T2 STRATOSPHERE EXPANDABLE CORPECTOMY SYSTEM

Additional Manufacturer Narrative

H3: PRODUCT ANALYSIS: 436120C, LOT# CA19L057 VISUAL AND OPTICAL INSPECTION REVEALED THE TEETH AND THE CAGE OF THE CENTERPIECE HAVE BEEN DAMAGED/DEFORMED. FUNCTIONAL TEST WITH A SAMPLE INSERTER CONFIRMED THE CENTERPIECE WOULD NOT OPEN. THE DAMAGE APPEARS TO BE WHERE THE TIP OF THE EXPANSION SHAFT CONTACTS THE TEETH AND CAGE OF THE CENTERPIECE WHEN THE EXPANSION SHAFT IS INSERTED AND TURNED. THE LOCKING SET SCREW BACKED OUT, THE ASSEMBLY MUST BE ABLE TO SMOOTHLY EXPAND AND COLLAPSE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT THAT OCCURRED DURING OLIF PROCEDURE ON L4/5 AND VERTEBRAL BODY REPLACEMENT (FORWARD APPROACH) ON L3 IN A PATIENT DIAGNOSED WITH L3 RUPTURE FRACTURE AND SPINAL STENOSIS. IT WAS REPORTED THAT BOTH THE CAGES WERE NOT EXPANDING PROPERLY AND THE SWINGING PART OF THE CAME OFF AND BROKE. CAGES WERE IMPLANTED IN THE PATIENT AND WILL NOT BE RETURNED AND PRODUCT RETURN FOR THE INSERTER WAS REQUESTED. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED.