27. Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. 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. In the other patient, L4L5 float arthrodesis was done. However, the misplacement of pedicle screws can lead to disastrous complications. Rovit RL, Simon AS, Drew J, et al. Results: 2022 Jun;8(2):234-241. doi: 10.21037/jss-22-28. 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. Careers. 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. 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. These numbers are in line with the current literature. Koktekir E, Ceylan D, Tatarli N, Karabagli H, Recber F, Akdemir G. Spine J. Legal liability in iatrogenic orbital injury. Problems at the junctions of the instrumented spine were seen in five patients (4.5%). shooting in valdosta leaves one dead Please try again soon. 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. Therefore, when instrumentation is to be used, the benefits must outweigh the risks. Spine 18:983991, 1993. Each case was then carefully screened for relevance and sufficient data. 2020;162(6):13791387. Two patients had an acute infection develop for which they required operative intervention with irrigation and debridement. Long spine fixation was necessary for patients with tuberculous spondylitis and metastatic disease. 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. What can spine surgeons do to improve patient care and avoid medical negligence suits? Wiltse LL, Spencer CW: New uses and refinements of the paraspinal approach to the lumbar spine. 3,4,9,29,34 In addition, developments in surgical technique and implant design have decreased operative risk and implant-related complications. 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. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiff's spine. The .gov means its official. Once the spine is exposed, the appropriate levels of fixation are confirmed with the image intensifier. Edwards CC: Spinal screw fixation of the lumbar and sacral spine: Early results treating the first 50 cases. MeSH Complete degeneration of the upper disc developed in two patients who had spinal stenosis and degenerative scoliosis. In the current series, there were no cases of screw misplacement or vascular or neurologic complications caused by implant application. 1. In six patients (5.3%) with degenerative spine disease, the disc material had been removed. 2012 Feb 1;37(3):E188-94. 5. J Neurosurg Spine. Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort. may email you for journal alerts and information, but is committed Svider PF, Husain Q, Kovalerchik O, et al. This occurred on only one side and the correction achieved by the instrumentation was maintained. 9. 39. Incidence and costs of defensive medicine among orthopedic surgeons in the United States: a national survey study. pedicle screw misplacement malpractice. J Neurosurg Spine. This retrospective analysis of 68 closed medicolegal cases related to misplaced screws in spine surgery showed that neurosurgeons and orthopedic spine surgeons were equally named as the defendant (n = 32 and 31, respectively), and cases were most commonly due to misplaced lumbar pedicle screws (n = 41, 60.3%). Descriptive analysis of state and federal spine surgery malpractice litigation in the United States. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement. matte black square deadbolt; roberts point park fishing report; qr code on binax covid test; mff premium character list. Eur Spine J. 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. The third patient, who had central spinal stenosis, was treated by decompression alone. Federal government websites often end in .gov or .mil. J Pediatr Orthop. 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. 2018;29(4):397406. Intraoperative and postoperative complications were recorded by the authors and the results were evaluated by an independent observer. A retrospective review of charts, x-rays (XRs) and computed tomography (CT) scans was performed. One of the common means of doing so is to place a screw into each of two adjacent spinal bones (vertebrae), and then a rod between them. This retrospective study analyzes the complications and the problems developed during and after pedicle screw fixation in patients with spinal disorders and trauma. Jena AB, Seabury S, Lakdawalla D, Chandra A. 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. JAMA. 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). Unilateral nonunion was seen in three patients (2.7%), associated with implant failure in one of the patients. Grubb SA, Lipscomb HJ: Results of lumbosacral fusion for degenerative disc disease with and without instrumentation: Two- to five-year follow-up. Plaintiff-awarded cases by US region (left). 