pedicle screw misplacement malpractice pedicle screw misplacement malpractice

Dr. Shaffrey has received grants from the NIH and Department of Defense. Sethi MK, Obremskey WT, Natividad H, et al. Disclosures Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. 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. Malpractice issues in neurological surgery. 36. The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement. 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. Clin Orthop 203:4553, 1986. Results: Daniels AH, Ruttiman R, Eltorai AEM, et al. Clin Orthop 284:8090, 1992. Epstein NE. Steinmann JC, Herkowitz HN: Pseudarthrosis of the spine. Pedicle screw construct have become one of the most practiced procedure in spinal surgery. 1. Eur Spine J. Schatlo B, Molliqaj G, Cuvinciuc V, et al. Spine 13:10121018, 1988. The aim of this study is to evaluate the accuracy of pedicle screw insertion in spondylitis tuberculosis kyphosis correction using a freehand technique. 16,24,28 Simultaneously, the evolution of the surgical techniques has led to increased procedural safety. 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. In addition, the median time to judgment is substantial, particularly for defendant verdicts, spanning over 4.5 years from the time of surgery. 2021 Nov;9(6):1541-1548. doi: 10.1007/s43390-021-00377-5. 20. J Neurosurg Spine. and transmitted securely. Spine 17:349355, 1992. Epub 2014 Jun 13. It should be used by experienced and qualified surgeons who are aware of the pitfalls associated with its use. St Louis, CV Mosby 322327, 1987. These numbers are in line with the current literature. Breakage of a divergent screw of a Chopin block at the lumbosacral area was seen 3 months after surgery. Makhni MC, Park PJ, Jimenez J, et al. + 48 696 042 504. Spine 18:11601172, 1993. In the current study, only five patients with junction problems above the instrumented area were observed with the following probable predisposing factors: an already degenerative disc, coronal imbalance, very long arthrodesis, and old age. Luque ER: Segmental spinal instrumentation of lumbar spine. 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. Median screw misplacement rate was 10% in group A and 13% in group B. 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. Fortunately, most of the complications were minor and transient. 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. The rod is held in place by "pedicle screws," which the surgeon must insert into the pedicles. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. However, the medicolegal impact of misplaced screws on spine surgery has not been directly reported in the literature. 3. 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. Spine 15:1114, 1990. Incidence and costs of defensive medicine among orthopedic surgeons in the United States: a national survey study. Roy-Camille R, Saillant G, Mazel C: Internal fixation of the lumbar spine with pedicle screw plating. JAMA. 2. 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. Malpractice litigation and the spine: the NHS perspective on 235 successful claims in England. Another possible cause was the high lateral torques to the entire frame that occurred during tightening of the tulip screw. Spine 18:18621866, 1993. Hsu K, Zucherman JF, White AH: Internal Fixation With Pedicle Screws. Your message has been successfully sent to your colleague. Spine 17:834837, 1992. However, the misplacement of pedicle screws can lead to disastrous complications. What can spine surgeons do to improve patient care and avoid medical negligence suits? Lumbar Spine Surgery. 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. 2014;20(2):196203. The accuracy rate of pedicle screw (PS) placement varies from 85% to 95% in the literature. Federal government websites often end in .gov or .mil. In addition, seven (6.3%) dural tears occurred during the decompression and none occurred during instrumentation. You are talking one of the most complicated area of the law. Analysis and interpretation of data: Sankey, TT Than. Importantly, these advanced technologies are not always readily available or the standard of care and cannot supplant a thorough understanding of operative anatomy, a high-quality surgical technique, and general complication-avoidance measures. 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. Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. 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. In situ spine arthrodesis permits load sharing by the vertebral bodies, preventing fatigue failure of the implant. 2011;213(5):657667. The accuracy of pedicle screw placement using intraoperative image guidance systems. 5. 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). This patient recovered completely in 6 weeks. 2014 Sep;21(3):320-8. doi: 10.3171/2014.5.SPINE13567. Spine (Phila Pa 1976). INCLUDE WHEN CITING DOI: 10.3171/2020.8.FOCUS20600. The pedicle screw system is widely used in spine surgery, and it provides rigid fixation and leads to successful subsequent deformity correction and bony fusion. