LIGA PASS

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.

Description of Event or Problem

INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS SCOLIOSIS. IT WAS REPORTED THAT, 2 OF 7 LIGA PASS BANDS WERE BROKEN INTRA-OPERATIVELY ALTHOUGH THE INDICATOR ON THE TENSIONER WAS STILL WELL AWAY FROM THE 550N. IN BOTH CASES, THE BELTS WERE TORN OUT OF THE HOLES AT THE STARTING POINT, JUST BEHIND THE SCREW. THE PRODUCT WAS USED CORRECTLY AND COMPLETELY OPENED AND USED ACCORDING TO THE LABELLING. PRODUCT PREPARATION WAS CARRIED OUT EXACTLY AS IN THE BROCHURE. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO MALFUNCTION ASSOCIATED WITH THE CONNECTOR. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.