Catalog Number 55840008570 |
Device Problem
Break (1069)
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Patient Problems
Pain (1994); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Product was not 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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Pre-op diagnosis: degenerative spinal disease and previous t11-pelvis fusion ((b)(6) 2015) procedure: revision pelvis screws to previous t11-pelvis fusion levels implanted: t11-pelvis it was reported that post-op, distal component of broken screws were too deep in pelvis to be removed.Movement was visible during surgery at s1/pelvis junction.The patient suffered from pain and hence a revision for the pelvic screws was done.Fragments of the product remained in the patient as distal component of broken screws could not be removed because they were too deep in pelvis to be removed without additional trauma to patient.
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Manufacturer Narrative
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Image review: post-op images from t11 to iliac surgery shows fracture of the iliac and sacral screws bilaterally.There is a small l5-s1 interbody device with a paucity of bone graft at this level.The fracture of the iliac screw appears to be deep and difficult to remove, contributing factors include failure of fusion.Hardware placement and alignment appear satisfactory.Root cause: patient factors.
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Manufacturer Narrative
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Product analysis: visual examination of the mas bone screw confirmed bone screw complete fracture at approximately ~8-9 threads from the base of the bone screw head.Optical examination did not identify material defect near the area of fracture origin, which could contribute to crack propagation.Microscopic examination of the fracture surface identified gently curving convex striations through the cross sectional area of the implant, which are indicative of cyclic fatigue until subsequent mechanical failure of the implant.Dimensional inspection of major and minor diameter confirms conformance to print specification.After visual, optical and dimensional inspection, no evidence was found that would suggest a defect in manufacturing or processing of the implant components.The above observations are consistent with cyclic fatigue.
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Manufacturer Narrative
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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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Search Alerts/Recalls
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