A medtronic representative reported that, while in a spine procedure, the site noted their 5.5/6.0 solera driver was damaged.No further details regarding the damage, or how it occurred, were provided.A second instrument tray was opened and a driver from that tray was used to move forward with navigation.There was no delay in the procedure.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.
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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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