CD HORIZON® BALLAST¿ SPINAL SYSTEM

Description of Event or Problem

INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING REMOVAL OF IMPLANT USED FOR POSTERIOR FIXATION FOR PELVIC FRACTURE. IT WAS REPORTED THAT THE CORE OFTHE ILIAC SCREW COULD NOT BE GRASPED, AND AFTER THE PHYSICIAN WAS INFORMED THAT THIS WAS NOT THE PROPER METHOD OF USE, REMOVAL WAS ATTEMPTED WITH THE FAS/SAS DRIVER. AT THAT TIME, THE HEAD WAS DAMAGED. AFTER THAT, THE CORE COULD BE GRASPED WITH THE BALLAST DRIVER, AND REMOVAL WAS PERFORMED. THERE WERE NO PATIENT SYMPTOMS 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.