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. Spine 19(20 Suppl):2279S2296, 1994. Moffatt-Bruce SD, Ferdinand FD, Fann JI. On average, physicians spend nearly 11 percent of their 40-year careers with an open, unresolved malpractice claim. shooting in valdosta leaves one dead Morphometric analysis of the proximal thoracic pedicles in Lenke II and IV adolescent idiopathic scoliosis: an evaluation of the feasibility for pedicle screw insertion. Dr. Abd-El-Barr is a consultant for Spineology. 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? Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. Over 40% of patients had screws with either some/major concern. Pedicle screw insertion in the thoracolumbar spine. However, the highest offer had been a combined $300,000 from the two defendants. Would you like email updates of new search results? 14. The instrumentation and bone graft were left in place in these patients (total infection rate, 2.7%). Katonis, Pavlos MD*; Christoforakis, Joseph MD*; Aligizakis, Agisilaos C. MD*; Papadopoulos, Charalampos MD*; Sapkas, George MD, DSc**; Hadjipavlou, Alexander MD*. Svider PF, Husain Q, Kovalerchik O, et al. 23. Nayar G, Blizzard DJ, Wang TY, et al. 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. Descriptive analysis of state and federal spine surgery malpractice litigation in the United States. Characteristics of medicolegal cases related to misplaced screws in spine surgery. Level of evidence: Thirty-five (27.56%) had IMP and 18 (14.17%) had SAR. (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. Schlegel JD, Smith JA, Schleusener RN: Lumbar motion segment pathology adjacent to thoracolumbar, lumbar, and lumbosacral fusions. 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. The site is secure. 31. Hardware problems were those related to the physical change of metal and screw position. 4. These risks can be minimized by the judicious use of instrumentation by experienced surgeons for specific indications as supported by the literature. There were two complete degenerations of the upper disc, one central canal stenosis, and two asymptomatic disc space narrowings and retrolistheses. Sarwahi V, Ayan S, Amaral T, Wendolowski S, Gecelter R, Lo Y, Thornhill B. Spine Deform. J Bone Joint Surg 61A:201207, 1979. Ultimately, no significant differences were seen in inflation-adjusted award information between plaintiff and defendant (Table 3). Am J Transl Res. 1. One hundred four of the 112 patients had a posterior procedure. 21. Elsamadicy AA, Sergesketter AR, Frakes MD, Lad SP. 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. Long spine fixation was necessary for patients with tuberculous spondylitis and metastatic disease. Copyright © 2023 Becker's Healthcare. 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. 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. Grubb SA, Lipscomb HJ: Results of lumbosacral fusion for degenerative disc disease with and without instrumentation: Two- to five-year follow-up. J Bone Joint Surg 62A:13021307, 1980. Rajasekaran S, Bhushan M, Aiyer S, et al. Show more. 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. Please enable it to take advantage of the complete set of features! Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. Steffee AD, Brantigan JW: The variable screw placement spinal fixation system: Report of a prospective study of 250 patients enrolled in Food and Drug Administration clinical trials. The contact form sends information by non-encrypted email, which is not secure. 2021 Jul 1;41(Suppl 1):S80-S86. Careers. 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. 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. 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. Of note, the award amount for one settlement case was undisclosed. Surg Neurol Int. This was followed by pseudarthrosis requiring revision surgery, present in 14.3% (n = 3) and 14.9% (n = 7) of plaintiff- and defendant-awarded cases, respectively (p = 0.99). Segal J. Balch CM, Oreskovich MR, Dyrbye LN, et al. 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. 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. Before Some error has occurred while processing your request. All Rights Reserved. laterally placed screws and the azygous vein on the right (T5-T11). 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. It was firstly introduced by Harrington and Tullos in 1969 and then in late 1980s developed by Roy Camille et al., Louis, and Steffe. Deyo RA, Mirza SK, Martin BI. Administrative/technical/material support: Mehta, Wang, KD Than. A.J. There were nine instrumentation failures at the thoracolumbar area (seven patients), lumbar area (one patient), and lumbosacral area (one patient). A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? 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. Amount awarded to plaintiffs by US region, adjusted for inflation as of April 2020. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Studies have shown that the greatest proportion of malpractice claims in spine surgery are related to procedural error,10,11,14,16,17,19 often resulting in the highest payouts.11,20 For spine surgery, one common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass screws, which occurs in approximately 14%55% of cases using standard techniques and results in neurological injury and/or durotomy in approximately 1%8% of cases.21 Misplaced screws have the potential to cause severe and sometimes permanent neurological deficits, including spinal cord and/or nerve root injury,21 as well as to decrease the stability of the fusion construct, leading to delayed complications related to pseudarthrosis. 