DISTRACTION CRANIOXPAND

Additional Manufacturer Narrative

AN INVESTIGATION WAS SUCCESSFULLY COMPLETED. THE RESULTS OF THE INVESTIGATION HAVE IDENTIFIED NO MANUFACTURING ISSUES, NO DESIGN ISSUES AND/OR CORRECTIVE ACTIONS NECESSARY AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED THAT MIGHT ADD VALUE TO THE CONTENTS OF THE INVESTIGATION REPORT, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

DURING DISTRACTION SURGEON OBSERVED THAT PATIENT ANATOMY LIFTED UP POSTERIORLY MORE THAN SURGEON HAD INTENDED. SURGEON ELECTED TO REMOVE DEVICE AND NOT REPLACE IT.