CD HORIZON¿ MODULEX¿ SPINAL SYSTEM

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.

Description of Event or Problem

INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION THERAPY. IT WAS REPORTED THAT, DURING AN IMPLANT PROCEDURE THE SET SCREW SPLINTERED A SMALL STRIP OF METAL AT THE BEGINNING OF TIGHTENING THE CAP. THE SET SCREW WAS IMPLANTED AND REMAINED IN SERVICE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND REVISION SURGERY SCHEDULED OR PLANNED FOR THE REMOVAL OF IMPLANT. THE SMALL SHAVINGS CAME OFF THE SET SCREWS WHEN PROPERLY PLACING FOLLOWING THE SURGICAL TECHNIQUE.