11. 2009;10(1):3339. 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. 2 One of the first obstacles regarding . Mason A, Paulsen R, Babuska JM, et al. 16. 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. In the Kane County medical malpractice lawsuit of Melissa Nyquist v. Dr. Taras Masnyk and DuPage Neurosurgery, S.C., 06 L 421, the plaintiffs attorney was unable to convince the jury that the plaintiffs medical complications were caused by the defendants negligence. concluded that the robot-assisted technique was significantly more accurate than the traditional freehand technique.39 Despite the learning curve and initial cost of obtaining technologies such as 3D fluoroscopic devices, intraoperative CT, or robotic navigational systems, the routine use of these technologies for intraoperative imaging confirmation and potential revision of misplaced screws may help spine surgeons avoid inadvertent iatrogenic morbidity for their patients and potential litigation. Surg Neurol. 2. Spine J. Placement of the pedicle screws in the thoracolumbar and lumbar spine is a technically demanding procedure. Larson AN, Santos ER, Polly DW Jr, Ledonio CG, Sembrano JN, Mielke CH, Guidera KJ. 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 average followup was 35 months (range, 1851 months). Accuracy of C2 pedicle screw placement using the anatomic freehand technique. Insuring spinal neurosurgery. Int Orthop 20:3542, 1996. Please do not include any confidential or sensitive information in a contact form, text message, or voicemail. 1. Ultimately, no significant differences in case demographics were found between plaintiff and defendant judgments (Table 1). 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. Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. Presse Med 78:14471448, 1970. Cerebrospinal fluid fistulas. 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. Conclusion: FOIA J Neurosurg Spine. Per-patient analysis showed 23 (18.11%) of patients had all screws AP. 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. Pedicle screw placement is a common procedure. Todd NV. National Library of Medicine 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. Bookshelf Spine 14:472476, 1989. 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). Thu, May 27th, 2021. 1,12,19,22 The largest series of adjacent segment breakdown was reported by Schlegel et al. Problems in the instrumented segments were considered those occurring from narrowing of the disc space greater than 3 mm, pseudarthrosis, and loss of reduction. 3. Brodsky AE: Post-laminectomy and post-fusion stenosis of the lumbar spine. Moreover, local court rulings are not included in the Westlaw Edge database; however, this is unlikely to present meaningful bias given that malpractice claims are generally filed in state courts. Intraoperative and postoperative complications were recorded by the authors and the results were evaluated by an independent observer. The .gov means its official. 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. We avoid using sharp automated drilling, and probe fully the pedicle cavity to prevent nerve root impairment. reported that 69.3% of neurosurgeons who responded to their survey saw every patient as a potential lawsuit.1. Clipboard, Search History, and several other advanced features are temporarily unavailable. PLoS One. Inaccurate pedicle screw placement is relatively common even when placement is performed under fluoroscopic control. 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. 2006;65(4):416421. 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. were excluded from analysis. Finally, considering the problems of balance, it seems that failure to properly evaluate any preexisting scoliosis was a main cause of this important complication. Neurologic injury. $ = US$; MW = Midwest; NE = Northeast; SE = Southeast; SW = Southwest; W = West. You may be trying to access this site from a secured browser on the server. Better strategies need to be devised for evaluation of screw placement, including establishment of a national database of deformity surgery, use of intra-operative image guidance, and reevaluation of postoperative low-dose CT imaging. 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. 15. J Pediatr Orthop. In patients with degenerative conditions, all of the affected segments were included in the instrumentation and each vertebra was fixed with two pedicle screws. Once the spine is exposed, the appropriate levels of fixation are confirmed with the image intensifier. Ahmadi SA, Sadat H, Scheufler KM, et al. 8600 Rockville Pike 4. J Spinal Disord Tech. 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). 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. Therefore, when instrumentation is to be used, the benefits must outweigh the risks. Smith TR, Hulou MM, Yan SC, et al. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? 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).