Identifying information, 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.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.
|
It was reported that the patient underwent a surgical procedure on (b)(6) 2017 that utilized a paragon 28 phantom intramedullary nail.The lapidus nail was reported fractured post-operatively with delayed union through the distal screw hole in the medial cuneiform.It was reported that the surgeon's post operative protocol for lapidus was followed.At about 8 weeks post-operatively, the patient was non-weight bearing for 6 weeks, then weight bearing as tolerated in boot for 1 week, then transitioned to a shoe 7 weeks after surgery.It was reported that the patient experienced increased pain, swelling and clicking at 8 weeks.The ct scan showed 30% fusion of superiormedial portion of arthrodesis site.The nail is not expected to be returned and a revision surgery was not reported.
|