Nottmeier EW, Seemer W, Young PM. Both of these patients complained of thigh pain but refused any additional surgery. Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. This study revealed an overall accuracy rate of 95.2% of mainly percutaneously inserted pedicle screws according to the classification of Zdichavsky et al. 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). However, the defendant doctor maintained that Nyquists foot drop was not caused by the misplaced screw. Pedicle screws have been used to treat spinal disorders, including those caused by spinal cancer, congenital anomalies, trauma, and chronic pain syndromes. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. Spine arthrodesis was evaluated with plain AP and lateral radiographs taken 1 year after surgery. Stauffer RN, Coventry MB: Posterolateral lumbar-spine fusion: Analysis of the Mayo clinic series. Despite these failures, solid spinal arthrodesis was obtained in all patients. Potential complications may include increased pain, infection, or mechanical . 14. Health Aff (Millwood). However, the highest offer had been a combined $300,000 from the two defendants. South Med J 62:17, 1969. Orthop Trans 11:99, 1987. Rothberg MB, Class J, Bishop TF, et al. 16,24,28 Simultaneously, the evolution of the surgical techniques has led to increased procedural safety. Complications were classified as general, hardware-related, problems associated with the instrumented segments, junctional level problems, and problems related with balance (Table 2). Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort. to maintaining your privacy and will not share your personal information without J Bone Joint Surg 61A:201207, 1979. 3. 2022 Dec;31(12):3544-3550. doi: 10.1007/s00586-022-07427-0. Kreisman Law Offices has been handling Illinois surgical error lawsuits for individuals and families for more than 35 years in and around Chicago, Cook County and surrounding areas, including Batavia, Bellwood, Deerfield, Evanston, Franklin Park, and Lansing. 2012 Feb 1;37(3):E188-94. Similar to our findings, prior studies have shown that settlements result in lower payouts than cases that are ultimately taken to trial,7,14,15,30 with awards ranging from $125,000 to $9,000,000 compared to $134,000 to more than $38,000,000.7,15 Nevertheless, the true financial toll on spine surgery is largely unknown given that 85% of cases are dismissed or settled out of court, with undisclosed amounts.14 Likewise, substantial time is spent and costs, including legal and administrative, are incurred before judgment, as noted above. In the other patient, L4L5 float arthrodesis was done. Finally, considering the problems of balance, it seems that failure to properly evaluate any preexisting scoliosis was a main cause of this important complication. FOIA Methods: Among the plaintiff-awarded cases, 13 (61.9%) were decided by jury trial, 7 (33.3%) by settlement, and 1 (4.8%) by arbitration. Except for two patients with spinal metastatic disease, all other patients received an iliac crest autologous bone grafts. Eur Spine J. 16. Although the rate of the reported complications was high, the final outcome of the patients was not affected significantly. Despite this problem, the clinical result was excellent. Defensive medicine in U.S. spine neurosurgery. 2. doi: 10.1097/BRS.0b013e31822a2e0a. 5-7 Materials and Methods This is a retrospective study of kyphotic spondylitis tuberculosis (Stb) patients conducted at Fatmawati General Hospital, Jakarta, Indonesia, through the year 2020-2021. Of note, the award amount for one settlement case was undisclosed. 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%. Each case was then carefully screened for relevance and sufficient data. 2005;293(21):26092617. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. Overall reported screw misplacement is low, but it does not reflect the potential impact on patient morbidity. Hsu K, Zucherman JF, White AH: Internal Fixation With Pedicle Screws. 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). Results. The patient had subsequent coronal imbalance and degeneration of the upper disc. All the incidental dural tears were repaired immediately and produced no clinical sequelae. 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). JAMA Intern Med. Spine (Phila Pa 1976). The majority of screws were misplaced in the lumbar spine for both plaintiff- and defendant-awarded cases (66.7% vs 57.4%, respectively, p = 0.564; Table 1). $ = US$. This retrospective study analyzes the complications and the problems developed during and after pedicle screw fixation in patients with spinal disorders and trauma. Epstein NE. J Neurosurg Spine. Legal liability in iatrogenic orbital injury. The initial search using the terms above returned 3654 cases. Clin Orthop 203:4553, 1986. The third patient, who had central spinal stenosis, was treated by decompression alone. Summary of background data: Arthrodesis was questionable in eight asymptomatic patients (7.1%). demonstrated that the number of hospital discharges for spinal fusion increased 2.4 times (137%) from 174,223 to 413,171 (p < 0.001) between 1998 and 2008.32 The true frequency of malpositioned pedicle and lateral mass screws is likely underestimated in spine surgery given the fact that the majority of misplaced screws, as well as the potential complications related to them, are not reported in practice and may be clinically silent. 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. The total number of reoperations for MPS and patient clinical data were obtained from medical records at each hospital. In unstable injuries, the segments above and below the level of injury may have a different orientation of the pedicle trajectory due to . Under the high-low agreement, Drs. 25. However, we did not observe any screw breakage in patients with a degenerative lumbar spine, and the absence of broken screws in this series is because arthrodesis in almost all patients occurred in situ. 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. 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. 