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Catalog Number C01A-J |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Neurological Deficit/Dysfunction (1982)
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Event Type
Injury
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Manufacturer Narrative
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This product is not approved for use in the us, however a like device with part# c01a, 510k# k041584 and upn (b)(4) is approved for the market.Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.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 balloon kyphoplasty (bkp) at th12 due to primary osteoporosis,compression fracture.After bkp operation was performed at th12, fusion was performed on the patient with screw at l1/2 and transverse hook at th12.After operation, the cement migrated to the ventral side.About half of the cement protruded.This was confirmed on (b)(6) 2018 in imaging.Reportedly, there was neurological symptom due to instability.There was no impact with blood vessel/macrovascular at present.Posterior fusion was planned to be performed later.
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Search Alerts/Recalls
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