26 They support that after a lengthy symptom-free period, segments next to a fused segment can break down and the segment next to the adjacent segment is almost as likely to break down as the adjacent segment. Larson AN, Santos ER, Polly DW Jr, Ledonio CG, Sembrano JN, Mielke CH, Guidera KJ. This step in implant evolution was inevitable, because prior phases of implant development did not control each plane of motion segment stress. Spine (Phila Pa 1976). 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). Pedicle screw fixation is an effective but demanding method to treat various spinal disorders and is associated with a significant complication rate. Quraishi NA, Hammett TC, Todd DB, et al. government site. Defensive medicine in U.S. spine neurosurgery. Screw Malposition: Are There Long-term Repercussions to Malposition of Pedicle Screws? Spine 8:970981, 1996. Screw misplacement. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement. Sub-analysis of adolescent idiopathic scoliotic patients showed no curve or patient characteristic that correlated with IMP or SAR. Three slender patients complained of soft tissue irritation and a bothersome prominence because of the screws bulky profile. + 48 696 042 504. This study revealed an overall accuracy rate of 95.2% of mainly percutaneously inserted pedicle screws according to the classification of Zdichavsky et al. 4). J Neurosurg. 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. All Rights Reserved. 35. Under the high-low agreement, Drs. Spine 18:18621866, 1993. The total number of reoperations for MPS and patient clinical data were obtained from medical records at each hospital. were excluded from analysis. 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). 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. 2022 Sep 15;14(9):6323-6331. eCollection 2022. Moffatt-Bruce SD, Ferdinand FD, Fann JI. Spinal fusion in the United States: analysis of trends from 1998 to 2008. 8. Bookshelf Edwards CC: Spinal screw fixation of the lumbar and sacral spine: Early results treating the first 50 cases. Neurosurgery. The third surgical procedure removed the pedicle screws but left the patient in an unfused state with an unstable spine. Int Orthop 20:3542, 1996. 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. Spine 13:10121018, 1988. Intraoperative pedicle fractures requiring further points of fixation. The cost of defensive medicine on 3 hospital medicine services. [] The accuracy for free-hand screw placement technique varies from 69% to 94%. Phone/Fax: 30-2810-318361; E-mail: [emailprotected]. Each case was then carefully screened for relevance and sufficient data. All case demographics are summarized in Table 1. 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. 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. doi: 10.1097/BPO.0000000000001828. Orthop Trans 11:99, 1987. 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. There were two complete degenerations of the upper disc, one central canal stenosis, and two asymptomatic disc space narrowings and retrolistheses. CT-navigation versus fluoroscopy-guided placement of pedicle screws at Two patients with associated injuries in the lower limbs had deep venous thrombosis develop, three patients had pneumonia develop, and four patients with neurologic impairment had urinary tract infections develop. Drs. 2012;37(1):6776. Hardware-related failures were observed in 12 patients (10.7%). 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. 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. This patient recovered completely in 6 weeks. In White AH, Rothman RH, Ray CD (eds). The link was not copied. Forty-seven intraoperative and medical complications were observed in 41 patients (36.6%). With pedicle shapes and sizes varying wildly in the scoliotic spine, misplacement of a screwas well as and under- or oversizingare real possibilities in spine surgery. Accuracy and workflow of navigated spinal instrumentation with the mobile AIRO CT scanner. 19. This demonstrates technical ability but does not represent the impact of screw misplacement on individual patients. J Neurosurg Spine. 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. The https:// ensures that you are connecting to the Results. Also notable, only one claim reported the use of intraoperative CT and was ultimately ruled in favor of the defendant. Epub 2014 Jun 13. Junctional problems were recorded as pathologic changes of the adjacent motion segments, just above and below the instrumented and fused segments. 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. You may be trying to access this site from a secured browser on the server. Neurological outcome and management of pedicle screws - PubMed Mohar J, Vali M, Podovovnik E, Mihali R. Eur Spine J. Can Postoperative Radiographs Accurately Identify Screw Misplacements? Hardware problems were those related to the physical change of metal and screw position. The patient had to undergo a subsequent surgery to remove the pedicles. Koktekir E, Ceylan D, Tatarli N, Karabagli H, Recber F, Akdemir G. Spine J. Therefore, when instrumentation is to be used, the benefits must outweigh the risks. Spine 18:11601172, 1993. 