Agarwal Aakash, Kelkar Amey, Garg Agarwal Ashish, Jayaswal Daksh, Jayaswal Arvind, Shendge Vithal
Department of Bioengineering and Orthopaedics Surgery, University of Toledo, Toledo, USA.
Department of Orthopedics, Primus Super Speciality Hospital, New Delhi, India.
Spine Surg Relat Res. 2019 Oct 20;4(2):148-151. doi: 10.22603/ssrr.2019-0041. eCollection 2020.
Recent literature identifies similar failure rates such as anchor pull-out and rod breakage, but a higher unplanned revision surgery with MAGEC rods than with traditional growth rods. Besides known failure modes such as rod fracture, infection, etc., failure to noninvasively distract the rods was cited as the main cause of such unplanned surgeries. The source of these data ranges from multicenter cohort studies to singular case series. These studies included explanted implants that had undergone failure in distraction mechanism, rod fracture, or infection, or had reached their maximum length. Nevertheless, in addition to identifying the overall mode of failure, it is equally important to identify the large-scale incidence of exclusive failures in comparison with standard instrumentation failure modes in spine surgery.
The US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) databases were searched for reports on MAGEC rods, and on standard instrumentation used for spinal fusion. The adverse events were recorded, tabulated, and analyzed.
A search of the US FDA MAUDE database yielded reports of 163 device-related adverse events. These included distraction mechanism failure (n=129), rod fracture (n=24), and minor voluntary reports of infection and tissue discoloration (n=10). For standard instrumentation usage in spine surgery, pedicle screw breakage post surgery (n=336), set screw damage during surgery (n=257), rod breakage post surgery (n=175), interbody cage breakage during surgery (n=118), and pedicle screw breakage during surgery (n=75) were identified as the top 5 failure modes.
The study identified the distraction mechanism failure as the most common and growing complication associated with MAGEC rod usage in children with scoliosis, leading to unplanned invasive revision surgeries.
近期文献指出，诸如锚钉拔出和棒体断裂等失败率相似，但与传统生长棒相比，MAGEC棒的非计划翻修手术率更高。除了已知的失败模式，如棒体断裂、感染等，未能对棒体进行无创撑开被认为是此类非计划手术的主要原因。这些数据来源广泛，从多中心队列研究到单病例系列。这些研究包括因撑开机制失败、棒体断裂或感染而失败的取出植入物，或已达到其最大长度的植入物。然而，除了确定总体失败模式外，与脊柱手术中的标准器械失败模式相比，确定排他性失败的大规模发生率同样重要。
检索美国食品药品监督管理局（FDA）的制造商和用户设施设备经验（MAUDE）数据库，以获取有关MAGEC棒以及用于脊柱融合的标准器械的报告。记录、列表并分析不良事件。
对美国FDA的MAUDE数据库进行检索，得到了163例与器械相关的不良事件报告。其中包括撑开机制失败（n = 129）、棒体断裂（n = 24）以及少量关于感染和组织变色的自愿报告（n = 10）。对于脊柱手术中标准器械的使用，术后椎弓根螺钉断裂（n = 336）、术中固定螺钉损坏（n = 257）、术后棒体断裂（n = 175）、术中椎间融合器断裂（n = 118）以及术中椎弓根螺钉断裂（n = 75）被确定为前5种失败模式。
该研究确定撑开机制失败是与脊柱侧弯患儿使用MAGEC棒相关的最常见且不断增加的并发症，会导致非计划的侵入性翻修手术。
