CD HORIZON® FENESTRATED SCREW SET

Additional Manufacturer Narrative

H3: PRODUCT ANALYSIS OF PRODUCT:55751024535, LOT:H5842820 VISUAL EXAMINATION REVEALED THE SCREW WAS BROKEN ABOUT 10 THREADS DOWN FROM THE BASE OF THE BONE SCREW HEAD. OPTICAL EXAMINATION OF THE AREA OF FRACTURE INITIATION DID NOT IDENTIFY A PRE-EXISTING SURFACE DEFECTS THAT COULD CONTRIBUTE TO THE FRACTURE. THE DAMAGE TO THE SCREW APPEARS TO BE FROM OVERLOAD AS THE MECHANISM OF FAILURE. 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 REMOVAL OF SCREWS OR NAIL AT L3 THERAPY FOR RUPTURED FRACTURE. IT WAS REPORTED THAT A FRACTURE OCCURRED APPROXIMATELY 10 MM FROM THE TIP OF THE SCREW SHANK. THE FRACTURED PORTION REMAINED INSIDE THE VERTEBRAL BODY AND WAS NOT EXTRACTED, CONCLUDING THE PROCEDURE. THE PRODUCT WAS USED CORRECTLY, BUT THE IMPLANT WAS DAMAGED, LEAVING DEBRIS IN THE PATIENT¿S BODY. DESPITE THIS, THE PATIENT RECOVERED FULLY WITH NO COMPLICATIONS OR HEALTH DAMAGE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

Additional Manufacturer Narrative

E1: FIRST NAME AND LAST NAME OF INITIAL REPORTER IS UNKNOWN. G2: THE COUNTRY OF THE EVENT IS JAPAN. 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.