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. 2011;306(10):1088. Erwin WD, Dickson JH, Harrington PR: Clinical review of patients with broken Harrington rods. Thoracic Pedicle Screws - ScienceDirect St Louis, CV Mosby 322327, 1987. When grouped by US region, most cases occurred in the Northeast (n = 25, 36.8%), followed by the West (n = 15, 22.1%; Fig. 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. At the lumbosacral area, breakage of a divergent screw of a Chopin block occurred on only one side with no loss of correction. True accuracy of percutaneous pedicle screw placement in thoracic and Spine 13:696706, 1988. 2011;365(7):629636. Median screw misplacement rate was 10% in group A and 13% in group B. Spine 6:615619, 1981. Neurologic injury. Recently, robot-assisted pedicle screw implantation has been increasingly utilized at large-volume academic centers. 18. As compared to cases in 19952009, those in 20102019 resulted in a significantly higher average nominal payout to plaintiffs ($776,439 $74,460 vs $1,506,000 $385,527, p = 0.028). Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. Melissa Nyquist required a lumbar back fusion for a herniated disc at the L4-5 level. Long spine fixation was necessary for patients with tuberculous spondylitis and metastatic disease. 2016;124(5):15241530. Quinnell RC, Stockdale HR: Some experimental observations of the influence of a single lumbar floating fusion on the remaining lumbar spine. Mississippi Appellate Court Affirms Medical Malpractice Defense Verdict One of the patients had a late wound infection develop that was treated by radical debridement and removal of instrumentation. Saillant G: Etude anatomique des pedicules vertebraux: Application chirurgicale. Svider PF, Husain Q, Kovalerchik O, et al. This occurred on only one side and the correction achieved by the instrumentation was maintained. 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. 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. Epstein NE. All of these patients were asymptomatic and had satisfactory final clinical outcomes (Fig 2). pedicle screw misplacement malpractice 30. The remaining eight patients, including two patients with spinal trauma, five patients with infection, and one patient with a tumor, had anterior and posterior procedures. Your current browser may not support copying via this button. Background The objective of this cadaveric study was to analyze the effects of iatrogenic pedicle perforations from screw misplacement on the mean pullout strength of lower thoracic and lumbar pedicle screws. Spine J. Copyright © 2023 Becker's Healthcare. 2014;21(3):320328. Jury awards $4.5M over misplaced pedicle screw during spine surgery: 5 Call Us Now For a Free Consultation | Toll Free: 800.583.8002 | Local: 312.346.0045, Cook County Surgeons Cut Common BIle Duct During Surgery, But Jury Finds for Defendants , Illinois Jury Finds in Favor of Doctor in Gallbladder Surgery that Led to Fatal Bowel Perforation , Debate Over Extent of Eye Damage Following Implant Lens Surgery Leads to $1 Million Verdict in, $75 Million Jury Verdict in Failure to Timely Diagnose Stroke, $18 Million Jury Verdict in Late Diagnosis of Breast Cancer, $300,000 Settlement for Excessive Use of Radiation, Chicago Medical Malpractice Lawyer Kreisman Law Offices Home, Contact Illinois Personal Injury Attorney Kreisman Law Offices. 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. 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. 16,24,28 Simultaneously, the evolution of the surgical techniques has led to increased procedural safety. $2 Million Spinal Surgery Case Against Neurosurgeon and Hospital Ultimately, no significant differences in case demographics were found between plaintiff and defendant judgments (Table 1). 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. Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. Clipboard, Search History, and several other advanced features are temporarily unavailable. Epub 2014 Apr 4. Pitfall: Unstable injuries. 3. It is easier to confuse a jury than convince a judge: the crisis in medical malpractice. Plaintiff award amounts were adjusted for inflation as of April 2020 using an online inflation calculator provided by the US Bureau of Labor Statistics (https://www.bls.gov/data/inflation_calculator.htm). Rovit RL, Simon AS, Drew J, et al. Todd NV. 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. 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. Per-patient analysis reveals more concerning numbers toward screw misplacement. Lumbosacral pedicle screw placement using a fluoroscopic pedicle axis (A) Anteroposterior and (B) lateral radiographs show coronal imbalance that developed 4 years after surgery in a 57-year-old woman with L3L4 float fusion. 