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Catalog Number C01A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Neurological Deficit/Dysfunction (1982); Collapse (2416)
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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.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 for this procedure: primary osteoporosis type of fracture: compression fracture levels implanted: t11-l5 it was reported that the patient underwent a kyphoplasty at l1, l3.Post-op, collapse occurred at l1 and patient experienced neurological symptoms due to osteophyte invagination into the spinal canal.Hence, posterior fusion was performed as a result of the event.
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Search Alerts/Recalls
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