No patient information provided as no patient was involved in this concern.Device lot number not available.Device manufacturing date is dependent on lot number, therefore, unavailable.The site did not request replacements, nor will they return their nav 4.5mm cannulated taps to manufacturer for analysis.Mechanical/instrument engineering analysis reports "the cannulated spine taps are intended to be used in mis (minimally-invasive surgery) procedures using a guidewire.If cannulated taps are used without a guide wire, bone will accumulate in the cannula and the device will be considered at the end of its useful life.The cannulated tap should be disposed according to national regulations." no further issues have been reported.
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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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