12. Pedicle screw placement: Robotic assistance for greater precision Aigner R, Bichlmaier C, Oberkircher L, Knauf T, Knig A, Lechler P, Ruchholtz S, Frink M. BMC Musculoskelet Disord. Illinois Jury Finds in Favor of Doctor in Gallbladder Surgery that Led to Fatal Bowel Perforation Nickl v. Barry S. Rosen, M.D. Harrington PR, Tullos HS: Reduction of severe spondylolisthesis in children. 23. 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. 20th Annual Spine, Orthopedic & Pain Management-Driven ASC Conference, 8th Annual Health IT + Digital Health + RCM Conference, 29th Annual Meeting - The Business & Operations of ASCs, The issues spine surgeons are advocating for outside of the operating room, Centinel Spine is now covered by all major payers, What's next for SI joint fusion? Unable to load your collection due to an error, Unable to load your delegates due to an error. Conception and design: Sankey, KD Than. Acquisition of data: Sankey. 2018;43(14):984990. J Neurosurg Spine. Lawsuit information regarding the plaintiffs age at the time of the malpractice claim, sex, postoperative complaint, indication for index surgery, defendant surgeon specialty (neurosurgery vs orthopedics), and delayed diagnosis or treatment, as well as case location by state and case year, was obtained. Rajaee SS, Bae HW, Kanim LE, Delamarter RB. In two patients in the current series, dislodgement of the rods from tulip screws occurred, as reported originally by Edmunds et al. Misplacement rates have been reported to be from 5 to 41% in the lumbar spine and from 3 to 55% in the . Hsu K, Zucherman JF, White AH: Internal Fixation With Pedicle Screws. (A) Anteroposterior and (B) lateral radiographs taken 2 years after surgery show unilateral pseudarthrosis in a 55-year-old man with spinal stenosis. The median time to case closure was longer for defendant-awarded cases, but this finding was not statistically significant (61.5 vs 56.3 months, p > 0.05). Feb. 16, 2021 Accurate placement of pedicle screws is key to avoiding the potential complications of spinal fusion surgery and improving overall spinal fixation. Guillain A, Moncany AH, Hamel O, et al. The standard imaging technique for pedicle screw insertion is two-dimensional images obtained from C-arm-type X-ray fluoroscopy. Determining legal responsibility in otolaryngology: a review of 44 trials since 2008. 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 Sep;21(3):320-8. doi: 10.3171/2014.5.SPINE13567. After the removal of duplicates, a total of 68 unique cases met our inclusion criteria and were included for analysis. 3. They both had motor deficits from which 1 patient recovered completely. An official website of the United States government. Mayo Clinic uses the latest robot-assisted technology when indicated to enhance surgical precision in these procedures. shooting in valdosta leaves one dead 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. Yuan HA, Garfin SR, Dickman CA, Mardjetko SM: A historical cohort study of pedicle screw fixation in thoracic, lumbar and sacral spinal fusions. 2012;89(10):7071. Pedicle screw placement accuracy impact and comparison between grading 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. 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. 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. 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. It has a great developing technique that is used for fixation and fusion in spine surgery. Reoperation for Misplaced Pedicle Screws: A Multicenter Retrospec Nahed BV, Babu MA, Smith TR, Heary RF. However, the misplacement of pedicle screws can lead to disastrous complications. 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). Problems at the junctions of the instrumented spine were seen in five patients (4.5%). $ = US$; MW = Midwest; NE = Northeast; SE = Southeast; SW = Southwest; W = West. 2007;106(6):11081114. McLaughlin WM, Donnelley CA, Yu K, Gillinov SM, Tuason DA. Accuracy of C2 pedicle screw placement using the anatomic freehand J Bone Joint Surg 73A:11791184, 1991. Friedlander and Bradley will pay half of the $2.25 million. Please try after some time. The third patient, who had central spinal stenosis, was treated by decompression alone. Spine 18:23252326, 1993. Two patients had an acute infection develop for which they required operative intervention with irrigation and debridement. Wolters Kluwer Health 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. 2020;45(2):E111E119. J Neurosurg. Minimizing Pedicle Screw Pullout Risks: A Detailed Biomechan Pedicle screw accuracy in thoracolumbar fractures- is routine 2011;24(1):1519. Copyright 1944-2023 American Association of Neurological Surgeons, Copy this link, or click below to email it to a friend. Cotrel Y, Dubousset J, Guillaumat M: New universal instrumentation in spinal surgery. Over 40% of patients had screws with either some/major concern. and 17.1% of the patients included had at least one screw misplaced. Pedicle screw accuracy in thoracolumbar fractures- is routine postoperative CT scan necessary? We avoid using sharp automated drilling, and probe fully the pedicle cavity to prevent nerve root impairment. 