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 Bethesda, MD 20894, Web Policies However, only a few complications were related to a poor clinical outcome. The accuracy rate of pedicle screw (PS) placement varies from 85% to 95% in the literature. Amount awarded to plaintiffs by US region, adjusted for inflation as of April 2020. The pedicle screw system is widely used in spine surgery, and it provides rigid fixation and leads to successful subsequent deformity correction and bony fusion. your express consent. It should be used by experienced and qualified surgeons who are aware of the pitfalls associated with its use. The site is secure. Spine 14:472476, 1989. However, 5-10% of those misplaced screws are cause for concern." "To rectify this, we must have access to imaging devices during the procedure. Accuracy and workflow of navigated spinal instrumentation with the mobile AIRO CT scanner. 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. 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. Dr. Abd-El-Barr is a consultant for Spineology. None of these complications resulted in additional surgery or in a significant increase of morbidity. Comparetto, Esq., 727-328-7900, www.florida-malpractice-lawyers.com. The jury found the defendants liable and allocated 75 percent of the fault to Dr. Friedlander and 25 percent to Dr. Bradley. Over 40% of patients had screws with either some/major concern. Am J Otolaryngol. Retrospective analysis of reasons and revision strategy for failed thoracolumbar fracture surgery by posterior approach: a series of 31 cases. In White AH, Rothman RH, Ray CD (eds). Pedicle screw instrumentation is widely used for the stabilization of the subaxial cervical, thoracic, and lumbar spine. 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. Brodsky AE: Post-laminectomy and post-fusion stenosis of the lumbar spine. Some error has occurred while processing your request. 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. National Library of Medicine 2016;25(3):716723. Saillant G: Etude anatomique des pedicules vertebraux: Application chirurgicale. Subjects were 10,754 patients (73,777 pedicle screws) who underwent PSF at 11 hospitals over 15 years. shooting in valdosta leaves one dead Epub 2021 Aug 28. Seven hundred sixty-three screws were inserted in 138 patients. The purpose of current study was to analyze the complications and problems during and after pedicle screw fixation for various spinal disorders and trauma. Screws penetrating the anterior cortex and abutting vascular structures, particularly aortic abutment with left-sided screws, which can lead to erosion and pseudoaneurysms. The standard imaging technique for pedicle screw insertion is two-dimensional images obtained from C-arm-type X-ray fluoroscopy. Intraoperative and postoperative complications were recorded by the authors and the results were evaluated by an independent observer. 3. 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). Daniels AH, Ruttiman R, Eltorai AEM, et al. Spine 17:349355, 1992. Clin Orthop 115:130139, 1976. 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. Roy-Camille R, Roy-Camille M, Demeulenaere C: Osteosynthese du rachis dorsal, lombaire et lombo-sacre par plaque metalliques vissees dans les pedicules vertebraux et es apophyses articularies. Three-dimensional printing versus freehand surgical techniques in the surgical management of adolescent idiopathic spinal deformity. Procedural errors led to combined payouts totaling $124,943,933 in neurosurgery claims between 2003 and 2012 in a study looking at data from the Physician Insurers Association of America Data Sharing Project.10 However, our study is the first to report the direct medicolegal impact of screw misplacement on US spine surgery, with 30.9% of judgments/settlements in favor of the plaintiff, resulting in average payouts of $1,204,422 $753,832 per claim. + 48 696 042 504. $ = US$; MW = Midwest; NE = Northeast; SE = Southeast; SW = Southwest; W = West. 2021 Jul 1;41(Suppl 1):S80-S86. Previous biomechanical and clinical studies defining junctional segment problems are lacking and consist mainly of case reports. Louw JA, Dommissee GF, Roos MF: Spinal stenosis following anterior spinal fusion. 4. A retrospective review of charts, x-rays (XRs) and computed tomography (CT) scans was performed. 3. 1 To be effective, the pedicle screw constructs must withstand intraoperative loading and physiological forces due to daily postoperative activities. Medical malpractice in orthopedic surgery: a Westlaw-based demographic analysis. Your message has been successfully sent to your colleague. The medical malpractice suit Ayala v. Friedlander, M.D., claimed that a March 2011 lumbar fusion surgery performed by neurosurgeon Marvin Friedlander, MD, and orthopedic spine surgeon Douglas Bradley, MD, strayed from the accepted standards of care because a pedicle screw was placed in the wrong location. Conception and design: Sankey, KD Than. 2011;213(5):657667. 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. This step in implant evolution was inevitable, because prior phases of implant development did not control each plane of motion segment stress. Insuring spinal neurosurgery. 2014;75(6):609613. 1,12,19,22 The largest series of adjacent segment breakdown was reported by Schlegel et al. Spine (Phila Pa 1976). Spine 18:23252326, 1993. 2014;20(6):636643. 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All the operations were done by one surgeon (PK). Dr. Abd-El-Barr is a consultant for Spineology. Two patients had an acute infection develop for which they required operative intervention with irrigation and debridement. 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. In our opinion, these problems may be prevented by applying the following principles: limitation of spine arthrodesis to the pathologic levels, inclusion of already extensive changes at the level above or below the planned arthrodesis into the arthrodesis, restoration of postoperative sagittal and coronal alignment, and avoidance of impingement syndrome from the adjacent nonfused facets. Neurosurgery. 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. Rovit RL, Simon AS, Drew J, et al. and transmitted securely. Smith TR, Hulou MM, Yan SC, et al.