Cases involving wrong-level or -side surgery, implant malfunction, or other misplaced spinal instrumentation (e.g., interbody cases, rods, surgical instruments, etc.) Would you like email updates of new search results? Saillant G: Etude anatomique des pedicules vertebraux: Application chirurgicale. doi: 10.1097/BPO.0000000000001828. (%), Pseudarthrosis requiring revision surgery. 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. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). Spinal fusion procedures are increasingly performed each year, with Deyo et al. official website and that any information you provide is encrypted It should be used by experienced and qualified surgeons who are familiar with the pitfalls associated with its use. Spine 18:23252326, 1993. Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. All these problems were observed only just above the upper instrumentation level and all were observed in patients older than 55 years. 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. However, the medicolegal impact of misplaced screws on spine surgery has not been directly reported in the literature. There were no observed cases of screw misplacement outside the pedicle on routine AP and lateral radiographs. Spine 16(8 Suppl):S422427, 1991. On average, physicians spend nearly 11 percent of their 40-year careers with an open, unresolved malpractice claim. These complications may have resulted from powerful bending movement acting on the screw at its entry point to the bone. Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. You may be trying to access this site from a secured browser on the server. Debate Over Extent of Eye Damage Following Implant Lens Surgery Leads to $1 Million Verdict in Zaleski v Elmhurst Eye Surgery Center. laterally placed screws and the azygous vein on the right (T5-T11). Start; O firmie; Usugi; Serwis; Realizacje i porady; Kontakt 0 attorneys agreed. The total number of reoperations for MPS and patient clinical data were obtained from medical records at each hospital. The average followup was 35 months (range, 1851 months). Cerebrospinal fluid fistulas. 37. Nevertheless, research has shown that screws are misplaced in approximately 14%55% of cases using the standard techniques (freehand and 2D fluoroscopic guidance) employed by most spine surgeons,21,33 resulting in injury in approximately 1%8% of cases.21 In addition to the avoidable procedural risk to the patient, each misplaced screw carries the threat of future litigation, as reported above. It is an effective procedure in that it provides an almost immediate stabilization of the spine [ 2-5 ]. Clin Orthop 203:717, 1986. 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). Complete degeneration of the upper disc developed in two patients who had spinal stenosis and degenerative scoliosis. However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. 32. Over 40% of patients had screws with either some/major concern. Surg Neurol. The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. 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. . A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? The last two patients had a T12L1 fracture-dislocation and a L4L5 spondylolytic spondylolisthesis at the site of plug dislodgments. The average age of the patients was 47 years and the average followup was 35 months. 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. Screw misplacement. However, despite the apparent widespread use of pedicle system fixation, few studies of problems and particularly complications have been published. 36. Yuan HA, Garfin SR, Dickman CA, Mardjetko SM: A historical cohort study of pedicle screw fixation in thoracic, lumbar and sacral spinal fusions. All Rights Reserved. Koktekir E, Ceylan D, Tatarli N, Karabagli H, Recber F, Akdemir G. Spine J. 2,24,28,36. Spine J. Defensive medicine in U.S. spine neurosurgery. Patient safety: disclosure of medical errors and risk mitigation. The cost of defensive medicine on 3 hospital medicine services. $ = US$; MW = Midwest; NE = Northeast; SE = Southeast; SW = Southwest; W = West. 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. Results: A total of 2724 screws were placed in 127 patients. 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. Both issues represent the most frequent and highest payouts in spine malpractice claims.10,14,22 While several studies have explored many of the factors related to malpractice claims in spine surgery, the medicolegal impact of misplaced pedicle and/or lateral mass screws has not been directly reported in the literature. Dr. Shaffrey has received grants from the NIH and Department of Defense. Sarwahi V, Ayan S, Amaral T, Wendolowski S, Gecelter R, Lo Y, Thornhill B. Spine Deform. reported that 69.3% of neurosurgeons who responded to their survey saw every patient as a potential lawsuit.1. 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. J Neurosurg Spine. 1,12,19,22 The largest series of adjacent segment breakdown was reported by Schlegel et al. Eur Spine J. Conclusion: The contact form sends information by non-encrypted email, which is not secure. Eur Spine J. 2022 Jun;8(2):234-241. doi: 10.21037/jss-22-28. 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. 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. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. What can spine surgeons do to improve patient care and avoid medical negligence suits? Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders, deformities, and trauma. Spine 15:1114, 1990. Neurologic injury. It has a great developing technique that is used for fixation and fusion in spine surgery. In unstable injuries, the segments above and below the level of injury may have a different orientation of the pedicle trajectory due to . Harris RI, Wiley JJ: Acquired spondylolysis as a sequel to spine fusion. 28. 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. Taylor CL. 2014 Sep;21(3):320-8. doi: 10.3171/2014.5.SPINE13567. 1 Although this technique has advantages over open instrumentation, it also presents new challenges and specific complications. 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%). to maintaining your privacy and will not share your personal information without 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. Nayar G, Blizzard DJ, Wang TY, et al. Orthopedics. First, this is a retrospective analysis of cases obtained from the web-based Westlaw Edge legal research database. Thus, we are unable to comment on whether all misplaced screws, particularly when asymptomatic, should be revised in an effort to prevent 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. Fortunately, most of the complications were minor and transient. Screws penetrating the anterior cortex and abutting vascular structures, particularly aortic abutment with left-sided screws, which can lead to erosion and pseudoaneurysms. It should be used by experienced and qualified surgeons who are aware of the pitfalls associated with its use. [] The accuracy for free-hand screw placement technique varies from 69% to 94%. Clin Orthop 115:130139, 1976. 