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 10/12/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.
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Event Description
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It was reported that on (b)(6) 2016, patient underwent balloon kyphoplasty at t12 for a 4 months old compression fracture.Intra-op, the balloon ruptured during the first insertion attempt into the vertebral body.It could have been a result of a bone fragment that pierced the balloon but it was a high pressure balloon.The procedure completed successfully with the original product.The product came in contact with the patient.No patient complications were reported.
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Manufacturer Narrative
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Product analysis: visual and optical examination of the ibt balloon identified a radial sharp cut perpendicular to the ibt shaft 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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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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