Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fever (1858); Unspecified Infection (1930); Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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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 reported in an abstract, post-op, two months after l1 balloon kyphoplasty surgery the patient had low-grade fever and lumbar backache.Blood test showed increased white blood cell count:12000 and c-reactive protein 6.8, so it was diagnosed as postoperative infection.As a symptom of this bone cement loosening were observed.
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Manufacturer Narrative
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Corrected information: (report source) literature citation: daisuke togawa " complications and revision surgery of minimally invasive spinal surgery complications and strategy of balloon kyphoplasty ".A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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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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