CD HORIZON® SPINAL SYSTEM

Description of Event or Problem

INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR DEGENERATIVE DISC DISEASE, REVISION FUSION L5-S1. IT WAS REPORTED THAT ON FINAL TIGHTENING OF CONNECTOR THE SET SCREW STRIPPED. AN ATTEMPT WAS MADE TO REMOVE AND REPLACE THE SET SCREW, BUT IT COULD NOT BE REMOVED AND JUST TURNED IN PLACE. THE CONNECTOR BECAME LOOSE ON THE ROD AND WOULD NOT RELEASE. THE CONNECTOR AND SET SCREW WERE CUT WITH AN MR8 METAL CUTTER TO RELEASE AND REMOVE THEM, WHICH PROLONGED OPERATIVE TIME. THE CONNECTOR AND SET SCREW WERE REPLACED WITH NEW COMPONENTS AND THE CASE WAS COMPLETED. 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.