pedicle screw misplacement malpractice

1 Although this technique has advantages over open instrumentation, it also presents new challenges and specific complications. Privacy Policy. Administrative/technical/material support: Mehta, Wang, KD Than. Facebook Google Plus Youtube RSS Email. Materials and Methods Sixty . One of the patients had a late wound infection develop that was treated by radical debridement and removal of instrumentation. Author links open overlay panel Mohamad Bydon a b 1, Dimitrios Mathios a b 1, Mohamed Macki a b, Rafael De la Garza-Ramos a b, Nafi Aygun c, Daniel M. Sciubba a, Timothy F. Witham a, Ziya L. Gokaslan a b, Ali Bydon a b, Jean-Paul Wolinksy a. Spine 15:1114, 1990. 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. 29. Review of neurosurgery medical professional liability claims in the United States. 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. laterally placed screws and the azygous vein on the right (T5-T11). In 2 patients, misplacement of pedicle screws was recognized intraoperatively and all implants were removed. 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. 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). The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 144 A neurologic deficit developed in one patient (0.9%) who had partial bilateral drop feet after reduction of L4L5 spondylolisthesis. It should be used by experienced and qualified surgeons who are aware of the pitfalls associated with its use. Spine 13:10121018, 1988. 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. 3. All the incidental dural tears were repaired immediately and produced no clinical sequelae. Spine 13:952953, 1988. $ = US$; MW = Midwest; NE = Northeast; SE = Southeast; SW = Southwest; W = West. 15. 2022 Dec;31(12):3544-3550. doi: 10.1007/s00586-022-07427-0. 2012 Feb 1;37(3):E188-94. Luque ER: Segmental spinal instrumentation of lumbar spine. Lumbar Spine Surgery. Instead, the defense offered up an alternative explanation for Nyquists foot drop. However, the misplacement of pedicle screws can lead to disastrous complications. J Bone Joint Surg 62A:13021307, 1980. There were 74 men and 38 women, with a mean age of 47 years (range, 1872 years). 4. Two patients had an acute infection develop for which they required operative intervention with irrigation and debridement. 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. Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. 2014;20(2):196203. All of these patients were asymptomatic and had satisfactory final clinical outcomes (Fig 2). Another possible cause was the high lateral torques to the entire frame that occurred during tightening of the tulip screw. These numbers are in line with the current literature. 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. Therefore, when instrumentation is to be used, the benefits must outweigh the risks. Accessibility The largest inflation-adjusted payout awarded to the plaintiff ($3,372,185) for nerve root injury occurred in a 36-year-old male who had undergone an L4S1 posterior spinal fusion, which resulted in permanent and direct injury to right L5 and S1 nerve roots, with foot drop and radiculopathy. Please try after some time. 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. In their meta-analysis of nine randomized controlled trials, Li et al. Spine 18:23252326, 1993. 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. Defensive medicine: a culprit in spiking healthcare costs. Each case was then carefully screened for relevance and sufficient data. 19. However, this is the first study to evaluate the direct medicolegal impact of misplaced pedicle and lateral mass screws on spine surgery in the US and presents important information that may support the routine use of intraoperative imaging confirmation (via 3D fluoroscopy or intraoperative CT) and/or navigated screw placement (either computer- or robot-assisted) as a potential method to decrease the risk of future litigation during spinal fusion procedures. Gertzbein SD, Robbins SE: Accuracy of pedicular screw placement in vivo. 2014;20(6):636643. Erwin WD, Dickson JH, Harrington PR: Clinical review of patients with broken Harrington rods. shooting in valdosta leaves one dead Critically revising the article: all authors. On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. Pedicle screw instrumentation is widely used for the stabilization of the subaxial cervical, thoracic, and lumbar spine. Thus, meaningful efforts to limit the rate of misplaced pedicle and lateral mass screws, such as the routine use of intraoperative imaging confirmation and/or computer- or robot-assisted navigation, should be carefully considered. Spine J. In the other patient, L4L5 float arthrodesis was done. The rate of reoperation for screw misplacement per screw was 0.17%. Spine 16(8 Suppl):S422427, 1991. Roy-Camille R, Saillant G, Mazel C: Internal fixation of the lumbar spine with pedicle screw plating. 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. 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). All Rights Reserved. [] Computer-assisted computed tomography (CT) techniques have improved the overall accuracy for pedicle screw placement, and has reduced complication rates. 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. 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. 2012;89(10):7071. 2002;27(22):24252430. A retrospective review of charts, x-rays (XRs) and computed tomography (CT) scans was performed. Problems of balance were coronal (scoliosis greater than 5 or trunk shift greater than 5 mm) as seen on the AP radiograph taken with the patient standing or sagittal (failure to obtain or maintain lumbar lordosis). The last two patients had a T12L1 fracture-dislocation and a L4L5 spondylolytic spondylolisthesis at the site of plug dislodgments. 2021 Jul 1;41(Suppl 1):S80-S86. Harrington PR, Tullos HS: Reduction of severe spondylolisthesis in children. Epub 2014 Jun 13. 2011;213(5):657667. 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. Notwithstanding these concessions, the MDU argued that misplacement of pedicle screw tracts was common in surgery of this kind, even in experienced and competent hands. The third patient, who had central spinal stenosis, was treated by decompression alone. It has a great developing technique that is used for fixation and fusion in spine surgery. This study quantifies the rate of screw misplacement on a per-patient basis to highlight its effect on potential morbidity. Forty-seven intraoperative and medical complications were observed in 41 patients (36.6%). Zdeblick TA: A prospective randomized study of lumbar fusion: Preliminary results. The https:// ensures that you are connecting to the Krag MH, Beynnon BD, Pope MH, et al: An internal fixator for posterior application to short segment of the thoracic, lumbar, or lumbosacral spine. J Pediatr Orthop. Mean amounts awarded SD to plaintiffs by jury trial (n = 13) versus settlement/arbitration (n = 7), adjusted for inflation as of April 2020. Submitting a contact form, sending a text message, making a phone call, or leaving a voicemail does not create an attorney-client relationship. 39. 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. The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. Spine 14:472476, 1989. To prevent general complications, it is evident that precise and careful soft tissue handling, proper irrigation, and debridement during and after surgery, decrease of operative time, and proper patient monitoring postoperatively must be done. J Neurosurg Spine. Aigner R, Bichlmaier C, Oberkircher L, Knauf T, Knig A, Lechler P, Ruchholtz S, Frink M. BMC Musculoskelet Disord. 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 instrumentation in the thoracolumbar and lumbar spine is a technically challenging procedure. Copyright 1944-2023 American Association of Neurological Surgeons, Copy this link, or click below to email it to a friend. Two patients had early postoperative postural headache that disappeared after removal of the misplaced screw. A p < 0.05 was considered statistically significant. Clin Orthop 227:1023, 1988. Results. Malpractice litigation following spine surgery. Before All these problems were observed only just above the upper instrumentation level and all were observed in patients older than 55 years. Quraishi NA, Hammett TC, Todd DB, et al. 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. Please enable it to take advantage of the complete set of features! 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. Of the 112 patients, 57 patients had a lumbar degenerative disorder, (lumbar degenerative spinal canal stenosis in 23 patients, degenerative or spondylolytic spondylolisthesis in 12 patients, postlaminectomy instability or stenosis in 20 patients, and recurrent disc prolapse in two patients), 42 patients had spinal cord injury, eight patients had infection, and five patients had a spinal tumor (Table 1). Bethesda, MD 20894, Web Policies 6. 2017;27(4):470475. Forty-seven general complications were seen in 41 patients (36.5%). Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Ann Thorac Surg. 3. 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. NCI CPTC Antibody Characterization Program. The development of the transpedicle screw has provided control of the vertebral motion segment in each plane, resisting any type of load. JAMA. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. 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. There were nine instrumentation failures at the thoracolumbar area (seven patients), lumbar area (one patient), and lumbosacral area (one patient). A Cotrel-Dubousset spinal system (Medtronic Sofamor Danek, Memphis, TN) was used in all patients and the total number of screws used was 658. ObjectThe goal of this study was to determine the incidence of screw misplacement and complications in a group of 102 patients who underwent transpedicle screw fixation in the lumbosacral spine with conventional open technique and intraoperative. Sarwahi V, Ayan S, Amaral T, Wendolowski S, Gecelter R, Lo Y, Thornhill B. Spine Deform. Spine 18:18621866, 1993. to maintaining your privacy and will not share your personal information without 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. Cerebrospinal fluid fistulas. 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. Unfortunately, the plaintiffs attorney was unable to offer an alternative theory of surgical negligence that would refute the defendants explanation. 2012;21(suppl 2):S196S199. In order to prove medical malpractice occurred, the plaintiffs attorney needs to show not only the plaintiff experienced a poor medical outcome, but that it was directly caused by medical negligence. Problems in the instrumented segments were considered those occurring from narrowing of the disc space greater than 3 mm, pseudarthrosis, and loss of reduction. 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. All Rights Reserved. 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. Wolters Kluwer Health Int Orthop 20:3542, 1996. Spine arthrodesis was evaluated with plain AP and lateral radiographs taken 1 year after surgery. Clin Orthop 203:126134, 1986. Nahed BV, Babu MA, Smith TR, Heary RF. 34. 12. Call me tomorrow. N Engl J Med. Koktekir E, Ceylan D, Tatarli N, Karabagli H, Recber F, Akdemir G. Spine J. Ultimately, no significant differences in case demographics were found between plaintiff and defendant judgments (Table 1). 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. 25. J Bone Joint Surg 45A:11591170, 1963. 2011;24(1):1519. The instrumentation and bone graft were left in place in these patients (total infection rate, 2.7%). However, the impact of robotic-assisted spinal fusion on patient outcomes is less clear. Rovit RL, Simon AS, Drew J, et al. Error in trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. Neurologic injury. The cost of defensive medicine on 3 hospital medicine services, Defensive medicine in neurosurgery: the Canadian experience, Review of neurosurgery medical professional liability claims in the United States, A nine-year review of medicolegal claims in neurosurgery, Malpractice risk according to physician specialty, Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003, Descriptive analysis of state and federal spine surgery malpractice litigation in the United States, Malpractice litigation following spine surgery, Medical malpractice in orthopedic surgery: a Westlaw-based demographic analysis, Malpractice claims in spine surgery in Germany: a 5-year analysis, On average, physicians spend nearly 11 percent of their 40-year careers with an open, unresolved malpractice claim, Malpractice litigation and the spine: the NHS perspective on 235 successful claims in England, Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort, It is easier to confuse a jury than convince a judge: the crisis in medical malpractice, Determining legal responsibility in otolaryngology: a review of 44 trials since 2008, Legal liability in iatrogenic orbital injury, Spine neurosurgeons facing the judicialization of their profession: disenchantment and alteration of daily practicea qualitative study, Malpractice issues in neurological surgery. Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. 2020;11:38. 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. Some error has occurred while processing your request. 1,12,19,22 The largest series of adjacent segment breakdown was reported by Schlegel et al. 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. Seabury SA, Chandra A, Lakdawalla DN, Jena AB. Level of evidence: 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. Conclusion: A TLIF is a surgical procedure that attempts to fuse vertebrae in order to stabilize the patient's spine. 2020;45(2):E111E119. Clin Orthop 115:130139, 1976. Rev Chir Orthop Reparatrice Appar Mot 62:151160, 1976. 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. pedicle screw: A rigid surgical implant used to stabilize adjacent spinal segments in spinal fusion surgery. The rod is held in place by "pedicle screws," which the surgeon must insert into the pedicles. Drs. The site is secure. Spinal fusion in the United States: analysis of trends from 1998 to 2008. 37. your express consent. 