Catalog Number KE152 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/12/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Product analysis: visual and optical examination of the ibt balloon identified a sharp cut at the distal lobe of the balloon.The morphology, location and timing of the balloon rupture is consistent with in vivo contact with sharp object, such as bone splinters.A good faith effort will be made to obtain the applicable information relevant to the report.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 on (b)(6) 2016, patient underwent balloon kyphoplasty at l1 for vertebral compression fracture.Intra-op, during inflation, the ibt (inflatable bone tamp) ruptured.The ibt failed during the first insertion attempt into the vertebral body at 250 psi.The patient was not allergic to the contrast media.The procedure was completed with a new product.The product came in contact with the patient.No patient complications were reported.
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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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