CD HORIZON® SPINAL SYSTEM

Description of Event or Problem

INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A SCREW USED ON PATIENT HAVING PERCUTANEOUS PEDICLE SCREW FIXATION OF THE LUMBAR SPINE FOR L2 VERTEBRAL BODY FRACTURE (TYPE B2), MULTIPLE TRAUMA DUE TO A TRAFFIC ACCIDENT. IT WAS REPORTED THAT, DURING SURGERY, THE MULTI AXIAL SCREW AND SET SCREW WERE USED IN ACCORDANCE WITH THE RECOMMENDED PROCEDURE, BUT THE INNER LOCKING SCREW COULD NOT BE PROPERLY ENGAGED AFTER THREE INSERTION ATTEMPTS. UPON REMOVAL, DAMAGED (STRIPPED) THREADS AT THE SCREW HEAD WERE IDENTIFIED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

Additional Manufacturer Narrative

MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.