MEDOS INTERNATIONAL SÃ RL CH HIGH VISC CMW SPINAL CMT, 11CC; CONFIDENCE CEMENT, BONE, VERTEBROPLASTY
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Catalog Number 183901001 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); Hypersensitivity/Allergic reaction (1907)
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Event Date 04/20/2018 |
Event Type
Death
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Manufacturer Narrative
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A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.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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Surgeon sent a letter and reported two ((b)(4)) aes with confidence cement: kyphoplasty because of osteoporotic sintering fracture without any complication while patient was in prone position.Immediately after introducing cement in three levels as per manufacturer´s instruction the patient showed a circulation reaction with hypotonia and oxygen disorder, so that procedure had to be stopped.Patient was reanimated.Ct angiography did not show any pulmonary embolism.Later in the course patient died.
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Search Alerts/Recalls
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