20. These complications may have resulted from powerful bending movement acting on the screw at its entry point to the bone. 35. Makhni MC, Park PJ, Jimenez J, et al. Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. 8. Neurosurgery. Similar to our findings, prior studies have shown that settlements result in lower payouts than cases that are ultimately taken to trial,7,14,15,30 with awards ranging from $125,000 to $9,000,000 compared to $134,000 to more than $38,000,000.7,15 Nevertheless, the true financial toll on spine surgery is largely unknown given that 85% of cases are dismissed or settled out of court, with undisclosed amounts.14 Likewise, substantial time is spent and costs, including legal and administrative, are incurred before judgment, as noted above. Screws penetrating the anterior cortex and abutting vascular structures, particularly aortic abutment with left-sided screws, which can lead to erosion and pseudoaneurysms. Spine (Phila Pa 1976). 2014;21(3):320328. Debate Over Extent of Eye Damage Following Implant Lens Surgery Leads to $1 Million Verdict in Zaleski v Elmhurst Eye Surgery Center. [] The accuracy for free-hand screw placement technique varies from 69% to 94%. Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. 1. Wiltse LL, Spencer CW: New uses and refinements of the paraspinal approach to the lumbar spine. The patient had to undergo a subsequent surgery to remove the pedicles. Todd NV. A total of 2396 screws were placed accurately (87.96%). In addition, the median time to judgment is substantial, particularly for defendant verdicts, spanning over 4.5 years from the time of surgery. 31. Using chi square analysis, statistically significant correlation was seen between disc space narrowing and loss of postoperative correction (p < 0.01). None of these complications resulted in additional surgery or in a significant increase of morbidity. However, the defendant doctor maintained that Nyquists foot drop was not caused by the misplaced screw. 8600 Rockville Pike The majority of plaintiffs were male (n = 44, 64.7%), and the median age among all cases was 46 years (range 3757 years). 2011;365(7):629636. Pedicle screw placement is a common procedure. Spine 16(8 Suppl):S455458, 1991. The screws were needed to stabilize the spine and fix the fused vertebrae in place. In unstable injuries, the segments above and below the level of injury may have a different orientation of the pedicle trajectory due to . The amount awarded was not significantly different across US regions (p = 0.9; Fig. The aim of this study is to evaluate the accuracy of pedicle screw insertion in spondylitis tuberculosis kyphosis correction using a freehand technique. Personal consequences of malpractice lawsuits on American surgeons. Moffatt-Bruce SD, Ferdinand FD, Fann JI. Results: 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. Per-patient analysis reveals more concerning numbers toward screw misplacement. 2. 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. 13. The link was not copied. The patient had subsequent coronal imbalance and degeneration of the upper disc. In addition, seven (6.3%) dural tears occurred during the decompression and none occurred during instrumentation. Pitfall: Unstable injuries. The medicolegal landscape of spine surgery: how do surgeons fare? Clipboard, Search History, and several other advanced features are temporarily unavailable. 2014;174(11):18671868. Louw JA, Dommissee GF, Roos MF: Spinal stenosis following anterior spinal fusion. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. In patients with degenerative conditions, all of the affected segments were included in the instrumentation and each vertebra was fixed with two pedicle screws. Reprint requests to Pavlos Katonis, MD, 99 Minoos & Thenon Street, 71305, Heraklion, Crete, Greece. Please enable scripts and reload this page. 8,24,25,32. Smith TR, Hulou MM, Yan SC, et al. Svider PF, Husain Q, Kovalerchik O, et al. Acquisition of data: Sankey. 3,4,9,29,34 In addition, developments in surgical technique and implant design have decreased operative risk and implant-related complications. Summary of background data: * One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. 2018;83(5):9971006. Analysis and interpretation of data: Sankey, TT Than. West III JL, Bradford DS, Ogilvie JW: Complications of the variable screw pedicle screw fixation. Potential complications may include increased pain, infection, or mechanical . 36. Rajasekaran S, Bhushan M, Aiyer S, et al. sharing sensitive information, make sure youre on a federal They both had motor deficits from which 1 patient recovered completely. Dr. Abd-El-Barr is a consultant for Spineology. 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. Rynecki ND, Coban D, Gantz O, et al. 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 .