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. Spine 18:23252326, 1993. The jury found the defendants liable and allocated 75 percent of the fault to Dr. Friedlander and 25 percent to Dr. Bradley. Pedicle screw fixation is commonly used in spinal instrumentation surgeries to connect rods to vertebrae in order to correct spine alignment, stabilize vertebrae, and reach an arthrodesis. Neurosurgeons and orthopedic surgeons were named as the defendant in an equal number of cases, and the decision for the plaintiff versus the defendant was also similar between specialties. The purpose of current study was to analyze the complications and problems during and after pedicle screw fixation for various spinal disorders and trauma. Adjusted for age and preoperative Cobb angle, patients with a higher misplacement rate were more likely to have screws . Neurologic injury. Malpractice litigation following spine surgery. Bethesda, MD 20894, Web Policies Cerebrospinal fluid fistulas. Three slender patients complained of soft tissue irritation and a bothersome prominence because of the screws bulky profile. All Rights Reserved. Potential complications may include increased pain, infection, or mechanical . The link was not copied. 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. Neurosurgical practice liability: relative risk by procedure type. Study supervision: Goodwin, Karikari, Shaffrey, Abd-El-Barr, KD Than. 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. Statistical analysis: Sankey. 3. 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. Hardware problems were those related to the physical change of metal and screw position. 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. We also investigated the effect of bone mineral density (BMD), diameter of pedicle screws, and the region of spine on the pullout strength of pedicle screws. Recently, robot-assisted pedicle screw implantation has been increasingly utilized at large-volume academic centers. 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. Friedlander and Bradley will pay half of the $2.25 million. Don't jump in get legal help. 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. Both of these patients complained of thigh pain but refused any additional surgery. 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. 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. 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. 22. Clin Orthop 203:7598, 1986. 1. Accuracy of fluoroscopically-assisted pedicle screw placement: analysis of 1,218 screws in 198 patients. The cost of defensive medicine on 3 hospital medicine services. 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. 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. 2,24,28,36. There were two complete degenerations of the upper disc, one central canal stenosis, and two asymptomatic disc space narrowings and retrolistheses. SECTION I SYMPOSIUM: Advances in Spine Surgery, Distribution of Spinal Disorders in 112 Patients, Classification of Complications in 64 patients. While the majority of claims are found to lack merit, resulting in a verdict in favor of the defendant or case dismissal,7,1316 at least 37% are considered valid.26 Regardless, payouts to plaintiffs are often substantial, averaging in the hundreds of thousands to millions of dollars in both the US and Europe.10,11,14,17,20 Communication of errors and expectations, thorough documentation, and selection of appropriate patients and surgical indications have been shown to reduce the likelihood of a successful malpractice claim.13,16,27,28 In addition, attempts at tort reform in some states have helped limit the financial burden of medical malpractice payouts through methods such as capitation.16,20,22,26 However, efforts to limit malpractice claims in the first place are greatly needed. Spine Deform. 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 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. Neurosurgery. Mohar J, Vali M, Podovovnik E, Mihali R. Eur Spine J. 18. Litigation resulted in average payouts of $1,204,422 $753,832 between 1995 and 2019, when adjusted for inflation. Among the plaintiff-awarded cases, 13 (61.9%) were decided by jury trial, 7 (33.3%) by settlement, and 1 (4.8%) by arbitration. J Bone Joint Surg 45A:11591170, 1963. The site is secure. 2 One of the first obstacles regarding . Nayar G, Blizzard DJ, Wang TY, et al. This patient recovered completely in 6 weeks. 2016;102(2):358362. 2019;19(7):12211231. Under the high-low agreement, Drs. A total of 47 (69.1%) cases resulted in a decision for the defendant and 21 (30.9%) for the plaintiff. There were no observed cases of screw misplacement outside the pedicle on routine AP and lateral radiographs. 