CD HORIZON® FENESTRATED SCREW 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 WITH IMPLANTED SPINAL SCREWS. IT WAS REPORTED THAT ONE OF THE CAUDAL SCREWS HAD FRACTURED 2 MONTHS AFTER SURGERY. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT SUFFERED SEVER BACK PAIN (COMPARED TO BEFORE SURGERY). THE ISSUE WAS LEARNED AT AN OUTPATIENT EXAMINATION AFTER DISCHARGE, AND AT THE PRESENT TIME THERE HAS BEEN NO ADDITIONAL HOSPITALIZATION OR SURGERY. A REVISION SURGERY INCLUDING REMOVAL + EXTENSION + VERTEBRAL BODY REPLACEMENT IS SCHEDULED AT ANOTHER FACILITY ON (B)(6). IT WAS REPORTED THAT BONE FUSION DID NOT OCCUR AT THE TIME THE EVENT WAS REPORTED. THE PATIENT UNDERWENT 1A-1B FIXATION WITH PERCUTANEOUS PEDICLE SCREW. NO FURTHER COMPLICATIONS WERE REPORTED REGARDING THIS EVENT. ADDITIONAL INFORMATION RECEIVED STATED THAT REOPERATION WAS PERFORMED AT (B)(6) HOSPITAL. FIXATION WAS EXTENDED TO T11 AND L3/4, AND VERTEBRAL BODY REPLACEMENT WAS PERFORMED AT L1. THE FRACTURED SHANK WAS LEFT IN THE VERTEBRAL BODY, AND ONLY THE HEAD WAS RETRIEVED. NO FURTHER COMPLICATIONS WERE REPORTED REGARDING THIS EVENT.