The site declined to provide patient information, per (b)(4) privacy laws.Device lot number not available.Device manufacturing date is dependent on lot number, therefore, unavailable.No parts have been received by manufacturer for analysis.No further issues have been reported.Part not received by manufacturer.
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A medtronic representative reported that, while in a spine procedure, the surgeon used the 2.25 millimeter pedical probe on sacral region.While using the probe, the tip bent.The surgeon opted to continue and completed the procedure with the use of the navigation system.There was no delay of therapy.There was no impact on patient outcome.
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