PRECICE® INTRAMEDULLARY LIMB LENGTHENING SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT HAD A LEFT FEMORAL LENGTHENING PROCEDURE WHERE 8 CM LENGTHENING WAS PLANNED VIA NUVASIVE PRECICE MAGNETIC NAIL WHICH WAS PLANNED. AFTER BRIEFLY GAPPING 5 MM, NAIL FAILED TO LENGTHEN AND DETERMINED TO BE DEVICE FAILURE. A REVISION SURGERY PERFORMED WITH NEW NAIL PLACED.

Additional Manufacturer Narrative

THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION.