Spine 16(8 Suppl):S422427, 1991. laterally placed screws and the azygous vein on the right (T5-T11). Please enable scripts and reload this page. On average, physicians spend nearly 11 percent of their 40-year careers with an open, unresolved malpractice claim. 2005;293(21):26092617. Cookie Policy. Eur Spine J. The medicolegal landscape of spine surgery: how do surgeons fare? Medical malpractice litigation has made a significant impact on spine surgery, with many spine surgeons avoiding complex cases or practicing other defensive medicine tactics in an effort to avoid being sued.5 Moreover, the majority of neurosurgeons spend more than 10% of their annual revenue on malpractice insurance,1,14 and the excessive financial risk of litigation is even leading some insurers to no longer offer coverage to spine surgeons.19 A 2011 study in the New England Journal of Medicine found that 19.1% of neurosurgeons are named as a defendant in a malpractice suit each year (highest of any specialty).12 Moreover, 88% of physicians in high-risk specialties, like neurosurgery, are involved in a lawsuit by age 45, increasing to a concerning 99% by 65 years of age.12 Such litigation places a substantial financial, temporal, and emotional burden on physicians in high-risk specialties, with studies showing that up to 72% of neurosurgeons1 admitted that their fear of litigation significantly influenced their practice,25 with many avoiding high-risk patients altogether.1 Similarly, Nahed 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. 2014;75(6):609613. Pedicle screw fixation is an effective but demanding method to treat various spinal disorders and is associated with a significant complication rate. 24. 30. 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. 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. The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. In the current series, there were no cases of screw misplacement or vascular or neurologic complications caused by implant application. However, 5-10% of those misplaced screws are cause for concern." "To rectify this, we must have access to imaging devices during the procedure. J Bone Joint Surg 54A:11951204, 1972. N Engl J Med. 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. It argued that the foot drop was unavoidable and due to the surgeons need to manipulate the right L5 nerve root in order to remove Nyquists herniated disc during the spinal fusion surgery. 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. 23. Spine (Phila Pa 1976). 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. Both of these patients complained of thigh pain but refused any additional surgery. Reviewed submitted version of manuscript: all authors. Hadjipavlou A, Enker P, Dupuis P, Katzman S, Silver J: The causes of failure of lumbar transpedicular spinal instrumentation and fusion: A prospective study. Spine 18:983991, 1993. Pedicle screw placement is a common procedure. doi: 10.1097/BRS.0b013e31822a2e0a. J Bone Joint Surg 62A:13021307, 1980. Grubb SA, Lipscomb HJ: Results of lumbosacral fusion for degenerative disc disease with and without instrumentation: Two- to five-year follow-up. 1. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. 4. Arthrodesis was questionable in eight asymptomatic patients (7.1%). Louw JA, Dommissee GF, Roos MF: Spinal stenosis following anterior spinal fusion. All Rights Reserved. 38. Re: malpositioned pedicle screw resulting in additional surgery and disability. J Neurosurg Spine. 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. 3. 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. In White AH, Rothman RH, Ray CD (eds). Three slender patients complained of soft tissue irritation and a bothersome prominence because of the screws bulky profile. Li HM, Zhang RJ, Shen CL. McAfee PC, Weiland DJ, Carlow JJ: Survivorship analysis of pedicle spinal instrumentation. What can spine surgeons do to improve patient care and avoid medical negligence suits? In addition, hardware failures were observed in 12 patients (10.7%), junctional problems were seen in five patients (4.5%), problems in the instrumented segments were seen in 39 patients (34.7%), and problems of balance occurred in five patients (4.5%). A total of 247 screws (9.07%) were BMP, 52 (1.91%) were IMP, and 29 (1.06%) were considered SAR. Personal consequences of malpractice lawsuits on American surgeons. 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. 2011;365(7):629636. 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. Am J Transl Res. 2013;34(6):699705. Most of these complications were minor and with the exception of two misplaced screws, did not contribute to the occurrence of neurologic impairment or severe pain. Facebook Google Plus Youtube RSS Email. Examples of both laterally and medially misplaced lumbar pedicle screws are provided in Fig. Clinical Orthopaedics and Related Research411:86-94, June 2003. Among the plaintiff-awarded cases, 13 (61.9%) were decided by jury trial, 7 (33.3%) by settlement, and 1 (4.8%) by arbitration. 22. There were no observed cases of screw misplacement outside the pedicle on routine AP and lateral radiographs. 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%). This device was used with an early version of the Cotrel-Dubousset instrumentation to provide sacral fixation and it is rarely used since the more widespread use of newer spine fixation systems. The patient suffered permanent nerve damage as a result of the puncture. 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. J Spine Surg. Wiltse LL, Spencer CW: New uses and refinements of the paraspinal approach to the lumbar spine. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiff's spine. Spinal fusion in the United States: analysis of trends from 1998 to 2008. Copyright 2023 Becker's Healthcare. HHS Vulnerability Disclosure, Help Although the rate of the reported medical complications was high (36.5%), these did not significantly affect the final clinical outcome of the current patients. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement. Please enable it to take advantage of the complete set of features! Neurologic injury. None of these complications resulted in additional surgery or in a significant increase of morbidity. Morphometric analysis of the proximal thoracic pedicles in Lenke II and IV adolescent idiopathic scoliosis: an evaluation of the feasibility for pedicle screw insertion. Clin Orthop 115:130139, 1976. Moffatt-Bruce SD, Ferdinand FD, Fann JI. Ann Thorac Surg. 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. Rothberg MB, Class J, Bishop TF, et al. NCI CPTC Antibody Characterization Program. 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. Spine 6:615619, 1981. Three-dimensional printing versus freehand surgical techniques in the surgical management of adolescent idiopathic spinal deformity. 7. 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. Fager CA. 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 ]. matte black square deadbolt; roberts point park fishing report; qr code on binax covid test; mff premium character list. Neurosurgery. 2020;45(2):E111E119. 15. Yuan HA, Garfin SR, Dickman CA, Mardjetko SM: A historical cohort study of pedicle screw fixation in thoracic, lumbar and sacral spinal fusions. 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. Per-patient analysis reveals more concerning numbers toward screw misplacement. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiffs spine. Unauthorized use of these marks is strictly prohibited. Subjects were 10,754 patients (73,777 pedicle screws) who underwent PSF at 11 hospitals over 15 years. Show more. The literature gave a range of screw misplacement rates detected on postoperative imaging of between 1% and 18%, with the rate generally considered to be around 10%. 39. Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. Fishers exact test and the Mann-Whitney U-test were used for the analysis of categorical and continuous data, respectively, except when an unpaired t-test was utilized for analyses related to normalized, nominal, and inflation-adjusted award totals. Zucherman J, Hsu K, Picetti III G, et al: Clinical efficacy of spinal instrumentation in lumbar degenerative disc disease. single homes for sale in lehigh valley, pa single homes for sale in lehigh valley, pa Home Realizacje i porady Bez kategorii single homes for sale in lehigh valley, pa Clin Orthop 203:7598, 1986. They both had motor deficits from which 1 patient recovered completely. 2014;20(6):636643. 2018;27(9):23392347. (A) Anteroposterior and (B) lateral radiographs show coronal imbalance that developed 4 years after surgery in a 57-year-old woman with L3L4 float fusion. And while the offending screw was removed the next day, Nyquist continued to experience right foot drop, along with lower back pain and sciatica, i.e. Studdert DM, Mello MM, Sage WM, et al. pedicle screw misplacement malpractice. 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. Finally, considering the problems of balance, it seems that failure to properly evaluate any preexisting scoliosis was a main cause of this important complication. Segal J. 21. A p < 0.05 was considered statistically significant. Bydon M, Xu R, Amin AG, et al. Adjusted for age and preoperative Cobb angle, patients with a higher misplacement rate were more likely to have screws . Guzek RH, Mitchell SL, Krakow AR, Harshavardhana NS, Sarkissian EJ, Flynn JM. Determining legal responsibility in otolaryngology: a review of 44 trials since 2008. 