2009;10(1):3339. 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. 2012;41(2):6973. 16,24,28 Simultaneously, the evolution of the surgical techniques has led to increased procedural safety. Phone/Fax: 30-2810-318361; E-mail: [emailprotected]. Copyright 1944-2023 American Association of Neurological Surgeons, Copy this link, or click below to email it to a friend. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 13. 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. Results: A total of 2724 screws were placed in 127 patients. Studdert DM, Mello MM, Sage WM, et al. However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. 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. However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. 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. When adjusted for inflation, these values increased to $1,330,201 $882,023 versus $970,832 $381,619, respectively (p = 0.32; Fig. Dalenberg DD, Asher MA, Robinson RG, Jayaraman G: The effect of a stiff spinal implant and its loosening on bone mineral content in canines. However, the misplacement of pedicle screws can lead to disastrous complications because of the close proximity to neural tissue and the surrounding vessels, although rare, serious complications have been reported, such as dural tear, nerve-root irritation, neural injury . Spine (Phila Pa 1976). Roy-Camille R, Saillant G, Mazel C: Internal fixation of the lumbar spine with pedicle screw plating. 2002;27(22):24252430. reported that 69.3% of neurosurgeons who responded to their survey saw every patient as a potential lawsuit.1. 1 To be effective, the pedicle screw constructs must withstand intraoperative loading and physiological forces due to daily postoperative activities. Clipboard, Search History, and several other advanced features are temporarily unavailable. Dr. Goodwin has received grants from the Burroughs Wellcome Fund, North Carolina Spine Society, and Robert Wood Johnson Harold Amos Medical Faculty Development Program and the NIH/NINDS K12 NRCDP Physician Scientist Award. Pedicle screws are used by spine surgeons as part of a fusion in which two adjacent bones in the spine are combined together as one. A total of 69 patients (mean age, 67.416 . Seabury SA, Chandra A, Lakdawalla DN, Jena AB. Erwin WD, Dickson JH, Harrington PR: Clinical review of patients with broken Harrington rods. Rothberg MB, Class J, Bishop TF, et al. To prevent the development of pseudarthrosis, we think it is important for surgeons to apply the following five technical principles: the proper-sized pedicle screw has to be inserted on the first attempt; repeated manipulation in setting instruments must be avoided; anterior penetration of the screw into the sacrum and insertion of two screws in each side are advocated for fixing the lumbosacral junction; industrious and detailed decortication of the posterior elements must be developed fully; and the use of autologous bone graft is recommended. 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. With increasing pedicle screw usage, the number of patients with misplaced screws will likely increase proportionally. The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. A.J. Submitting a contact form, sending a text message, making a phone call, or leaving a voicemail does not create an attorney-client relationship. Per-patient analysis reveals more concerning numbers toward screw misplacement. The initial search using the terms above returned 3654 cases. 2018;41(5):e615e620. J Neurosurg. Katonis, Pavlos MD*; Christoforakis, Joseph MD*; Aligizakis, Agisilaos C. MD*; Papadopoulos, Charalampos MD*; Sapkas, George MD, DSc**; Hadjipavlou, Alexander MD*. Retrospective analysis of reasons and revision strategy for failed thoracolumbar fracture surgery by posterior approach: a series of 31 cases. 2012;21(suppl 2):S196S199. Rev Chir Orthop Reparatrice Appar Mot 62:151160, 1976. 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. 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. 7. Spine 16:576579, 1991. 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. At the trials close, the plaintiffs attorney had asked the jury to return a $5.3 million verdict and had made a prior demand to settle the medical malpractice lawsuit for $1 million. The accuracy rate of pedicle screw (PS) placement varies from 85% to 95% in the literature. Spine 8:970981, 1996. In White AH, Rothman RH, Ray CD (eds). The standard imaging technique for pedicle screw insertion is two-dimensional images obtained from C-arm-type X-ray fluoroscopy. Laryngoscope. The physician ordered an MRI of the lumbar spine which showed that the screws had been misplaced and were puncturing the patient's lumbar nerves. Ann Thorac Surg. Arthrodesis was questionable in eight asymptomatic patients (7.1%). Examples of both laterally and medially misplaced lumbar pedicle screws are provided in Fig. The development of the transpedicle screw has provided control of the vertebral motion segment in each plane, resisting any type of load. Melissa Nyquist required a lumbar back fusion for a herniated disc at the L4-5 level. 