MEDTRONIC SOFAMOR DANEK USA, INC CAPSTONE SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
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Catalog Number 2990003 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/29/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Device was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.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 the patient underwent lumbar interbody fusion at l3/4/5 due to degenerative scoliosis.Intra-op, the cage was inserted from the left of l4/5, while being hammered, physician confirmed from the perspective image that the marker looked different from usual.When the physician attempted to adjust the marker to be reflected on the true sagittal, the inserter broke along with a snap sound.No fragment remains in the patient.No patient symptoms or complication were reported as result of this event.
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Manufacturer Narrative
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Product analysis result: visual and optical inspection of the inserter shaft did not reveal and cracks, surface scratches or any thread damage.Functional test confirmed the inserter was able thread into a sample implant and retain it.The instrument is capable of performing its intended function.No fault found.If information is provided in the future, a supplemental report will be issued.
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