Catalog Number 9734436 |
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 12/02/2014 |
Event Type
malfunction
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Event Description
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A medtronic representative reported that during a spinal fusion procedure the tactile probe was bent.The surgeon had applied significant force to the the tactile probe while at depth in the pedicle.The surgeon opted to use a different probe for the remainder of the surgery.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.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 analysis.
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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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