0 attorneys agreed. Ultimately, no significant differences were seen in inflation-adjusted award information between plaintiff and defendant (Table 3). They both had motor deficits from which 1 patient recovered completely. 2016;124(5):15241530. 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. 2018;29(4):397406. Roy-Camille R, Roy-Camille M, Demeulenaere C: Osteosynthese du rachis dorsal, lombaire et lombo-sacre par plaque metalliques vissees dans les pedicules vertebraux et es apophyses articularies. 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. and transmitted securely. Pitfall: Unstable injuries. Routine CT scans were taken in all patients. Spine 16(8 Suppl):S422427, 1991. haroinfather roblox id Laryngoscope. Surg Neurol Int. States were then grouped by US region and case year by 5-year intervals. In six of these patients with injuries at the thoracolumbar area (four patients with bent screws and two patients with broken screws), the loss of correction ranged from 3 to 4.5 without change of anatomic reduction (Fig 1). 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. 8600 Rockville Pike Amount awarded to plaintiffs by US region, adjusted for inflation as of April 2020. 23. Spine 18:11601172, 1993. Results: Introduction. 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. 2013;34(6):699705. In two patients in the current series, dislodgement of the rods from tulip screws occurred, as reported originally by Edmunds et al. Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. Spine (Phila Pa 1976). 2014;21(3):320328. 32. 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. 29. 1 Although this technique has advantages over open instrumentation, it also presents new challenges and specific complications. Edwards CC: Spinal screw fixation of the lumbar and sacral spine: Early results treating the first 50 cases. Svider PF, Husain Q, Kovalerchik O, et al. Spine 19:25842589, 1994. Facebook Google Plus Youtube RSS Email. Please try again soon. single homes for sale in lehigh valley, pa St Louis, CV Mosby 322327, 1987. Comparetto, Esq., 727-328-7900, www.florida-malpractice-lawyers.com. 2014;20(2):196203. 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 six patients (5.3%) with degenerative spine disease, the disc material had been removed. Placement of the pedicle screws in the thoracolumbar and lumbar spine is a technically demanding procedure. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. Results: A total of 2724 screws were placed in 127 patients. Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison. Grubb SA, Lipscomb HJ: Results of lumbosacral fusion for degenerative disc disease with and without instrumentation: Two- to five-year follow-up. (PDF) Lumbosacral pedicle screw placement using a fluoroscopic pedicle J Bone Joint Surg 45A:11591170, 1963. Examples of both laterally and medially misplaced lumbar pedicle screws are provided in Fig. 33. Spine (Phila Pa 1976). However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. The rate of reoperation for screw misplacement per screw was 0.17%. 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. 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). In 2 patients, misplacement of pedicle screws was recognized intraoperatively and all implants were removed. Linking and Reprinting Policy. This occurred on only one side and the correction achieved by the instrumentation was maintained. When grouped by US region, most cases occurred in the Northeast (n = 25, 36.8%), followed by the West (n = 15, 22.1%; Fig. 37. Intraoperative and postoperative complications were recorded by the authors and the results were evaluated by an independent observer. JAMA Intern Med. South Med J 62:17, 1969. 27. Pedicle instrumentation in the thoracolumbar and lumbar spine is a technically challenging procedure. Thankfully, most screws are just misplaced by a millimeter or two out the front or are slightly off medially, so they are not doing real damage. You are talking one of the most complicated area of the law. Epub 2022 Oct 29. In the current series, there were no cases of screw misplacement or vascular or neurologic complications caused by implant application. 2011;213(5):657667. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Clinical Orthopaedics and Related Research411:86-94, June 2003. 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. 20 Tips to Avoid and Handle Problems in the Placement - ScienceDirect Problems in the instrumented segments were considered those occurring from narrowing of the disc space greater than 3 mm, pseudarthrosis, and loss of reduction. 20. 12. One hundred twelve consecutive patients were entered into a retrospective study of instrumented thoracolumbar, lumbar, and lumbosacral spinal arthrodesis at our institution, between September 1994 and January 1999. The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. Morphometric analysis of the proximal thoracic pedicles in Lenke II and IV adolescent idiopathic scoliosis: an evaluation of the feasibility for pedicle screw insertion. Eur Spine J. Patient-specific 3D-printed surgical guides for pedicle screw insertion J Bone Joint Surg 54A:11951204, 1972. Among the plaintiff-awarded cases, 13 (61.9%) were decided by jury trial, 7 (33.3%) by settlement, and 1 (4.8%) by arbitration. Review of neurosurgery medical professional liability claims in the United States. Although the rate of the reported complications was high, the final outcome of the patients was not affected significantly. Malpractice issues in neurological surgery. The last two patients had a T12L1 fracture-dislocation and a L4L5 spondylolytic spondylolisthesis at the site of plug dislodgments. 