Catalog Number 9734403 |
Device Problems
Bent (1059); Material Deformation (2976)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/06/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information not provided due to japanese patient privacy regulations.Device lot number, or serial number, unavailable at the time of filing.Device manufacture date is not available at time of filing.No parts have been returned to the manufacturer for analysis.
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Event Description
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Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure.It was reported that the lumbar probe was deformed.There was no delay in surgery and no impact on patient outcome.
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Manufacturer Narrative
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Additional information: device lot number and manufacture date provided.
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Manufacturer Narrative
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The lumber probe was returned to the manufacturer for evaluation.After functional testing and visual/physical examination the reported issue was confirmed.The tip of the returned probe was bent and there were impact marks at the back causing fit issues with the mating tracker.Physical damage was found.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure.It was reported that the lumbar probe was deformed.There was no delay in surgery and no impact on patient outcome.
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Search Alerts/Recalls
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