Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Type
Injury
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Manufacturer Narrative
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Literature citation: ryo kitagawa (effectiveness of balloon kyphoplasty for vertebral fracture with neurological disorder) mean age: 80 years old (74-88); 10 females, 1 male neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.
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Event Description
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It was written in an abstract that total of 116 patients underwent balloon kyphoplasty in this hospital from 2011 jan to 2014 nov.Of those, 11 patients with neurological symptoms in lower limbs were subjected in this study.Post-operatively, three patient's symptoms did not improve.No malfunction of the product is reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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