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Catalog Number C01B |
Device Problem
Leak/Splash (1354)
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Patient Problem
Numbness (2415)
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Event Date 04/08/2019 |
Event Type
Injury
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Manufacturer Narrative
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X-ray image review results: single lateral image of t6 kyphoplasty shows extravasation of cement from the posterior aspect of the vertebral body.By report, it is midline into the spinal canal.There is a substantial height loss of the vertebrae.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the patient underwent kyphoplasty at t6 due to vertebral compression fracture.Intra-op, during cement injection into the vertebral body, cement was noticed to be leaking from the posterior side into spinal canal.When the issue was noticed, the physician stopped the use of cement immediately.Post-op, the patient experienced numbness in feet as a result of this event.Cement was mixed for about 3 minutes and it was doughy and homogeneous prior to delivery into the patient.
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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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