Identifying information of the part, such as the lot number of the device was not reported to paragon 28.Devices are not expected to be returned for the manufacturer review/investigation.The review of the device history records of the k-wire used during the surgery indicate that the device was manufactured according to specification and no deviations were noted for released product.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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