KYPHON KIS

Additional Manufacturer Narrative

D4: THE SPECIFIC LOT NUMBER OF IBT ASSOCIATED WITH THE REPORTED RUPTURE COULD NOT BE CONCLUSIVELY IDENTIFIED BASED ON THE AVAILABLE INFORMATION. THEREFORE, BOTH POTENTIAL LOT NUMBERS (232334176 AND 232222803) ARE BEING PROVIDED FOR REFERENCE. 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 WHO UNDERWENT TREATMENT AT T12 FOR A COMPRESSION FRACTURE ASSOCIATED WITH PRIMARY OSTEOPOROSIS. IT WAS REPORTEDTHAT DURING THE PROCEDURE, BALLOON EXPANSION WAS PERFORMED AND CEMENT WAS MIXED; WHEN THE CEMENT REACHED THE INTENDED HARDNESS, AN ATTEMPT WAS MADE TO DEFLATE THE IBT, AT WHICH TIME PRESSURE WAS NOTED TO BE ZERO AND THE BALLOON WAS IDENTIFIED AS RUPTURED. IRRIGATION AND ASPIRATION OF THE VERTEBRAL BODY WITH SALINE WERE PERFORMED, AND THE CEMENT HARDENED DURING THIS PROCESS. THE EVENT OCCURRED DURING THE INITIAL INSERTION/USE OF THE VERTEBRAL BODY BALLOON AND RESULTED IN A PROCEDURE DELAY OF LESS THAN 60 MINUTES.THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.