Show more. Clin Orthop 284:8090, 1992. However, the misplacement of pedicle screws can lead to disastrous complications. To evaluate the accuracy of pedicle screw placement using a novel classification system to determine potentially significant screw misplacement. Roy-Camille R, Saillant G, Mazel C: Internal fixation of the lumbar spine with pedicle screw plating. Amount awarded to plaintiffs by US region, adjusted for inflation as of April 2020. A neurologic deficit developed in one patient (0.9%) who had partial bilateral drop feet after reduction of L4L5 spondylolisthesis. Critically revising the article: all authors. 8. Spine (Phila Pa 1976). Screws penetrating the anterior cortex and abutting vascular structures, particularly aortic abutment with left-sided screws, which can lead to erosion and pseudoaneurysms. Operative information including fusion level, number of levels fused, level of misplaced screw(s), single versus multiple misplaced screw(s), presence of known CSF leakage, and primary injury due to screw misplacement was also collected. J Bone Joint Surg 54A:11951204, 1972. Lumbar Spine Surgery. They both had motor deficits from which 1 patient recovered completely. All these problems were observed only just above the upper instrumentation level and all were observed in patients older than 55 years. Edwards CC: Spinal screw fixation of the lumbar and sacral spine: Early results treating the first 50 cases. However, this difference was no longer significant when adjusted for inflation ($1,016,000 $90,875 vs $1,630,000 $422,405, p = 0.09). Clinical Orthopaedics and Related Research411:86-94, June 2003. 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 remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. 2012;7(6):e39237. Cook County Surgeons Cut Common BIle Duct During Surgery, But Jury Finds for Defendants Irwin v. Alan Loren, M.D. Copyright 1944-2023 American Association of Neurological Surgeons, Copy this link, or click below to email it to a friend. Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. Epub 2021 Aug 28. 2022 Sep 15;14(9):6323-6331. eCollection 2022. + 48 696 042 504. 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. Malpractice litigation and the spine: the NHS perspective on 235 successful claims in England. 2018;83(5):9971006. pedicle screw: A rigid surgical implant used to stabilize adjacent spinal segments in spinal fusion surgery. Svider PF, Kovalerchik O, Mauro AC, et al. Forty-seven intraoperative and medical complications were observed in 41 patients (36.6%). 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. Except for the patient with an infected pseudarthrosis who had a flat back syndrome (sagittal imbalance) develop, coronal imbalance was observed in five patients (4.5%), and ranged from 7.5 to 12 (Fig 3). 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. FOIA Spine 14:472476, 1989. Hadjipavlou A, Enker P, Dupuis P, Katzman S, Silver J: The causes of failure of lumbar transpedicular spinal instrumentation and fusion: A prospective study. 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. Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. Your current browser may not support copying via this button. Although the rate of the reported medical complications was high (36.5%), these did not significantly affect the final clinical outcome of the current patients. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. 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. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiffs spine. Mason A, Paulsen R, Babuska JM, et al. The average age of the patients was 47 years and the average followup was 35 months. J Spinal Disord Tech. Thirty-five (27.56%) had IMP and 18 (14.17%) had SAR. True accuracy of percutaneous pedicle screw placement in thoracic and Hsu K, Zucherman JF, White AH: Internal Fixation With Pedicle Screws. Ahmadi SA, Sadat H, Scheufler KM, et al. Complete degeneration of the upper disc developed in two patients who had spinal stenosis and degenerative scoliosis. Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003. Routine CT scans were taken in all patients. A misplacement rate of more than 20 % (129 misplaced screws out of 608) seems to be unacceptable compared to only 4.5 % misplacements when using CT-navigation leading to the conclusion that pedicle screw instrumentation in the middle and upper thoracic area should be carried out with the help of navigation only. Krag MH, Beynnon BD, Pope MH, et al: An internal fixator for posterior application to short segment of the thoracic, lumbar, or lumbosacral spine. 10. 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). Accuracy of C2 pedicle screw placement using the anatomic freehand technique. It was firstly introduced by Harrington and Tullos in 1969 and then in late 1980s developed by Roy Camille et al., Louis, and Steffe. Edmunds I, Cummine J, Fearnside M: Prevention of dislodgement of Cotrel-Dubousset rods from tulip screws. leg pain. 2. sharing sensitive information, make sure youre on a federal Fager CA. Copyright © 2023 Becker's Healthcare. 2,24,28,36. Dr. Shaffrey has received grants from the NIH and Department of Defense. Pedicle screw placement accuracy impact and comparison between grading What can spine surgeons do to improve patient care and avoid medical negligence suits? Thus, we are unable to comment on whether all misplaced screws, particularly when asymptomatic, should be revised in an effort to prevent litigation. Two-dimensional (2D) fluoroscopy-guided percutaneous pedicle screw (PPS) placement is currently the most widely applied instrumentation for minimally invasive treatment of spinal injuries requiring stabilization. George Sapkas, MD, DSc; and Panayiotis J. Papagelopoulis, MD, DScGuest Editors. Would you like email updates of new search results? The initial search using the terms above returned 3654 cases. Forty-seven general complications were seen in 41 patients (36.5%). Misplaced pedicle and lateral mass screws result in a considerable risk of malpractice litigation against spine surgeons. 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. Spine 15:1114, 1990. 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. 