CD HORIZON® FENESTRATED SCREW SET

Additional Manufacturer Narrative

G2: COUNTRY OF EVENT - UNITED ARAB EMIRATES. H3. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA DISTRIBUTOR REGARDING A PATIENT UNDERGOING SPINAL THERAPY. IT WAS REPO RTED THAT THE CEMENT LEAKED AFTER INJECTING INSIDE THE SCREW HEAD. THEY WERE USING THE VOYAGER FENESTRATED SCREW SYSTEM ALONG WITH THE BONE FILLER DEVICE (REF 6550102). OUT OF THE 8 SCREWS USED, ONE OF THEM SHOWED CEMENT LEAKAGE FROM THE TOP OF THE SCREW HEAD, THE REST OF THE SCREWS PERFORMED NORMALLY. THIS PREVENTED THE SET SCREW TO LIE DOWN PROPERLY, AND THE SURGEON HAD TO SPEND EXTRA TIME CLEARING OUT THE HARDENED CEMENT FROM THE SCREW HEAD BEFORE PUTTING THE SET SCREW AND PROCEEDING WITH THE ROD INSERTION. THERE WAS NO VISIBLE DAMAGE, STRIPPING, OR DEFECT IN THE SCREW OR BONE FILLER DEVICE. THE ISSUE SEEMED MORE LIKE BACKFLOW OR LOSS OF SEAL DURING CEMENT INJECTION. PRE-OP DIAGNOSIS: SEVER OSTEOPOROTIC PATIENT NEEDS POSTERIOR LUMBAR SPINE FIXATION. NO PATIENT COMPLICATIONS OCCURRED BECAUSE OF THIS INCIDENT. THE SURGERY WAS COMPLETED WITHOUT FURTHER ISSUES, AND THE PATIENT OUTCOME WAS STABLE. THERE WERE NO SIGNS OF ANY MANUFACTURING ISSUE OR PACKAGING PROBLEM WHEN THE PRODUCT WAS FIRST OPENED. EVERYTHING APPEARED NORMAL AND WAS PREPARED AS PER PROTOCOL. THE "PRODUCT STATUS" OF VOYAGER FENESTRATED SCREW (55850026545) IS ALREADY IMPLANTED INSIDE THE PATIENT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.