search using the terms above returned 3654 cases. 5. Spine 18:11601172, 1993. 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. Misplacement rates have been reported to be from 5 to 41% in the lumbar spine and from 3 to 55% in the . Spinal fusion procedures are increasingly performed each year, with Deyo et al. Lumbosacral pedicle screw placement using a fluoroscopic pedicle axis 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. Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. Reprint requests to Pavlos Katonis, MD, 99 Minoos & Thenon Street, 71305, Heraklion, Crete, Greece. Schatlo B, Molliqaj G, Cuvinciuc V, et al. Mississippi Appellate Court Affirms Medical Malpractice Defense Verdict Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. Wolters Kluwer Health A retrospective review of charts, x-rays (XRs) and computed tomography (CT) scans was performed. Per-patient analysis reveals more concerning numbers toward screw misplacement. PMC 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). 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. Presse Med 78:14471448, 1970. National Library of Medicine 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). shooting in valdosta leaves one dead 34. J Bone Joint Surg 54A:11951204, 1972. 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. 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. Spine (Phila Pa 1976). 14. 2011;365(7):629636. 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. Neurosurgery. Neurological Outcome and Management of Pedicle Screws Misplaced Totally 39. Am J Otolaryngol. Use of the Airo mobile intraoperative CT system versus the O-arm for transpedicular screw fixation in the thoracic and lumbar spine: a retrospective cohort study of 263 patients. These numbers are in line with the current literature. PLoS One. NCI CPTC Antibody Characterization Program. 2,24,28,36. A p < 0.05 was considered statistically significant. Over 40% of patients had screws with either some/major concern. 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. Edmunds I, Cummine J, Fearnside M: Prevention of dislodgement of Cotrel-Dubousset rods from tulip screws. Spine (Phila Pa 1976). [] The accuracy for free-hand screw placement technique varies from 69% to 94%. 32. 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. Critically revising the article: all authors. Complications and Problems Related to Pedicle Screw Fixation - LWW Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. On average, physicians spend nearly 11 percent of their 40-year careers with an open, unresolved malpractice claim. * 2014 Sep;21(3):320-8. doi: 10.3171/2014.5.SPINE13567. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Methods. 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. George Sapkas, MD, DSc; and Panayiotis J. Papagelopoulis, MD, DScGuest Editors. 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. J Neurosurg Spine. 29. All these problems were observed only just above the upper instrumentation level and all were observed in patients older than 55 years. The rate of medical complications was 8%. Pedicle screw | definition of pedicle screw by Medical dictionary The patient had subsequent coronal imbalance and degeneration of the upper disc. Moreover, local court rulings are not included in the Westlaw Edge database; however, this is unlikely to present meaningful bias given that malpractice claims are generally filed in state courts. Personal consequences of malpractice lawsuits on American surgeons. 2014;174(11):18671868. Long spine fixation was necessary for patients with tuberculous spondylitis and metastatic disease. St Louis, CV Mosby 322327, 1987. 1). Neurologic injury. Ultimately, no significant differences were seen in inflation-adjusted award information between plaintiff and defendant (Table 3). Intraoperative and postoperative complications were recorded by the authors and the results were evaluated by an independent observer. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? Furthermore, 25 patients (22.3%) reported persistent pain in the iliac crest (donor graft site) for several months, for which they were treated with repeated lidocaine injections and analgesics. True accuracy of percutaneous pedicle screw placement in thoracic and For more information, please refer to our Privacy Policy. 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. I won't be at the office but I will check my voice mail. In five patients with thoracolumbar injuries, who were the first treated in the current series, and in four patients with fractures in the lower lumbar spine, two-segment fixation was used. Risk Factors for the Drift Phenomenon in Oarm NavigationAssisted Katonis PG, Kontakis GM, Loupasis GA, et al: Treatment of unstable thoracolumbar and lumbar spine injuries using Cotrel-Dubousset instrumentation. Sarwahi V, Ayan S, Amaral T, Wendolowski S, Gecelter R, Lo Y, Thornhill B. Spine Deform. This study revealed an overall accuracy rate of 95.2% of mainly percutaneously inserted pedicle screws according to the classification of Zdichavsky et al. 2009;10(1):3339. Neurosurgery. 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. Zucherman J, Hsu K, Picetti III G, et al: Clinical efficacy of spinal instrumentation in lumbar degenerative disc disease. Spine 13:696706, 1988. Department of Neurosurgery, Spine Division, Duke University Medical Center, Durham, North Carolina; and, Malpractice liability and defensive medicine: a national survey of neurosurgeons, Defensive medicine among high-risk specialist physicians in a volatile malpractice environment, Defensive medicine: a culprit in spiking healthcare costs, Incidence and costs of defensive medicine among orthopedic surgeons in the United States: a national survey study, Defensive medicine in U.S. spine neurosurgery, Personal consequences of malpractice lawsuits on American surgeons. The screws were needed to stabilize the spine and fix the fused vertebrae in place. 19. 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. 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. 2021 Nov;9(6):1541-1548. doi: 10.1007/s43390-021-00377-5. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiffs spine. 