RELINE

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.

Description of Event or Problem

IT WAS REPORTED THAT THE UNI SCREW THREADS SHEARED OFF AND WE WERE NOT ABLE TO FINAL TIGHTEN. WE USED THE RELINE PEDS TOWERS ALONG WITH THE PILE DRIVERS FOR REDUCTION. TWO SCREWS WERE AT THE TOP OF THE CONSTRUCT, AND ONE WAS IN THE MIDDLE. REMOVED ROD AND REPLACED SCREWS.