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). Spine 15:908912, 1990. 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. Eur Spine J. Wiltse LL, Spencer CW: New uses and refinements of the paraspinal approach to the lumbar spine. Preparation. Elsamadicy AA, Sergesketter AR, Frakes MD, Lad SP. 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. Quinnell RC, Stockdale HR: Some experimental observations of the influence of a single lumbar floating fusion on the remaining lumbar spine. Pedicle screw accuracy in thoracolumbar fractures- is routine postoperative CT scan necessary? 0 attorneys agreed. Conception and design: Sankey, KD Than. Guzek RH, Mitchell SL, Krakow AR, Harshavardhana NS, Sarkissian EJ, Flynn JM. 2014;20(6):636643. Ultimately, no significant differences in case demographics were found between plaintiff and defendant judgments (Table 1). Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. (A) Anteroposterior and (B) lateral radiographs taken 2 years after surgery show unilateral pseudarthrosis in a 55-year-old man with spinal stenosis. The rate of reoperation for screw misplacement per screw was 0.17%. With increasing pedicle screw usage, the number of patients with misplaced screws will likely increase proportionally. 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. West III JL, Bradford DS, Ogilvie JW: Complications of the variable screw pedicle screw fixation. 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. These risks can be minimized by the judicious use of instrumentation by experienced surgeons for specific indications as supported by the literature. 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. Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison. 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. The jury found the defendants liable and allocated 75 percent of the fault to Dr. Friedlander and 25 percent to Dr. Bradley. Pedicle screw insertion techniques: an update and review of the Ahmadi SA, Sadat H, Scheufler KM, et al. All the incidental dural tears were repaired immediately and produced no clinical sequelae. Thus, in the current study we aimed to describe this impact in the US, as well as to suggest a potential method for mitigating the problem. (A) Anteroposterior and (B) lateral radiographs taken 1 year after surgery show upper screw breakage in the application of a short Cotrel-Dubousset construct in a T12 burst fracture. 25. There were two complete degenerations of the upper disc, one central canal stenosis, and two asymptomatic disc space narrowings and retrolistheses. HHS Vulnerability Disclosure, Help 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. Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. 4. 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. 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. Acquisition of data: Sankey. Misplaced pedicle and lateral mass screws result in a considerable risk of malpractice litigation against spine surgeons. 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. INCLUDE WHEN CITING DOI: 10.3171/2020.8.FOCUS20600. Clin Orthop 203:717, 1986. Spine 16:576579, 1991. 13. In order to prove medical malpractice occurred, the plaintiffs attorney needs to show not only the plaintiff experienced a poor medical outcome, but that it was directly caused by medical negligence. Axial lumbar CT scans demonstrating both laterally (right) and medially (left) misplaced pedicle screws, resulting in pedicle and transverse process fractures (A) and canal compromise (A and B). 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 Results: 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. 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. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Federal government websites often end in .gov or .mil. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 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. 2016;124(5):15241530. 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. 3. It is an effective procedure in that it provides an almost immediate stabilization of the spine [ 2-5 ]. 12. 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). doi: 10.1097/BPO.0000000000001828. Spine 6:263267, 1981. Neurological Outcome and Management of Pedicle Screws Misplaced Totally A total of 47 (69.1%) cases resulted in a decision for the defendant and 21 (30.9%) for the plaintiff. J Neurosurg Spine. 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. 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. 2018;27(9):23392347. Bydon M, Xu R, Amin AG, Macki M, Kaloostian P, Sciubba DM, Wolinsky JP, Bydon A, Gokaslan ZL, Witham TF. Defensive medicine: a culprit in spiking healthcare costs. 70% of Pedicle Screws are misplaced - orthostreams.com 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. 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. Forty-seven general complications were seen in 41 patients (36.5%). $ = US$; MW = Midwest; NE = Northeast; SE = Southeast; SW = Southwest; W = West. However, the impact of robotic-assisted spinal fusion on patient outcomes is less clear. Edmunds I, Cummine J, Fearnside M: Prevention of dislodgement of Cotrel-Dubousset rods from tulip screws. J Bone Joint Surg 54A:11951204, 1972. 2021 Nov 26;22(1):986. doi: 10.1186/s12891-021-04860-y. 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. Jury Verdict for Doctor for Screw Allegedly Misplaced During Lumbar 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. 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. Several limitations should be carefully considered when interpreting our results. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement Excessive hemorrhage occurred in two patients (1.8%) with coagulation disorders. CT-navigation versus fluoroscopy-guided placement of pedicle screws at This patient recovered completely in 6 weeks. Jena AB, Seabury S, Lakdawalla D, Chandra A. The plaintiff underwent revision surgery in May 2013. Better strategies need to be devised for evaluation of screw placement, including establishment of a national database of deformity surgery, use of intra-operative image guidance, and reevaluation of postoperative low-dose CT imaging. 2017 Mar;5(2):109-116. doi: 10.1016/j.jspd.2016.10.007. Bydon M, Xu R, Amin AG, et al. Nahed BV, Babu MA, Smith TR, Heary RF. Disclaimer. A Cotrel-Dubousset spinal system (Medtronic Sofamor Danek, Memphis, TN) was used in all patients and the total number of screws used was 658. 2014;75(6):609613. 4). Screw Malposition: Are There Long-term Repercussions to Malposition of Pedicle Screws? Pedicle instrumentation in the thoracolumbar and lumbar spine is a technically challenging procedure. The largest inflation-adjusted payout awarded to the plaintiff ($3,372,185) for nerve root injury occurred in a 36-year-old male who had undergone an L4S1 posterior spinal fusion, which resulted in permanent and direct injury to right L5 and S1 nerve roots, with foot drop and radiculopathy. 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). Steinmann JC, Herkowitz HN: Pseudarthrosis of the spine. 2020;11:38. 2014;20(2):196203. Cookie Policy. EOS System Courtesy of EOS imaging. J Neurosurg Spine. Studdert DM, Mello MM, Sage WM, et al. 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. sharing sensitive information, make sure youre on a federal Spine 8:970981, 1996. Pedicle screw placement is a common procedure. 23. Stauffer RN, Coventry MB: Posterolateral lumbar-spine fusion: Analysis of the Mayo clinic series. The patient had subsequent coronal imbalance and degeneration of the upper disc. Likewise, cases are uploaded on a voluntary basis by state and federal judges and courts, which may lead to selection bias. Spine 19(20 Suppl):2279S2296, 1994. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement. JAMA Intern Med. 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. J Neurosurg Spine. J Bone Joint Surg 62A:13021307, 1980. 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. Hsu K, Zucherman JF, White AH: Internal Fixation With Pedicle Screws. Study design: 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. 11. Plaintiff's expert was prepared to testify at trial that these complaints are characteristic of a malpositioned screw impinging upon a neural structure.

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