CD HORIZON® SOLERA® VOYAGER¿ 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

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