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. All the incidental dural tears were repaired immediately and produced no clinical sequelae. 6. 5. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. Debate Over Extent of Eye Damage Following Implant Lens Surgery Leads to $1 Million Verdict in Zaleski v Elmhurst Eye Surgery Center. Spine (Phila Pa 1976). Yuan HA, Garfin SR, Dickman CA, Mardjetko SM: A historical cohort study of pedicle screw fixation in thoracic, lumbar and sacral spinal fusions. Patient safety: disclosure of medical errors and risk mitigation. None of these complications resulted in additional surgery or in a significant increase of morbidity. leg pain. 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 Malpractice claims in spine surgery in Germany: a 5-year analysis. The states with the most cases included California (n = 10, 14.7%), New York (n = 6, 8.8%), Pennsylvania (n = 6, 8.8%), and Illinois (n = 5, 7.3%; Table 2). 3). Defendant-awarded cases by US region (right). Dr. Abd-El-Barr is a consultant for Spineology. Please enable it to take advantage of the complete set of features! 2013;32(1):111119. 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. 2007;106(6):11081114. Ultimately, no significant differences were seen in inflation-adjusted award information between plaintiff and defendant (Table 3). 15. 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. 38. Nahed BV, Babu MA, Smith TR, Heary RF. Privacy Policy. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). Am J Orthop. Defensive medicine: a culprit in spiking healthcare costs. J Neurosurg Spine. Mayo Clinic uses the latest robot-assisted technology when indicated to enhance surgical precision in these procedures. 2. 3. Clinical Orthopaedics and Related Research411:86-94, June 2003. pedicle screw: A rigid surgical implant used to stabilize adjacent spinal segments in spinal fusion surgery. Likewise, research shows that breaches still occur when these tools are used,33,40 and some studies did not find a difference in pedicle breach rates compared to those with traditional fluoroscopic and freehand techniques.33 Ultimately, misplaced instrumentation is a risk of any spinal fusion surgery, and a thorough discussion of these risks, as well as the alternative management options, is essential to maintain high-quality patient care and to avoid litigation. Saillant G: Etude anatomique des pedicules vertebraux: Application chirurgicale. Materials and Methods Sixty . Br J Neurosurg. You may be trying to access this site from a secured browser on the server. Intraoperative pedicle fractures requiring further points of fixation. Neurosurgery. Epub 2022 Oct 29. 30. 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. 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. 3. 4). Mean amounts awarded SD to plaintiffs by jury trial (n = 13) versus settlement/arbitration (n = 7), adjusted for inflation as of April 2020. A rod is used to hold the vertebra together to allow fusion to occur. Whitecloud III TS, Butler JC, Cohen JL, Candelora PD: Complications with the variable spinal plating system. 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). 32. J Am Coll Surg. Per-patient analysis showed 23 (18.11%) of patients had all screws AP. Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. Eur Spine J. 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). Spine J. 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. Finally, considering the problems of balance, it seems that failure to properly evaluate any preexisting scoliosis was a main cause of this important complication. Guillain A, Moncany AH, Hamel O, et al. Brodsky AE: Post-laminectomy and post-fusion stenosis of the lumbar spine. Steinmann JC, Herkowitz HN: Pseudarthrosis of the spine. Acquisition of data: Sankey. Each side was judged separately. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. 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. 28. Feb. 16, 2021 Accurate placement of pedicle screws is key to avoiding the potential complications of spinal fusion surgery and improving overall spinal fixation. J Spine Surg. The majority of plaintiffs were male (n = 44, 64.7%), and the median age among all cases was 46 years (range 3757 years). 2018;27(9):23392347. 29. Lumbar Spine Surgery. Instrumentation removal is an option for patients with successful arthrodesis, but remains controversial.