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. A total of 2396 screws were placed accurately (87.96%). J Neurosurg Spine. Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. Spine 19:25842589, 1994. In 2 patients, misplacement of pedicle screws was recognized intraoperatively and all implants were removed. Pedicle screw insertion techniques: an update and review of the Both of these patients complained of thigh pain but refused any additional surgery. 8600 Rockville Pike This decision must be made on a case-by-case basis at the surgeons and patients discretion after a thorough discussion of the associated risks and benefits of revision surgery. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. 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. The medicolegal impact of misplaced pedicle and lateral mass screws on Misplacement of Pedicle Screws Leads to Years of Pain and Opioid Addiction Nationally Recognized Regionally Dominant Contact Us Now For a Free Consultation Over $850 Million in Verdicts and Settlements Home Articles Misplacement of Pedicle Screws Leads to Years of Pain and Opioid Addiction Characteristics of medicolegal cases related to misplaced screws in spine surgery. Steinmann JC, Herkowitz HN: Pseudarthrosis of the spine. Defendant-awarded cases by US region (right). 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. Placement of the pedicle screws in the thoracolumbar and lumbar spine is a technically demanding procedure. 25. Retrospective Computed Tomography Scan Analysis of Percutaneously Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort. SECTION I SYMPOSIUM: Advances in Spine Surgery, Distribution of Spinal Disorders in 112 Patients, Classification of Complications in 64 patients. 37. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? PURPOSE This study aimed to compare rates of perioperative complications between robotic-assisted and conventional . Similarly, the highest inflation-adjusted amount awarded ($2,302,472) for pseudarthrosis was attributed to a medially breached pedicle screw during an L5S1 fusion that was determined to have caused the failed union and subsequent need for revision surgery. This site needs JavaScript to work properly. 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. Call me tomorrow. (PDF) Lumbosacral pedicle screw placement using a fluoroscopic pedicle Wiltse LL, Spencer CW: New uses and refinements of the paraspinal approach to the lumbar spine. Epstein NE. . Statistical analysis: Sankey. Please try again soon. Clin Orthop 115:130139, 1976. 0 attorneys agreed. HHS Vulnerability Disclosure, Help The average followup was 35 months (range, 1851 months). There were no observed cases of screw misplacement outside the pedicle on routine AP and lateral radiographs. Plaintiff-awarded cases by US region (left). Complications were classified as general, hardware-related, problems associated with the instrumented segments, junctional level problems, and problems related with balance (Table 2). Abstract BACKGROUND CONTEXT Surgeons have increasingly adopted robotic-assisted lumbar spinal fusion due to indications that robotic-assisted surgery can reduce pedicle screw misplacement. Potential complications may include increased pain, infection, or mechanical . Except for two patients with spinal metastatic disease, all other patients received an iliac crest autologous bone grafts. Administrative/technical/material support: Mehta, Wang, KD Than. Linking and Reprinting Policy. J Spinal Disord Tech. Bydon M, Xu R, Amin AG, Macki M, Kaloostian P, Sciubba DM, Wolinsky JP, Bydon A, Gokaslan ZL, Witham TF. 2018;27(9):23392347. Once the spine is exposed, the appropriate levels of fixation are confirmed with the image intensifier. 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. All the operations were done by one surgeon (PK). Finally, considering the problems of balance, it seems that failure to properly evaluate any preexisting scoliosis was a main cause of this important complication. 2. One hundred twelve patients were treated using the Cotrel-Dubousset pedicle screw fixation system for degenerative disease (57 patients), trauma (42 patients), infection (eight patients), and tumor (five patients) of the lumbar or thoracolumbar spine. Spine 15:1114, 1990. Spine 24:23522357, 1999. 2006;65(4):416421. J Bone Joint Surg 45A:11591170, 1963. The average age of the patients was 47 years and the average followup was 35 months. However, the medicolegal impact of misplaced screws on spine surgery has not been directly reported in the literature. PDF Intraoperative biomechanics of lumbar pedicle screw loosening following single homes for sale in lehigh valley, pa 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. 21. Segal J. 33. doi: 10.1097/BRS.0b013e31822a2e0a. 2014;96(4):266270. PMC 32. Per-patient analysis showed 23 (18.11%) of patients had all screws AP.