1 To be effective, the pedicle screw constructs must withstand intraoperative loading and physiological forces due to daily postoperative activities. Several limitations should be carefully considered when interpreting our results. 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. The link was not copied. Crawford MJ, Esses SI: Indications for pedicle fixation: Results of NASS/SRS faculty questionnaire: North American Spine Society and Scoliosis Research Society. Error in trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults, Spinal fusion in the United States: analysis of trends from 1998 to 2008, Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws, The accuracy of pedicle screw placement using intraoperative image guidance systems, 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, 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, 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, Accuracy and workflow of navigated spinal instrumentation with the mobile AIRO, 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, Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison, Verdict/Settlement Search and Inclusion/Exclusion Criteria, Plaintiff Claim and Index Surgery Information, Impact of Medical Malpractice on Neurosurgeon and Orthopedic Surgeon Careers, Financial Burden of Medical Malpractice Claims Related to Misplaced Pedicle and/or Lateral Mass Screws, Frequency of Misplaced Pedicle and Lateral Mass Screws in Spine Surgery, Strategies to Improve the Accuracy of Screw Placement in Spine Surgery, Top 25 Cited Gamma Knife Surgery Articles - Trigeminal Neuralgia, Top 25 Cited Gamma Knife Surgery Articles - Volume 111, https://doi.org/10.3171/2020.8.FOCUS20600, https://www.bls.gov/data/inflation_calculator.htm, Volume 49 (2020): Issue 5 (Nov 2020): Medicolegal issues in neurosurgery, Single vs multiple misplaced screw(s), no. South Med J 62:17, 1969. 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. Intraoperative and postoperative complications were recorded by the authors and the results were evaluated by an independent observer. Whitecloud et al 35 reported an overall 45% rate of minor and major complications, with the rate of complications increasing to 63% in patients who had previous lumbar surgery. 38. J Spinal Disord Tech. single homes for sale in lehigh valley, pa single homes for sale in lehigh valley, pa Home Realizacje i porady Bez kategorii single homes for sale in lehigh valley, pa 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. The accuracy of pedicle screw placement using intraoperative image guidance systems. J Neurosurg Spine. 4. 1. Agarwal N, Gupta R, Agarwal P, et al. Studdert DM, Mello MM, Sage WM, et al. 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 Bone Joint Surg 62A:13021307, 1980. Spine 6:263267, 1981. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Edwards CC: Spinal screw fixation of the lumbar and sacral spine: Early results treating the first 50 cases. 16. Malpractice litigation following spine surgery. Pedicle screw instrumentation is widely used for the stabilization of the subaxial cervical, thoracic, and lumbar spine. J Neurosurg Spine. Defendant-awarded cases by US region (right). PMC Ultimately, no significant differences were seen in inflation-adjusted award information between plaintiff and defendant (Table 3). 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. 2007;106(6):11081114. The site is secure. Spine arthrodesis was evaluated with plain AP and lateral radiographs taken 1 year after surgery. J Spine Surg. 2014;75(6):609613. What can spine surgeons do to improve patient care and avoid medical negligence suits? Of note, the award amount for one settlement case was undisclosed. J Bone Joint Surg 54A:11951204, 1972. Re: malpositioned pedicle screw resulting in additional surgery and disability. One of the patients had a late wound infection develop that was treated by radical debridement and removal of instrumentation. pedicle screw: A rigid surgical implant used to stabilize adjacent spinal segments in spinal fusion surgery. Nottmeier EW, Seemer W, Young PM. Mukherjee S, Pringle C, Crocker M. A nine-year review of medicolegal claims in neurosurgery. J Neurosurg Spine. For more information, please refer to our Privacy Policy. 7. J Bone Joint Surg 45A:11591170, 1963. Quinnell RC, Stockdale HR: Some experimental observations of the influence of a single lumbar floating fusion on the remaining lumbar spine. 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. When grouped by US region, most cases occurred in the Northeast (n = 25, 36.8%), followed by the West (n = 15, 22.1%; Fig. 34. 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. 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. 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. Unauthorized use of these marks is strictly prohibited. Bethesda, MD 20894, Web Policies 144 Wiltse LL, Spencer CW: New uses and refinements of the paraspinal approach to the lumbar spine. 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. NCI CPTC Antibody Characterization Program. Drafting the article: Sankey. Spine (Phila Pa 1976). Spine neurosurgeons facing the judicialization of their profession: disenchantment and alteration of daily practicea qualitative study. Spine 13:952953, 1988. Rynecki ND, Coban D, Gantz O, et al. Schlegel JD, Smith JA, Schleusener RN: Lumbar motion segment pathology adjacent to thoracolumbar, lumbar, and lumbosacral fusions. Presse Med 78:14471448, 1970. Pedicle screw placement safety with the aid of patient-specific guides in a case series of patients with thoracic scoliosis. Lali Sekhon, Jocelyn Idema & more: 4 spine and neurosurgeons making headlines, Spinal cord stimulation trumps medication for pain reduction 7 takeaways, Dr. Khalid Kurtom on major trends in spinal cord injury surgery. A total of 69 patients (mean age, 67.416 . Each side was judged separately. (A) Anteroposterior and (B) lateral radiographs taken 2 years after surgery show unilateral pseudarthrosis in a 55-year-old man with spinal stenosis. Am J Transl Res. 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. And while the offending screw was removed the next day, Nyquist continued to experience right foot drop, along with lower back pain and sciatica, i.e. 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.