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. Judgment information associated with a defendant (surgeon) versus plaintiff (patient) ruling, trial versus settlement versus arbitration decision, award amount, and time to decision or case closure from index surgery was also recorded. Brodsky AE: Post-laminectomy and post-fusion stenosis of the lumbar spine. Epub 2021 Aug 28. Thu, May 27th, 2021. Studdert DM, Mello MM, Sage WM, et al. Additional survey data have shown that 50% of physicians exhibit at least a temporary loss of self-esteem after a malpractice claim, and at least 25% experience depression.22 As stated above, the average neurosurgeon spends 27.2% of his or her entire career in an open malpractice claim,10 and each case can take an average of 5.1, 5.0, and 3.4 years for defendant verdicts, plaintiff rulings, and settlements, respectively.7,15 Likewise, neurosurgeons have a higher risk than practitioners in other specialties of being named in multiple malpractice suits given the particularly high-risk nature of the specialty.10 Even when found in favor of the defendant (surgeon), each case ultimately takes a substantial emotional and financial toll on the physician(s) involved. Hsu K, Zucherman JF, White AH: Internal Fixation With Pedicle Screws. 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. 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 8,24,25,32. 22. Despite these failures, solid spinal arthrodesis was obtained in all patients. In White AH, Rothman RH, Ray CD (eds). Thankfully, most screws are just misplaced by a millimeter or two out the front or are slightly off medially, so they are not doing real damage. 27. All the operations were done by one surgeon (PK). $ = US$. Screw Malposition: Are There Long-term Repercussions to Malposition of Pedicle Screws? 2005;293(21):26092617. 8600 Rockville Pike 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. Open lumbar pedicle screw technique - Operative Neurosurgery FOIA Unauthorized use of these marks is strictly prohibited. doi: 10.1097/BRS.0b013e31822a2e0a. Int Orthop 20:3542, 1996. 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. Bethesda, MD 20894, Web Policies J Spine Surg. PURPOSE This study aimed to compare rates of perioperative complications between robotic-assisted and conventional . These risks can be minimized by the judicious use of instrumentation by experienced surgeons for specific indications as supported by the literature. Erwin WD, Dickson JH, Harrington PR: Clinical review of patients with broken Harrington rods. single homes for sale in lehigh valley, pa pedicle screws sagittal alignment spinal fusion surgical guides Spinal fusion is used to treat a range of conditions associated with spinal column such as intervertebral disc degeneration and scoliosis [ 1 ]. 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 . your express consent. Clin Orthop 227:1023, 1988. Please enable it to take advantage of the complete set of features! Spine 18:18621866, 1993. 33. An official website of the United States government. Luque ER: Segmental spinal instrumentation of lumbar spine. Two patients had an acute infection develop for which they required operative intervention with irrigation and debridement. Krag MH, Beynnon BD, Pope MH, et al: An internal fixator for posterior application to short segment of the thoracic, lumbar, or lumbosacral spine. Malpositioned pedicle screw resulting | Legal Advice - LawGuru 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. Once the spine is exposed, the appropriate levels of fixation are confirmed with the image intensifier. Analysis and interpretation of data: Sankey, TT Than. 2012 Feb 1;37(3):E188-94. The plaintiff received $2.4 million for pain and suffering and loss of enjoyment of life, $2 million for lost income and approximately $123,000 for medical expenses. 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. Spine 18:983991, 1993. Orthop Trans 11:99, 1987. 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. 6. In the current series, there were no cases of screw misplacement or vascular or neurologic complications caused by implant application. doi: 10.1097/BPO.0000000000001828. 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. Twenty-one patients (18.8%) had thoracolumbar injuries, and loss of immediate postoperative deformity correction ranged from 1.4 to 4.5. Thus, we are unable to comment on whether all misplaced screws, particularly when asymptomatic, should be revised in an effort to prevent litigation. Spine 14:472476, 1989. All the incidental dural tears were repaired immediately and produced no clinical sequelae. J Am Coll Surg. Medical malpractice litigation has made a significant impact on spine surgery, with many spine surgeons avoiding complex cases or practicing other defensive medicine tactics in an effort to avoid being sued.5 Moreover, the majority of neurosurgeons spend more than 10% of their annual revenue on malpractice insurance,1,14 and the excessive financial risk of litigation is even leading some insurers to no longer offer coverage to spine surgeons.19 A 2011 study in the New England Journal of Medicine found that 19.1% of neurosurgeons are named as a defendant in a malpractice suit each year (highest of any specialty).12 Moreover, 88% of physicians in high-risk specialties, like neurosurgery, are involved in a lawsuit by age 45, increasing to a concerning 99% by 65 years of age.12 Such litigation places a substantial financial, temporal, and emotional burden on physicians in high-risk specialties, with studies showing that up to 72% of neurosurgeons1 admitted that their fear of litigation significantly influenced their practice,25 with many avoiding high-risk patients altogether.1 Similarly, Nahed et al. At the lumbosacral area, breakage of a divergent screw of a Chopin block occurred on only one side with no loss of correction. 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. 2. Hecht N, Kamphuis M, Czabanka M, et al. Mukherjee S, Pringle C, Crocker M. A nine-year review of medicolegal claims in neurosurgery. Data is temporarily unavailable. Jury awards $4.5M over misplaced pedicle screw during spine surgery: 5 Moreover, several cases stated that the surgeon used only the anteroposterior or the lateral view, but not both, and the plaintiffs counsel used this information in support of their claim. Mayo Clinic uses the latest robot-assisted technology when indicated to enhance surgical precision in these procedures. 2017;27(4):470475. Screw misplacement. Delayed open treatment of aortic penetration by a thoracic pedicle 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. Edwards CC: Spinal screw fixation of the lumbar and sacral spine: Early results treating the first 50 cases. Linking and Reprinting Policy. Amount awarded to plaintiffs by US region, adjusted for inflation as of April 2020. Larson AN, Santos ER, Polly DW Jr, Ledonio CG, Sembrano JN, Mielke CH, Guidera KJ. PDF Intraoperative biomechanics of lumbar pedicle screw loosening following Clin Orthop 203:126134, 1986. Pedicle Screw Insertion in Spondylitis Tuberculosis | ORR