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. Of note, the award amount for one settlement case was undisclosed. Administrative/technical/material support: Mehta, Wang, KD Than. Pedicle screw instrumentation is widely used for the stabilization of the subaxial cervical, thoracic, and lumbar spine. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders, deformities, and trauma. HHS Vulnerability Disclosure, Help 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. Pedicle screw insertion techniques: an update and review of the Before Median screw misplacement rate was 10% in group A and 13% in group B. Neurosurgery. 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. 2014;20(6):636643. 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. 14. (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. A retrospective review of closed medicolegal cases with verdicts or settlements between 1995 and 2019 was performed using the Westlaw Edge legal research database (Thomson Reuters).7,14,16,23,24 A search of closed federal and state malpractice claims within the Verdicts and Settlements section consisted of the following: spine and surgery and pedicle and screw and fusion and (misplaced or misguided or mispositioned) and surgeon. Inclusion criteria consisted of malpractice claims against surgeons for complications related to misplaced pedicle and/or lateral mass screws. In their meta-analysis of nine randomized controlled trials, Li et al. All Rights Reserved. Svider PF, Kovalerchik O, Mauro AC, et al. 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. Methods. 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. Pullout performance comparison of pedicle screws based on cement A Cotrel-Dubousset spinal system (Medtronic Sofamor Danek, Memphis, TN) was used in all patients and the total number of screws used was 658. All of these patients were asymptomatic and had satisfactory final clinical outcomes (Fig 2). In addition, seven (6.3%) dural tears occurred during the decompression and none occurred during instrumentation. 70% of Pedicle Screws are misplaced - orthostreams.com Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. 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. Per-patient analysis reveals more concerning numbers toward screw misplacement. 17,18,31,39 Edwards 6 showed that solid arthrodesis developed in 96% of patients without previous surgery, whereas 84% of patients having secondary operations experienced a similar result. Please enable it to take advantage of the complete set of features! pedicle screw misplacement malpractice Erwin WD, Dickson JH, Harrington PR: Clinical review of patients with broken Harrington rods. To investigate intraoperative reinsertion of percutaneous pedicle screw (PPS) with intraoperative CT-based navigation and to evaluate the rate of deviation of PPS at postoperative radiographic examination. I won't be at the office but I will check my voice mail. Hecht N, Kamphuis M, Czabanka M, et al. Accessibility Spine 18:983991, 1993. 2012;37(1):6776. An official website of the United States government. Pedicle screw placement: Robotic assistance for greater precision 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. Jury awards $4.5M over misplaced pedicle screw during spine surgery: 5 Gertzbein SD, Robbins SE: Accuracy of pedicular screw placement in vivo. Level of evidence: 1. Moreover, several cases stated that the surgeon used only the anteroposterior or the lateral view, but not both, and the plaintiffs counsel used this information in support of their claim. Clin Orthop 203:4553, 1986. 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. Brodsky AE: Post-laminectomy and post-fusion stenosis of the lumbar spine. One of the patients had a late wound infection develop that was treated by radical debridement and removal of instrumentation. However, only a few complications were related to a poor clinical outcome. (%), Pseudarthrosis requiring revision surgery. Defensive medicine: a culprit in spiking healthcare costs. 2014;96(4):266270. 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. 