510k: this report is for an unknown femoral recon nail (frn) screw/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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It was reported that on an unknown date, the patient underwent an antegrade intramedullary procedure for a highly comminuted right subtrochanteric femur fracture with an associated injury which includes peripancreatic hematoma, bladder injury, l2 fractures, vascular injury of left external iliac, fractures of left ilium, sacrum, right ischium, and proximal femur.Other complications reported was osteomyelitis.There was no known delayed union of fracture.Patient outcome is unknown.No further information is available.This report is for an unknown femoral recon nail (frn) screw.This is report 2 of 2 for (b)(4).
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