Identifying information, such as the part number and lot number of the device was not reported to paragon 28.Case information including facility, surgery date(s), or related patient information was not provided by the initial reporter.Reasonable efforts were made to obtain case information however, the reporter was not responsive.Devices are not expected to be returned for the manufacturer review/investigation.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.
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It was reported that the patient underwent a surgical procedure that utilized paragon 28 phantom small bone intramedullary nail system.The lapidus nail was reported broken post-operatively.The surgeon's post-operative protocol was reported as 2 weeks non-weight bare, 2 weeks touch weight , 2 weeks partial weight and then 6 weeks full weight bare.Two broken nails was reported.This report addresses the first nail reported broken.
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