STABILITY PIN RET BLADE

Description of Event or Problem

INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR LUMBAR INTERBODY FUSION THERAPY AT L5S1. IT WAS REPORTED THAT DURING THE PROCEDURE, DISCOVERED THAT A PIN OF THE ENDORING ANCILLARY DEVICE WAS STUCK IN THE VALVE. PRESENCE OF METAL PARTICLES NOTICED IN THE SURGICAL SITE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE PIN HAS BEEN BROKEN AND STUCK IN THE ENDORING VALVE.

Additional Manufacturer Narrative

H3: PRODUCT ANALYSIS OF PRODUCT:897-405, LOT:PZ21H002 VISUAL AND OPTICAL INSPECTION CONFIRMED THAT THE TIP OF THE STABILITY PIN HAS BEEN BENT DUE OVERLOAD. E1: FIRST NAME AND LAST NAME OF INITIAL REPORTER IS UNKNOWN. 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.