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Device Problem
Fluid/Blood Leak (1250)
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Patient Problems
Pulmonary Embolism (1498); Abdominal Pain (1685)
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Event Type
Injury
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Manufacturer Narrative
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Literature citation: endovascular retrieval of intracaval cement: a fishing net technique by andrej isaak, martin takes, david kingsmore, lorenz gurke.Initial reporter- clinical specialist.Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Pre-operative diagnosis: degenerative vertebral disease presented with acute spondylolisthesis due to an l5/s1 fracture procedure used: cement-augmented vertebral stabilization and pedicle screw fixation it was reported via a literature study that a patient with degenerative vertebral disease presented with acute spondylolisthesis due to an l5/s1 fracture, wherefore a cement-augmented vertebral stabilization and pedicle screw fixation were performed.During spinal surgery, cement leakage into perivertebral tissue was noted at l5 level, and the application was therefore stopped.A ct scan performed on day 3 after spinal surgery due to diffuse abdominal pain revealed a 10-cm-long cement fragment in the inferior vena cava, with a 2-cm cranial portion attached by a thin filament, that was floating freely above the level of the renal vein.Furthermore, a small 4-mm cement fragment was detected in the segmental lobar superior left pulmonary artery, indicative for pulmonary embolization of cement.
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Search Alerts/Recalls
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