Catalog Number 9734402 |
Device Problems
Bent (1059); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/17/2014 |
Event Type
malfunction
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Event Description
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A medtronic representative reported that, while in a spine procedure, the site bent their lumbar probe.A second instrument was brought in to continue the procedure.No further details regarding the damage, or how it occurred, were provided.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.
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Manufacturer Narrative
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Patient information was not made available from the site.Device lot number, or serial number, not available.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.Return requested.Replacement lumbar probe tip shipped to site (b)(4) 2014.No parts have been returned to manufacturer for analysis.
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Manufacturer Narrative
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Patient information now provided.Patient weight not available from the site.Device lot number, or serial number now provided.Device manufacturing date now provided.
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Manufacturer Narrative
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Correction: on 13-oct-2015, it was noticed that a previous mdr submission contained incorrect information with regards to the common device name, product code and/or pma/510(k).This mdr is being submitted to correct this information.There is no new information to change the patient information, event description or manufacturer narrative that was previously reported.
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Search Alerts/Recalls
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