Catalog Number 9734715 |
Device Problems
Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Patient age not available from the site.Device udi not provided.Device lot number, or serial number, unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.No parts have been received by the manufacturer for evaluation.Part lost by customer.
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Event Description
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Medtronic received information regarding a navigation device being used for a spinal fusion procedure.It was reported that during a case a surgeon had a difficult time removing the spine clamp.There was no reported impact on patient outcome.There was a reported delay to the procedure of less than 1 hour due to this issue.
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Manufacturer Narrative
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Additional information: medtronic received information that the surgeon continued with the procedure by utilizing microscope visualization and navigation on known anatomical methods.Patient date of birth provided.
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Manufacturer Narrative
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The fda codes were updated to reflect current coding guidelines.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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