This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. 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. The purpose of current study was to analyze the complications and problems during and after pedicle screw fixation for various spinal disorders and trauma. Review of neurosurgery medical professional liability claims in the United States. 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. N Engl J Med. 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). Spine (Phila Pa 1976). Disclaimer. Sub-analysis of adolescent idiopathic scoliotic patients showed no curve or patient characteristic that correlated with IMP or SAR. This study revealed an overall accuracy rate of 95.2% of mainly percutaneously inserted pedicle screws according to the classification of Zdichavsky et al. Misplacement of Pedicle Screws Leads to Years of Pain and Opioid Addiction Nationally Recognized Regionally Dominant Contact Us Now For a Free Consultation Over $850 Million in Verdicts and Settlements Home Articles Misplacement of Pedicle Screws Leads to Years of Pain and Opioid Addiction 30. 2021 Nov;9(6):1541-1548. doi: 10.1007/s43390-021-00377-5. The rate of medical complications was 8%. Gertzbein SD, Robbins SE: Accuracy of pedicular screw placement in vivo. Spine 17:349355, 1992. 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. Pedicle screw construct have become one of the most practiced procedure in spinal surgery. Can Postoperative Radiographs Accurately Identify Screw Misplacements? Your current browser may not support copying via this button. Zucherman J, Hsu K, Picetti III G, et al: Clinical efficacy of spinal instrumentation in lumbar degenerative disc disease. Ann R Coll Surg Engl. 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. 2012;41(2):6973. 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. 2014 Aug 1;14(8):1702-8. doi: 10.1016/j.spinee.2014.03.044. Breakage of a divergent screw of a Chopin block at the lumbosacral area was seen 3 months after surgery. 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. J Spine Surg. J Bone Joint Surg 73A:11791184, 1991. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). This site needs JavaScript to work properly. $ = US$. 2. Seabury SA, Chandra A, Lakdawalla DN, Jena AB. Phone/Fax: 30-2810-318361; E-mail: [emailprotected]. 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. 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. Spine 14:472476, 1989. pedicle screw misplacement malpractice. 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. Svider PF, Kovalerchik O, Mauro AC, et al. Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. 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. 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. Linking and Reprinting Policy. Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. The median time to case closure was 56.3 (35.267.2) months when ruled in favor of the plaintiff (i.e., patient) compared to 61.5 (51.477.2) months for defendant (surgeon) verdicts (p = 0.117). 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. Twenty-one patients (18.8%) had thoracolumbar injuries, and loss of immediate postoperative deformity correction ranged from 1.4 to 4.5. Dr. Abd-El-Barr is a consultant for Spineology. Malpractice claims in spine surgery in Germany: a 5-year analysis. Would you like email updates of new search results? 18. In the other patient, L4L5 float arthrodesis was done. A retrospective review of charts, x-rays (XRs) and computed tomography (CT) scans was performed. The third surgical procedure removed the pedicle screws but left the patient in an unfused state with an unstable spine. Bydon M, Xu R, Amin AG, et al. None of these complications resulted in additional surgery or in a significant increase of morbidity. Spine Deform. J Bone Joint Surg 62A:13021307, 1980. However, the defendant doctor maintained that Nyquists foot drop was not caused by the misplaced screw. Forty-seven general complications were seen in 41 patients (36.5%). Per-patient analysis showed 23 (18.11%) of patients had all screws AP. 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. However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. 26 They support that after a lengthy symptom-free period, segments next to a fused segment can break down and the segment next to the adjacent segment is almost as likely to break down as the adjacent segment. Intraoperative and postoperative complications were recorded by the authors and the results were evaluated by an independent observer. 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. Acquisition of data: Sankey. Feb. 16, 2021 Accurate placement of pedicle screws is key to avoiding the potential complications of spinal fusion surgery and improving overall spinal fixation. Before Problems in the instrumented segments were considered those occurring from narrowing of the disc space greater than 3 mm, pseudarthrosis, and loss of reduction. 4). 1 To be effective, the pedicle screw constructs must withstand intraoperative loading and physiological forces due to daily postoperative activities. Please do not include any confidential or sensitive information in a contact form, text message, or voicemail. Spine 19(20 Suppl):2279S2296, 1994. 2011;365(7):629636. In our opinion, these problems may be prevented by applying the following principles: limitation of spine arthrodesis to the pathologic levels, inclusion of already extensive changes at the level above or below the planned arthrodesis into the arthrodesis, restoration of postoperative sagittal and coronal alignment, and avoidance of impingement syndrome from the adjacent nonfused facets. While the majority of verdicts are found in favor of the defendant (surgeon), over 30% of cases in this study were found in favor of the plaintiff (patient), resulting in average inflation-adjusted payouts of over $1.2 million per claim over the past 25 years. Harrington PR, Tullos HS: Reduction of severe spondylolisthesis in children. Hadjipavlou A, Enker P, Dupuis P, Katzman S, Silver J: The causes of failure of lumbar transpedicular spinal instrumentation and fusion: A prospective study. PLoS One. Comparetto, Esq., 727-328-7900, www.florida-malpractice-lawyers.com. Junctional problems were recorded as pathologic changes of the adjacent motion segments, just above and below the instrumented and fused segments. Your message has been successfully sent to your colleague. We also investigated the effect of bone mineral density (BMD), diameter of pedicle screws, and the region of spine on the pullout strength of pedicle screws. A rod is used to hold the vertebra together to allow fusion to occur. Neurosurgery. 16. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Federal government websites often end in .gov or .mil. Epub 2022 Oct 29. 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. However, despite the apparent widespread use of pedicle system fixation, few studies of problems and particularly complications have been published. 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). Accuracy and workflow of navigated spinal instrumentation with the mobile AIRO CT scanner. Excessive hemorrhage occurred in two patients (1.8%) with coagulation disorders. Three-dimensional printing versus freehand surgical techniques in the surgical management of adolescent idiopathic spinal deformity. Pedicle screw placement safety with the aid of patient-specific guides in a case series of patients with thoracic scoliosis. The average followup was 35 months (range, 1851 months). The accuracy rate of pedicle screw (PS) placement varies from 85% to 95% in the literature. National Library of Medicine 3. 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. A total of 47 (69.1%) cases resulted in a decision for the defendant and 21 (30.9%) for the plaintiff. Orthopedics. 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. Spine (Phila Pa 1976). This retrospective study analyzes the complications and the problems developed during and after pedicle screw fixation in patients with spinal disorders and trauma. One hundred four of the 112 patients had a posterior procedure. Thirty-five (27.56%) had IMP and 18 (14.17%) had SAR. 3. Koktekir E, Ceylan D, Tatarli N, Karabagli H, Recber F, Akdemir G. Spine J. 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 Spine J. Plaintiff's expert was prepared to testify at trial that these complaints are characteristic of a malpositioned screw impinging upon a neural structure. 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. Malpractice litigation and the spine: the NHS perspective on 235 successful claims in England. Call me tomorrow. 2014;75(6):609613. 5. Edmunds I, Cummine J, Fearnside M: Prevention of dislodgement of Cotrel-Dubousset rods from tulip screws. 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. Cerebrospinal fluid fistulas. Please try again soon. 34. and 17.1% of the patients included had at least one screw misplaced. 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. In six patients (5.3%) with degenerative spine disease, the disc material had been removed. (%), Pseudarthrosis requiring revision surgery. Eur Spine J. Risk factor analysis showed smaller Cobb angles increased likelihood of all screws being AP. Eur Spine J. Spine 18:23252326, 1993. [] The accuracy for free-hand screw placement technique varies from 69% to 94%. 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. The rate of reoperation for screw misplacement per screw was 0.17%. In addition, seven (6.3%) dural tears occurred during the decompression and none occurred during instrumentation. The initial search using the terms above returned 3654 cases. 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. government site. PURPOSE This study aimed to compare rates of perioperative complications between robotic-assisted and conventional . Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. Misplacement rates have been reported to be from 5 to 41% in the lumbar spine and from 3 to 55% in the . 6 J Neurosurg. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. 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. Hecht N, Kamphuis M, Czabanka M, et al. Complications were classified as general, hardware-related, problems associated with the instrumented segments, junctional level problems, and problems related with balance (Table 2). 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. Per-patient analysis reveals more concerning numbers toward screw misplacement. Median screw misplacement rate was 10% in group A and 13% in group B. 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. This occurred on only one side and the correction achieved by the instrumentation was maintained. 2020;45(2):E111E119. Mason A, Paulsen R, Babuska JM, et al. 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. Edwards CC: Spinal screw fixation of the lumbar and sacral spine: Early results treating the first 50 cases. Larson AN, Santos ER, Polly DW Jr, Ledonio CG, Sembrano JN, Mielke CH, Guidera KJ. Results. 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. Spine J. The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. Pedicle screw placement is a common procedure. Sethi MK, Obremskey WT, Natividad H, et al. However, the highest offer had been a combined $300,000 from the two defendants. Defensive medicine in neurosurgery: the Canadian experience. Spine 13:952953, 1988. The rod is held in place by "pedicle screws," which the surgeon must insert into the pedicles. 2012;89(10):7071. J Bone Joint Surg 54A:11951204, 1972. 32. 2020;162(6):13791387. 25. PMC Both of these patients complained of thigh pain but refused any additional surgery. 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. In the current series, there were no cases of screw misplacement or vascular or neurologic complications caused by implant application. 2018;27(9):23392347. Each case was then carefully screened for relevance and sufficient data. All the operations were done by one surgeon (PK). After the removal of duplicates, a total of 68 unique cases met our inclusion criteria and were included for analysis. shooting in valdosta leaves one dead 38. Hsu K, Zucherman JF, White AH: Internal Fixation With Pedicle Screws. Insuring spinal neurosurgery. You are talking one of the most complicated area of the law. Clin Orthop 203:717, 1986. Clin Orthop 227:1023, 1988. 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. Results: An official website of the United States government. Pediatric pedicle screw placement using intraoperative computed tomography and 3-dimensional image-guided navigation. Malpractice issues in neurological surgery. Yuan HA, Garfin SR, Dickman CA, Mardjetko SM: A historical cohort study of pedicle screw fixation in thoracic, lumbar and sacral spinal fusions. 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. A total of 247 screws (9.07%) were BMP, 52 (1.91%) were IMP, and 29 (1.06%) were considered SAR. 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.
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Alexander Von Auersperg, Articles P