Catalog Number 08.702.017S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Reaction (2414)
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Event Date 12/03/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that the patient de-saturated shortly after a vertebroplasty in which vertecem ii was used.The oxygen saturation dropped shortly after the procedure was completed.Computerized axial tomography (ct scan) showed a small pulmonary embolus (pe), but nothing that would support the amount of desaturation that took place in the surgeon's opinion.The surgeon suspects a possible systemic reaction to the cement.Another surgery procedure for december 3, 2015 was cancelled due to the patient's reaction.The patient is now fully recovered and doing fine.This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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Only patient last initial known; no other patient information is known.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Additional narrative: updated patient information provided by reporter.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Update: (b)(6) 2016, it is also reported patient suffered lumbar scoliosis and flat back deformity.Surgery was cancelled at the time of event.Patient underwent unplanned ct scan of the chest as a result of this event.Patient was returned to surgery on (b)(6) 2015, causing a delay of 5 days.Surgeon reports patient suffered no long term sequelae as a result of this event.No further information is available.
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Search Alerts/Recalls
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