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Model Number UNK_NAV_SYS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Embolus (1830); Bone Fracture(s) (1870); Pain (1994); Thrombosis (2100)
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Event Date 09/20/2018 |
Event Type
Injury
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Manufacturer Narrative
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Patient age is the mean value of the age of the patient(s) in the study.Patient gender is the majority value of the patient(s) in the study.Patient weight not available from the site.Event date is the accepted date of the literature article.Device lot number, or serial number, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.Concomitant medical products: product id: unk_oarm_sys, serial/lot #: unk, ubd: , udi#: if information is provided in the future, a supplemental report will be issued.
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Event Description
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Citation ori barzilai, md lily mclaughlin, bs eric lis, md anne s.Reiner, mph mark h.Bilsky,md ilya laufer,md utility of cement augmentation via percutaneous fenestrated pedicle screws for stabilization of cancer-related spinal instability.Operative neurosurgery; volume 16, number 5, may 2019 background: cancer patients experience pathological fractures and the typical poor bone quality frequently complicates stabilization.Methods for overcoming screw failure include utilization of fenestrated screws that permit the injection of bone cement into the vertebral body to augment fixation.Objective: to evaluate the safety and efficacy of cement augmentation via fenestrated screws.Methods: a retrospective chart review of patients with neoplastic spinal instability who underwent percutaneous instrumented stabilization with cement augmentation using fenestrated pedicle screws.Patient demographic and treatment data and intraoperative and postoperative complications were evaluated by chart review and radiographic evaluation.Prospectively collected patient reported outcomes (pro) were evaluated at short (2- <(><<)>6 mo) and long term (6-12 mo).Results: cement augmentation was performed in 216 fenestrated pedicle screws in 53 patients.Three patients required reoperation.One patient had an asymptomatic screw fracture at 6 mo postoperatively that did not require intervention.No cases of lucency around the pedicle screws, rod fractures, or cement extravasation into the spinal canalwere observed.Eight cases of asymptomatic, radiographically-detected venous extravasation were found.Systemic complications included a pulmonary cement embolism, a lower extremity deep vein thrombosis, and a postoperative mortality secondary to pulmonary failure fromwidespread metastatic pulmonary infiltration.Significant improvement in pro measures was found in short and long-term analysis.Conclusion: cement augmentation of pedicle screws is an effectivemethod to enhance the durability of spinal constructs in the cancer population.Risks include cement extravasation into draining blood reported events: 1) one case of in-house mortality was documented secondary to pulmonary failure from widespread metastatic infiltration of the lungs with no evidence of pe or other cement related toxicities.(703446157) 2) one instance of a lower extremity deep vein thrombosis (dvt) that was likely unrelated to the instrumentation.3) one instance of recurring mechanical back pain where a hardware revision procedure was conducted.4) one instance of revision of instrumentation secondary to a fracture of an instrumented pedicle 1 mo after the initial surgery.5) one instance of a wound revision due to dehiscence while receiving bevacizumab.6) one instance where asymptomatic radiological found evidence of a broken pedicle screw 6 mo after surgery and did not require inte rvention.7) seven instances of cement extravasation into draining vessels.8) one instance of cement extravasation into draining vessels where there was evidence of cement embolus in the pulmonary artery.
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Search Alerts/Recalls
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