CD HORIZON® FENESTRATED SCREW SPINAL SYSTEM

Description of Event or Problem

INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR LUMBAR SPINAL CANAL STENOSIS AND THERE WAS A LESS THAN 60 MINUTES DELAY IN OVERALL DELAY IN THE PROCEDURE TIME. IT WAS REPORTED THAT AFTER L4/5 OBLIQUE LATERAL INTERBODY FUSION (OLIF) AND L4/5/S1 FIXATION, DISLODGEMENT OF THE RIGHT L4 SET SCREW AND LOOSENING OF THE SCREW OCCURRED, AS A RESULT REOPERATION WAS REQUIRED, ADJACENT SEGMENT DISEASE ALSO DEVELOPED AT L3/4, AND FIXATION WAS EXTENDED WITH REPLACEMENT OF THE L4 SCREW. ON THE SIDE WHERE THE SET SCREW HAD DISLODGED, WHEN ATTEMPTING TO ENGAGE THE DRIVER TO REMOVE THE SCREW, CEMENT HAD LEAKED INTO THE TORX RECESS, PREVENTING ENGAGEMENT OF THE DRIVER. BY REMOVING THE LEAKED CEMENT USING NUCLEUS PULPOSUS FORCEPS OR SIMILAR INSTRUMENTS, THE DRIVER WAS ABLE TO BE ENGAGED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED AS THERE WERE NO ISSUES OR COMPLAINTS REGARDING THE CEMENT. ADDITIONAL INFORMATION WAS RECEIVED AS THERE'S NO MALFUNCTION/ALLEGATION WITH THE ROD, AND THE SCREW WITH LOOSENING AT L4 ON THE LEFT SIDE WAS DISCARDED AND THE IMPLANT DATE IS UNKNOWN.

Additional Manufacturer Narrative

B2: OUTCOME ATTRIBUTED TO ADVERSE EVENT IS ADDITIONAL SURGERY DUE TO DEVICE MALFUNCTION. B3: EVENT DATE IS UNKNOWN D4: LOT NUMBER IS UNKNOWN G2: THE COUNTRY OF THE EVENT IS JAPAN H6: 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. 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.