Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. All the operations were done by one surgeon (PK). Pedicle screw accuracy in thoracolumbar fractures- is routine 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. 1. Sethi MK, Obremskey WT, Natividad H, et al. This patient recovered completely in 6 weeks. 28. J Bone Joint Surg 45A:11591170, 1963. Dalenberg DD, Asher MA, Robinson RG, Jayaraman G: The effect of a stiff spinal implant and its loosening on bone mineral content in canines. 35. Louw JA, Dommissee GF, Roos MF: Spinal stenosis following anterior spinal fusion. The average age of the patients was 47 years and the average followup was 35 months. Preparation. 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. Abstract BACKGROUND CONTEXT Surgeons have increasingly adopted robotic-assisted lumbar spinal fusion due to indications that robotic-assisted surgery can reduce pedicle screw misplacement. J Spine Surg. All Rights Reserved. 2002;27(22):24252430. Litigation resulted in average payouts of $1,204,422 $753,832 between 1995 and 2019, when adjusted for inflation. The total number of reoperations for MPS and patient clinical data were obtained from medical records at each hospital. 2009;10(1):3339. Breakage of a divergent screw of a Chopin block at the lumbosacral area was seen 3 months after surgery. Katonis PG, Kontakis GM, Loupasis GA, et al: Treatment of unstable thoracolumbar and lumbar spine injuries using Cotrel-Dubousset instrumentation. All of these patients were asymptomatic and had satisfactory final clinical outcomes (Fig 2). 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. Cotrel Y, Dubousset J, Guillaumat M: New universal instrumentation in spinal surgery. Zdeblick 38 also reported an overall arthrodesis rate of 65% in patients without instrumentation, 77% in patients with semirigid fixation, and 95% in patients with a rigid constrained screw-rod system. Excessive hemorrhage occurred in two patients (1.8%) with coagulation disorders. 2012;21(suppl 2):S196S199. Summary of background data: NCI CPTC Antibody Characterization Program. Copyright 2023 Becker's Healthcare. 20 Tips to Avoid and Handle Problems in the Placement - ScienceDirect The median time to case closure was longer for defendant-awarded cases, but this finding was not statistically significant (61.5 vs 56.3 months, p > 0.05). N Engl J Med. Please do not include any confidential or sensitive information in a contact form, text message, or voicemail. Patient safety: disclosure of medical errors and risk mitigation. Neurosurgery. Pedicle screw fixation is an effective but demanding method to treat various spinal disorders and is associated with a significant complication rate. In patients with degenerative conditions, all of the affected segments were included in the instrumentation and each vertebra was fixed with two pedicle screws. 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. 18. A total of 247 screws (9.07%) were BMP, 52 (1.91%) were IMP, and 29 (1.06%) were considered SAR. Spine (Phila Pa 1976). 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. 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. Segal J. The majority of plaintiffs were male (n = 44, 64.7%), and the median age among all cases was 46 years (range 3757 years). Amount awarded to plaintiffs by US region, adjusted for inflation as of April 2020. pedicle screw misplacement malpractice 2021 Jul 1;41(Suppl 1):S80-S86. However, the highest offer had been a combined $300,000 from the two defendants. 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. 2017 Mar;5(2):109-116. doi: 10.1016/j.jspd.2016.10.007. Spine J. Pedicle screw insertion in the thoracolumbar spine. However, the misplacement of pedicle screws can lead to disastrous complications. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. This demonstrates technical ability but does not represent the impact of screw misplacement on individual patients. The last two patients had a T12L1 fracture-dislocation and a L4L5 spondylolytic spondylolisthesis at the site of plug dislodgments. Forty-seven intraoperative and medical complications were observed in 41 patients (36.6%). In the other patient, L4L5 float arthrodesis was done. Federal government websites often end in .gov or .mil. Quinnell RC, Stockdale HR: Some experimental observations of the influence of a single lumbar floating fusion on the remaining lumbar spine. (A) Anteroposterior and (B) lateral radiographs taken 2 years after surgery show unilateral pseudarthrosis in a 55-year-old man with spinal stenosis. 22. Thu, May 27th, 2021. 12. . 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. On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. Am J Otolaryngol. Defendant-awarded cases by US region (right). 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). Misplacement rates have been reported to be from 5 to 41% in the lumbar spine and from 3 to 55% in the . 