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. Am J Transl Res. Hardware problems were those related to the physical change of metal and screw position. Don't jump in get legal help. These complications may have resulted from powerful bending movement acting on the screw at its entry point to the bone. 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. $2 Million Spinal Surgery Case Against Neurosurgeon and Hospital Balch CM, Oreskovich MR, Dyrbye LN, et al. 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. In their meta-analysis of nine randomized controlled trials, Li et al. 5. This step in implant evolution was inevitable, because prior phases of implant development did not control each plane of motion segment stress. Recently, robot-assisted pedicle screw implantation has been increasingly utilized at large-volume academic centers. A total of 69 patients (mean age, 67.416 . Drs. Pedicle screw insertion in the thoracolumbar spine. Sethi MK, Obremskey WT, Natividad H, et al. Figure 1: Lower thoracic pedicles provide the firm purchase of the pedicle screw from a lateral starting point and 10-15 degrees convergent angle Surgical technique "Free Hand" pedicle screw placement [50] Our "Free Hand" technique is equivalent for lumbar and Percentage of cases per US region (center). The majority of plaintiffs were male (n = 44, 64.7%), and the median age among all cases was 46 years (range 3757 years). First, this is a retrospective analysis of cases obtained from the web-based Westlaw Edge legal research database. 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%). J Neurosurg Spine. Delayed open treatment of aortic penetration by a thoracic pedicle While the majority of verdicts are found in favor of the defendant (surgeon), over 30% of cases in this study were found in favor of the plaintiff (patient), resulting in average inflation-adjusted payouts of over $1.2 million per claim over the past 25 years. 2012;21(suppl 2):S196S199. Eur Spine J. Each side was judged separately. 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J Pediatr Orthop. Nayar G, Blizzard DJ, Wang TY, et al. 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. Harrington PR, Tullos HS: Reduction of severe spondylolisthesis in children. 1. Despite this problem, the clinical result was excellent. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. 2020;11:38. A large number of studies have reported that in conventional thoracolumbar surgery, compared with traditional freehand screw placement, the accuracy of intraoperative pedicle screw placement has been improved with O-arm intraoperative navigation technology. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? Grubb SA, Lipscomb HJ: Results of lumbosacral fusion for degenerative disc disease with and without instrumentation: Two- to five-year follow-up. All the operations were done by one surgeon (PK). 2017;31(3):287288. At the lumbosacral area, breakage of a divergent screw of a Chopin block occurred on only one side with no loss of correction. Nottmeier EW, Seemer W, Young PM. None of these complications resulted in additional surgery or in a significant increase of morbidity. The standard imaging technique for pedicle screw insertion is two-dimensional images obtained from C-arm-type X-ray fluoroscopy. Disc space narrowing was the most common problem after instrumented arthrodesis and was observed in 27 patients (24.1%). 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. Abstract BACKGROUND CONTEXT Surgeons have increasingly adopted robotic-assisted lumbar spinal fusion due to indications that robotic-assisted surgery can reduce pedicle screw misplacement. Studies have shown that the greatest proportion of malpractice claims in spine surgery are related to procedural error,10,11,14,16,17,19 often resulting in the highest payouts.11,20 For spine surgery, one common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass screws, which occurs in approximately 14%55% of cases using standard techniques and results in neurological injury and/or durotomy in approximately 1%8% of cases.21 Misplaced screws have the potential to cause severe and sometimes permanent neurological deficits, including spinal cord and/or nerve root injury,21 as well as to decrease the stability of the fusion construct, leading to delayed complications related to pseudarthrosis. Spine 17:834837, 1992. EOS System Courtesy of EOS imaging. In 2 patients, misplacement of pedicle screws was recognized intraoperatively and all implants were removed. Fortunately, most of the complications were minor and transient. 15. 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. Pediatric pedicle screw placement using intraoperative computed tomography and 3-dimensional image-guided navigation. The .gov means its official. 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. 8,24,25,32. 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). Rovit RL, Simon AS, Drew J, et al. The intent is to provide relief from pain and nerve damage. 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. When grouped by US region, most cases occurred in the Northeast (n = 25, 36.8%), followed by the West (n = 15, 22.1%; Fig. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. Accuracy of C2 pedicle screw placement using the anatomic freehand Pedicle screw placement: Robotic assistance for greater precision 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. Pedicle screw fixation is an effective but demanding method to treat various spinal disorders and is associated with a significant complication rate. Problems in the instrumented segments were considered those occurring from narrowing of the disc space greater than 3 mm, pseudarthrosis, and loss of reduction. 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. 2018;28(2):186193. Spine 8:970981, 1996. 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. INCLUDE WHEN CITING DOI: 10.3171/2020.8.FOCUS20600. Several studies have shown that spine surgery is at the highest risk for litigation among the surgical subspecialties.12,29 The majority of claims are related to technical and procedural errors,29 including misplaced pedicle and/or lateral mass screws. 13. 70% of Pedicle Screws are misplaced - orthostreams.com 2011;365(7):629636. Risk Factors for the Drift Phenomenon in Oarm NavigationAssisted Unilateral nonunion was seen in three patients (2.7%), associated with implant failure in one of the patients.