pedicle screw misplacement malpractice
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. 2014 Sep;21(3):320-8. doi: 10.3171/2014.5.SPINE13567. Bydon M, Xu R, Amin AG, et al. Zucherman J, Hsu K, Picetti III G, et al: Clinical efficacy of spinal instrumentation in lumbar degenerative disc disease. Clin Orthop 203:717, 1986. The radiology results showed that the surgical screw placed at the right L4-5 area had breached the medial wall and was actually extending into the spinal canal. Whitecloud III TS, Butler JC, Cohen JL, Candelora PD: Complications with the variable spinal plating system. The contact form sends information by non-encrypted email, which is not secure. A total of 2396 screws were placed accurately (87.96%). PURPOSE This study aimed to compare rates of perioperative complications between robotic-assisted and conventional . Median screw misplacement rate was 10% in group A and 13% in group B. Hsu K, Zucherman JF, White AH: Internal Fixation With Pedicle Screws. Of note, the award amount for one settlement case was undisclosed. Problems at the junctions of the instrumented spine were seen in five patients (4.5%). Spine arthrodesis was evaluated with plain AP and lateral radiographs taken 1 year after surgery. However, 5-10% of those misplaced screws are cause for concern." "To rectify this, we must have access to imaging devices during the procedure. Orthopedics. Cotrel Y, Dubousset J, Guillaumat M: New universal instrumentation in spinal surgery. Harrington and Tullos 11 first reported the technique of transpedicle screw fixation, and Roy-Camille et al 23 popularized the first practical method of pedicle screw fixation. In addition, the median time to judgment is substantial, particularly for defendant verdicts, spanning over 4.5 years from the time of surgery. Taylor CL. 17. This site needs JavaScript to work properly. Accuracy of C2 pedicle screw placement using the anatomic freehand technique. Li HM, Zhang RJ, Shen CL. 13. 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. Statistical analysis: Sankey. Under this theory of liability, the plaintiff needed to not only establish that she had experienced foot drop, a fact that no one was disputing, but that it was caused by the defendants negligence. Schatlo B, Molliqaj G, Cuvinciuc V, et al. The site is secure. Harrington PR, Tullos HS: Reduction of severe spondylolisthesis in children. Spine 16(8 Suppl):S422427, 1991. Studdert DM, Mello MM, Sage WM, et al. South Med J 62:17, 1969. Thirty-five (27.56%) had IMP and 18 (14.17%) had SAR. Epstein NE. 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. Conception and design: Sankey, KD Than. Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. 15. 2016;102(2):358362. 0 attorneys agreed. 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. Although the rate of the reported complications was high, the final outcome of the patients was not affected significantly. A retrospective review of charts, x-rays (XRs) and computed tomography (CT) scans was performed. 39. Am J Orthop. The screws were needed to stabilize the spine and fix the fused vertebrae in place. In situ spine arthrodesis permits load sharing by the vertebral bodies, preventing fatigue failure of the implant. 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). Neurosurgery. Eur Spine J. 2018;43(14):984990. 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). Many technological advances have been made over the past several decades in an effort to improve the accuracy of screw placement in spine surgery.3436 For example, 3D fluoroscopybased image guidance has been shown to decrease the pedicle breach rate in several studies compared to the rate with 2D fluoroscopic guidance or the freehand technique, particularly in deformity and revision surgeries.21,34,36,37 CT guidance or intraoperative confirmation has also been shown to further improve the accuracy of pedicle screw placement,3638 with reported accuracy rates of 89%100% reported in the literature, depending on the authors breach criteria.35 However, it is important to note that the use of this technology is often accompanied by a lower threshold for intraoperative screw revision, sometimes leading to higher rates of replaced screws.33 Arguably, these improved trajectories may avoid iatrogenic neurological deficits due to prolonged nerve root compression or even improve the stability of the construct;34,37 however, prospective studies of long-term outcomes and rates of revision surgery remain sparse in the literature. SECTION I SYMPOSIUM: Advances in Spine Surgery, Distribution of Spinal Disorders in 112 Patients, Classification of Complications in 64 patients. 1 Although this technique has advantages over open instrumentation, it also presents new challenges and specific complications. Disclaimer. 1. PMC J Bone Joint Surg 61A:201207, 1979. In addition, seven (6.3%) dural tears occurred during the decompression and none occurred during instrumentation. 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. Malpractice liability and defensive medicine: a national survey of neurosurgeons. 27. This patient recovered completely in 6 weeks. 2017;31(3):287288. Erwin WD, Dickson JH, Harrington PR: Clinical review of patients with broken Harrington rods. However, published reports are increasingly demonstrative of the positive effect of pedicle fixation on arthrodesis and successful outcome in the treatment of patients with these disorders. 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. There were no observed cases of screw misplacement outside the pedicle on routine AP and lateral radiographs. Gertzbein SD, Robbins SE: Accuracy of pedicular screw placement in vivo. Ultimately, no significant differences were seen in inflation-adjusted award information between plaintiff and defendant (Table 3). Twenty-one patients (18.8%) had thoracolumbar injuries, and loss of immediate postoperative deformity correction ranged from 1.4 to 4.5. FOIA Larson AN, Santos ER, Polly DW Jr, Ledonio CG, Sembrano JN, Mielke CH, Guidera KJ. In the other patient, L4L5 float arthrodesis was done. 2002;27(22):24252430. (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. 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. 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. Call me tomorrow. 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. Spine 6:615619, 1981. A total of 2396 screws were placed accurately (87.96%). 2011;213(5):657667. Screws penetrating the anterior cortex and abutting vascular structures, particularly aortic abutment with left-sided screws, which can lead to erosion and pseudoaneurysms. However, the medicolegal impact of misplaced screws on spine surgery has not been directly reported in the literature. Routine CT scans were taken in all patients. Reviewed submitted version of manuscript: all authors. Accessibility In five patients with thoracolumbar injuries, who were the first treated in the current series, and in four patients with fractures in the lower lumbar spine, two-segment fixation was used. 23. Neurosurgical practice liability: relative risk by procedure type. 2014 Aug 1;14(8):1702-8. doi: 10.1016/j.spinee.2014.03.044. Nominal and inflation-adjusted award payouts were higher for trial verdicts than for settlement/arbitration, with a nominal average of $1,140,473 $841,683 versus $788,533 $306,186 awarded to the plaintiff, respectively (p = 0.30). Comparetto, Esq., 727-328-7900, www.florida-malpractice-lawyers.com. Elizabeth Hofheinz, M.P.H., M.Ed. Balch CM, Oreskovich MR, Dyrbye LN, et al. Your current browser may not support copying via this button. 14. shooting in valdosta leaves one dead J Neurosurg Spine. 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%). Louw JA, Dommissee GF, Roos MF: Spinal stenosis following anterior spinal fusion. 3,4,9,29,34 In addition, developments in surgical technique and implant design have decreased operative risk and implant-related complications. Svider PF, Kovalerchik O, Mauro AC, et al. Fortunately, most of the complications were minor and transient. McAfee PC, Weiland DJ, Carlow JJ: Survivorship analysis of pedicle spinal instrumentation. With increasing pedicle screw usage, the number of patients with misplaced screws will likely increase proportionally. 2 One of the first obstacles regarding . Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003. Scarone P, Vincenzo G, Distefano D, et al. Neurosurgery. Bookshelf Spine 24:23522357, 1999. Bethesda, MD 20894, Web Policies laterally placed screws and the azygous vein on the right (T5-T11). Stauffer RN, Coventry MB: Posterolateral lumbar-spine fusion: Analysis of the Mayo clinic series. reporting that the number of Medicare patients who underwent a complex lumbar spine fusion for spinal stenosis increased 15-fold, from 1.3 persons per 100,000 Medicare persons in 2002 to 19.9 in 2007.31 Similarly, a study by Rajaee et al. On average, physicians spend nearly 11 percent of their 40-year careers with an open, unresolved malpractice claim. Malpractice issues in neurological surgery. Agarwal N, Gupta R, Agarwal P, et al. The instrumentation and bone graft were left in place in these patients (total infection rate, 2.7%). 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. 2016;124(5):15241530. Drafting the article: Sankey. A TLIF is a surgical procedure that attempts to fuse vertebrae in order to stabilize the patient's spine. Spine 17:834837, 1992. Back pain/spinal stenosis and neurogenic claudication/radiculopathy were the most frequently reported indications for the index surgery, accounting for 13 (19.1%) and 11 (16.2%) cases, respectively. Defendant-awarded cases by US region (right). [] The accuracy for free-hand screw placement technique varies from 69% to 94%. The median time to case closure was 56.3 (35.267.2) months when ruled in favor of the plaintiff (i.e., patient) compared to 61.5 (51.477.2) months for defendant (surgeon) verdicts (p = 0.117). 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. A total of 69 patients (mean age, 67.416 . However, only a few complications were related to a poor clinical outcome. Rovit RL, Simon AS, Drew J, et al. Clin Orthop 203:7598, 1986. Misplacement rates have been reported to be from 5 to 41% in the lumbar spine and from 3 to 55% in the . Before Presse Med 78:14471448, 1970. Would you like email updates of new search results? Five patients had uneventful early postoperative course. Determining legal responsibility in otolaryngology: a review of 44 trials since 2008. Junctional problems were recorded as pathologic changes of the adjacent motion segments, just above and below the instrumented and fused segments. Spine J. 30. and transmitted securely. your express consent. 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Sethi MK, Obremskey WT, Natividad H, et al. 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. Epstein NE. 37. Furthermore, 25 patients (22.3%) reported persistent pain in the iliac crest (donor graft site) for several months, for which they were treated with repeated lidocaine injections and analgesics. Eur Spine J. $ = US$; MW = Midwest; NE = Northeast; SE = Southeast; SW = Southwest; W = West. official website and that any information you provide is encrypted Administrative/technical/material support: Mehta, Wang, KD Than. 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. Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort. HHS Vulnerability Disclosure, Help 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. However, the misplacement of pedicle screws can lead to disastrous complications. Pedicle screw accuracy in thoracolumbar fractures- is routine postoperative CT scan necessary? However, the highest offer had been a combined $300,000 from the two defendants. Of note, while only 38.2% (n = 26) of cases in our study mentioned the use of intraoperative radiographic confirmation, only one of these cases reported that the misplaced screw had been caught prior to leaving the operating room, which had resulted in an inadvertent dural tear and L5 nerve root injury. Clinical Orthopaedics and Related Research411:86-94, June 2003. In the current study, the arthrodesis rate of 89.4% compares favorably with other previously reported series in the spinal literature, most of which use radiographic means to access the status of the spinal arthrodesis. These risks can be minimized by the judicious use of instrumentation by experienced surgeons for specific indications as supported by the literature. Dr. Friedlander did not order a CT or MRI until January 2013, when the pedicle screw was found to be in the wrong location and a failed fusion was diagnosed, according to the suit. The accuracy rate of pedicle screw (PS) placement varies from 85% to 95% in the literature. sharing sensitive information, make sure youre on a federal Despite commonly used, questions remain about their safety especially for the thoracic spine and in deformity where difficulty in positioning can lead to pedicle breach and adjacent structures injury. 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. doi: 10.1097/BPO.0000000000001828. 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. Harris RI, Wiley JJ: Acquired spondylolysis as a sequel to spine fusion. Pedicle screw instrumentation is widely used for the stabilization of the subaxial cervical, thoracic, and lumbar spine. A retrospective review of charts, XRs and low-dose CT scans of 127 patients who underwent spinal fusion with pedicle screws for spinal deformity was performed. The patient had to undergo a subsequent surgery to remove the pedicles. 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. Friedlander and Bradley will pay half of the $2.25 million. Summary of background data: 4. The initial search using the terms above returned 3654 cases. Clin Orthop 284:8090, 1992. Linking and Reprinting Policy. 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. Despite this problem, the clinical result was excellent. Spine 18:18621866, 1993. Hardware problems were those related to the physical change of metal and screw position. 33. At the lumbosacral area, breakage of a divergent screw of a Chopin block occurred on only one side with no loss of correction. Quinnell RC, Stockdale HR: Some experimental observations of the influence of a single lumbar floating fusion on the remaining lumbar spine. (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. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiff's spine. Long spine fixation was necessary for patients with tuberculous spondylitis and metastatic disease. Wiltse LL, Spencer CW: New uses and refinements of the paraspinal approach to the lumbar spine. 2014;75(6):609613. Spine 18:11601172, 1993. Critically revising the article: all authors. Smith TR, Hulou MM, Yan SC, 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. However, the defendant doctor maintained that Nyquists foot drop was not caused by the misplaced screw. JAMA. Todd NV. Materials and Methods Sixty . An official website of the United States government. Achieving proper lumbar lordosis, evaluating any preexisting scoliosis, and intraoperative assessment with AP radiographs could prevent balance problems. 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. J Neurosurg. to maintaining your privacy and will not share your personal information without Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison. 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. 3. Amount awarded to plaintiffs by US region, adjusted for inflation as of April 2020. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. 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. Cook County Surgeons Cut Common BIle Duct During Surgery, But Jury Finds for Defendants Irwin v. Alan Loren, M.D. Pedicle instrumentation in the thoracolumbar and lumbar spine is a technically challenging procedure. 18. A total of 2724 screws were placed in 127 patients. National Library of Medicine Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). 4. The rate of medical complications was 8%. Melissa Nyquist required a lumbar back fusion for a herniated disc at the L4-5 level. Please enable it to take advantage of the complete set of features! Methods: 2014;20(2):196203. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. Steffee AD, Biscup RS, Sitkowski DJ: Segmental spine plates with pedicle screw fixation: A new internal fixation device for disorders of the lumbar and thoracolumbar spine. 2018;29(4):397406. The standard imaging technique for pedicle screw insertion is two-dimensional images obtained from C-arm-type X-ray fluoroscopy. J Pediatr Orthop. St Louis, CV Mosby 322327, 1987. Acquisition of data: Sankey. The rod is held in place by "pedicle screws," which the surgeon must insert into the pedicles. Privacy Policy. Wolters Kluwer Health Can Postoperative Radiographs Accurately Identify Screw Misplacements? Malpractice claims in spine surgery in Germany: a 5-year analysis. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? 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. . 6 Methods. Br J Neurosurg. 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. 3. 2022 Jun;8(2):234-241. doi: 10.21037/jss-22-28. Nahed BV, Babu MA, Smith TR, Heary RF. Percentage of cases per US region (center). 2018;83(5):9971006. 1,12,19,22 The largest series of adjacent segment breakdown was reported by Schlegel et al. Despite these failures, solid spinal arthrodesis was obtained in all patients. 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. 2022 Dec;31(12):3544-3550. doi: 10.1007/s00586-022-07427-0. 32. Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. Health Aff (Millwood). 2018;27(9):23392347. JAMA. 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. 2012;37(1):6776. 2012;41(2):6973. 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. Edwards CC: Spinal screw fixation of the lumbar and sacral spine: Early results treating the first 50 cases. Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error.