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. Finally, considering the problems of balance, it seems that failure to properly evaluate any preexisting scoliosis was a main cause of this important complication. 2018;29(4):397406. 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. Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort. The medicolegal landscape of spine surgery: how do surgeons fare? The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. single homes for sale in lehigh valley, pa 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. What can spine surgeons do to improve patient care and avoid medical negligence suits? Unauthorized use of these marks is strictly prohibited. Of note, the award amount for one settlement case was undisclosed. The intent is to provide relief from pain and nerve damage. In five patients with thoracolumbar injuries, who were the first treated in the current series, and in four patients with fractures in the lower lumbar spine, two-segment fixation was used. A total of 47 (69.1%) cases resulted in a decision for the defendant and 21 (30.9%) for the plaintiff. J Neurosurg Spine. Spine 18:18621866, 1993. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. Cerebrospinal fluid fistulas. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. J Neurosurg Spine. 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. Jena AB, Seabury S, Lakdawalla D, Chandra A. 2012 Feb 1;37(3):E188-94. 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. One of the common means of doing so is to place a screw into each of two adjacent spinal bones (vertebrae), and then a rod between them. Waddell G, Kummell EG, Lotto WN, et al: Failed lumbar disc surgery and repeat surgery following industrial injuries. 14. It has a great developing technique that is used for fixation and fusion in spine surgery. Aigner R, Bichlmaier C, Oberkircher L, Knauf T, Knig A, Lechler P, Ruchholtz S, Frink M. BMC Musculoskelet Disord. Daniels AH, Ruttiman R, Eltorai AEM, et al. What can spine surgeons do to improve patient care and avoid medical negligence suits? There were two complete degenerations of the upper disc, one central canal stenosis, and two asymptomatic disc space narrowings and retrolistheses. Studdert DM, Mello MM, Sage WM, et al. 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). Scarone P, Vincenzo G, Distefano D, et al. Clin Orthop 115:130139, 1976. 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. Erwin WD, Dickson JH, Harrington PR: Clinical review of patients with broken Harrington rods. Ultimately, no significant differences were seen in inflation-adjusted award information between plaintiff and defendant (Table 3). However, published reports are increasingly demonstrative of the positive effect of pedicle fixation on arthrodesis and successful outcome in the treatment of patients with these disorders. McLaughlin WM, Donnelley CA, Yu K, Gillinov SM, Tuason DA. 2016;102(2):358362. Svider PF, Husain Q, Kovalerchik O, et al. Although pedicle screw fixation opened a new horizon of spinal surgery by providing rigid fixation of the spine, it is a technically demanding procedure with potential complications including medical complications, hardware and technical problems, and long-term changes of junctional motion segments. One hundred four of the 112 patients had a posterior procedure. Nayar G, Blizzard DJ, Wang TY, et al. Of note, the award amount for one settlement case was undisclosed. Pedicle screw placement is a common procedure. 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. The pedicle screws judged as misplacement. a Medial minor perforation The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. Cookie Policy. Jury awards $4.5M over misplaced pedicle screw during spine surgery: 5 Linking and Reprinting Policy. Malpractice liability and defensive medicine: a national survey of neurosurgeons. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders, deformities, and trauma. 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. Rynecki ND, Coban D, Gantz O, et al. Hardware-related failures were observed in 12 patients (10.7%). Problems in the instrumented segments were considered those occurring from narrowing of the disc space greater than 3 mm, pseudarthrosis, and loss of reduction. Spine (Phila Pa 1976). Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. After the removal of duplicates, a total of 68 unique cases met our inclusion criteria and were included for analysis. pedicle screw: A rigid surgical implant used to stabilize adjacent spinal segments in spinal fusion surgery. The suit claimed Dr. Friedlander failed to diagnose and treat the mispositioned screw in a timely manner, leading the plaintiff to develop pain in his right leg, numbness in his right calf and weakness in his right toes.

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