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Catalog Number 9734403 |
Device Problems
Bent (1059); Device Issue (2379)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/26/2014 |
Event Type
malfunction
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Event Description
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A medtronic representative reported that, while in a spinal procedure, the thoracic probe instrument was damaged.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 unavailable from the site.The initial report occurred on 02/26/2014 but was not reported to a medtronic representative until 07/24/2014.Device lot number, or serial number, not available as part has been discarded by the site.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.Replacement device shipped to site for issue resolution.No parts have been received by the manufacturer for analysis as the instrument has been discarded by the site.
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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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