2013;32(1):111119. The link was not copied. 36. ABSTRACT: Pedicle screw loosening has been implicated in recurrent back pain after lumbar spinal fusion, but the degree of loosening has not been systematically quantied in patients. Clin Orthop 284:8090, 1992. 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. However, only a few complications were related to a poor clinical outcome. 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. 2014 Sep;21(3):320-8. doi: 10.3171/2014.5.SPINE13567. 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. 2014;96(4):266270. 1). 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. Balch CM, Oreskovich MR, Dyrbye LN, et al. Descriptive analysis of state and federal spine surgery malpractice litigation in the United States. This occurred on only one side and the correction achieved by the instrumentation was maintained. and transmitted securely. Of note, the award amount for one settlement case was undisclosed. Linking and Reprinting Policy. A total of 2396 screws were placed accurately (87.96%). Abstract BACKGROUND CONTEXT Surgeons have increasingly adopted robotic-assisted lumbar spinal fusion due to indications that robotic-assisted surgery can reduce pedicle screw misplacement. Would you like email updates of new search results? Quinnell RC, Stockdale HR: Some experimental observations of the influence of a single lumbar floating fusion on the remaining lumbar spine. Steffee AD, Biscup RS, Sitkowski DJ: Segmental spine plates with pedicle screw fixation: A new internal fixation device for disorders of the lumbar and thoracolumbar spine. Laryngoscope. Pedicle screw placement safety with the aid of patient-specific guides in a case series of patients with thoracic scoliosis. 2017;42(3):177185. 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. Sub-analysis of adolescent idiopathic scoliotic patients showed no curve or patient characteristic that correlated with IMP or SAR. leg pain. Hecht N, Kamphuis M, Czabanka M, et al. Bethesda, MD 20894, Web Policies West et al 33 also reported a 29% complication rate for the first 50 patients and a 26% complication rate for the last 74 patients. Smith TR, Hulou MM, Yan SC, et al. Spine J. 0 attorneys agreed. 2012 Feb 1;37(3):E188-94. 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. Scarone P, Vincenzo G, Distefano D, et al. 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? The screws were needed to stabilize the spine and fix the fused vertebrae in place. When adjusted for inflation, these values increased to $1,330,201 $882,023 versus $970,832 $381,619, respectively (p = 0.32; Fig. 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. You are talking one of the most complicated area of the law. Spine 13:952953, 1988. In this example, the surgeon replaced the misplaced screw prior to leaving the operating room, which arguably played a significant role in the jury ruling in favor of the defendant (surgeon). J Pediatr Orthop. Can Postoperative Radiographs Accurately Identify Screw Misplacements? 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. EOS System Courtesy of EOS imaging. Federal government websites often end in .gov or .mil. Also notable, only one claim reported the use of intraoperative CT and was ultimately ruled in favor of the defendant. This patient recovered completely in 6 weeks. Comparetto, Esq., 727-328-7900, www.florida-malpractice-lawyers.com. J Neurosurg Spine. 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. Pedicle screw construct have become one of the most practiced procedure in spinal surgery. Per-patient analysis showed 23 (18.11%) of patients had all screws AP. Melissa Nyquist required a lumbar back fusion for a herniated disc at the L4-5 level. 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. What can spine surgeons do to improve patient care and avoid medical negligence suits? The accuracy of pedicle screw placement using intraoperative image guidance systems. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders, deformities, and trauma. Defensive medicine in neurosurgery: the Canadian experience. When grouped by US region, most cases occurred in the Northeast (n = 25, 36.8%), followed by the West (n = 15, 22.1%; Fig. It is indicated that screws medially misplaced at a distance greater than 2-mm, especially 4 mm, may be a cause of negative effects on the neural structure and should be removed during the early phase of the postoperative period, even among patients without postoperative neurological abnormalities. All the operations were done by one surgeon (PK).