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. Characteristics of medicolegal cases related to misplaced screws in spine surgery. Error in trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults, Spinal fusion in the United States: analysis of trends from 1998 to 2008, Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws, The accuracy of pedicle screw placement using intraoperative image guidance systems, Accuracy of pedicle screw insertion by AIRO, intraoperative CT in complex spinal deformity assessed by a new classification based on technical complexity of screw insertion, 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, Use of the Airo mobile intraoperative CT system versus the O-arm for transpedicular screw fixation in the thoracic and lumbar spine: a retrospective cohort study of 263 patients, Accuracy and workflow of navigated spinal instrumentation with the mobile AIRO, 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, Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison, Verdict/Settlement Search and Inclusion/Exclusion Criteria, Plaintiff Claim and Index Surgery Information, Impact of Medical Malpractice on Neurosurgeon and Orthopedic Surgeon Careers, Financial Burden of Medical Malpractice Claims Related to Misplaced Pedicle and/or Lateral Mass Screws, Frequency of Misplaced Pedicle and Lateral Mass Screws in Spine Surgery, Strategies to Improve the Accuracy of Screw Placement in Spine Surgery, Top 25 Cited Gamma Knife Surgery Articles - Trigeminal Neuralgia, Top 25 Cited Gamma Knife Surgery Articles - Volume 111, https://doi.org/10.3171/2020.8.FOCUS20600, https://www.bls.gov/data/inflation_calculator.htm, Volume 49 (2020): Issue 5 (Nov 2020): Medicolegal issues in neurosurgery, Single vs multiple misplaced screw(s), no. Previous biomechanical and clinical studies defining junctional segment problems are lacking and consist mainly of case reports. Schatlo B, Molliqaj G, Cuvinciuc V, et al. 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. All these problems were observed only just above the upper instrumentation level and all were observed in patients older than 55 years. Reprint requests to Pavlos Katonis, MD, 99 Minoos & Thenon Street, 71305, Heraklion, Crete, Greece. 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. 2018;83(5):9971006. After the removal of duplicates, a total of 68 unique cases met our inclusion criteria and were included for analysis. Clin Orthop 227:1023, 1988. Yuan HA, Garfin SR, Dickman CA, Mardjetko SM: A historical cohort study of pedicle screw fixation in thoracic, lumbar and sacral spinal fusions. General complications were considered those developing during and after surgery that were not directly related to instrumentation. All the operations were done by one surgeon (PK). This study quantifies the rate of screw misplacement on a per-patient basis to highlight its effect on potential morbidity. Please do not include any confidential or sensitive information in a contact form, text message, or voicemail. Nottmeier EW, Seemer W, Young PM. J Neurosurg Spine. A neurologic deficit developed in one patient (0.9%) who had partial bilateral drop feet after reduction of L4L5 spondylolisthesis. Cotrel Y, Dubousset J, Guillaumat M: New universal instrumentation in spinal surgery. your express consent. The site is secure. 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. Judgment information associated with a defendant (surgeon) versus plaintiff (patient) ruling, trial versus settlement versus arbitration decision, award amount, and time to decision or case closure from index surgery was also recorded. The authors of the current study aimed to describe this impact in the United States, as well as to suggest a potential method for mitigating the problem. The pedicle screws judged as misplacement. a Medial minor perforation 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. Guillain A, Moncany AH, Hamel O, et al. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement. [] The accuracy for free-hand screw placement technique varies from 69% to 94%. Makhni MC, Park PJ, Jimenez J, et al. 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. 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. Your message has been successfully sent to your colleague. Show more. pedicle screws sagittal alignment spinal fusion surgical guides Spinal fusion is used to treat a range of conditions associated with spinal column such as intervertebral disc degeneration and scoliosis [ 1 ]. A total of 47 (69.1%) cases resulted in a decision for the defendant and 21 (30.9%) for the plaintiff. Accuracy of fluoroscopically-assisted pedicle screw placement: analysis of 1,218 screws in 198 patients. 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. 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. 2. A high-low agreement is a settlement in which a defendant agrees to pay the plaintiff a minimum recovery in exchange for the plaintiff agreeing to accept a maximum amount regardless of the trial's outcome. 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. To evaluate the accuracy of pedicle screw placement using a novel classification system to determine potentially significant screw misplacement. Am J Otolaryngol. Retrospective analysis of reasons and revision strategy for failed thoracolumbar fracture surgery by posterior approach: a series of 31 cases. There were no observed cases of screw misplacement outside the pedicle on routine AP and lateral radiographs. Jury Verdict for Doctor for Screw Allegedly Misplaced During Lumbar J Bone Joint Surg 62A:13021307, 1980. Twenty-one patients (18.8%) had thoracolumbar injuries, and loss of immediate postoperative deformity correction ranged from 1.4 to 4.5. Legal liability in iatrogenic orbital injury. The majority of plaintiffs were male (n = 44, 64.7%), and the median age among all cases was 46 years (range 3757 years). 4. Illinois Jury Finds in Favor of Doctor in Gallbladder Surgery that Led to Fatal Bowel Perforation Nickl v. Barry S. Rosen, M.D.
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