6.5MM REVERE PEDICLE SCREW 35MM

Description of Event or Problem

IT WAS REPORTED TO GLOBUS THAT PATIENT REQUIRED REVISION SURGERY TO REMOVE BROKEN REVERE PEDICLE SCREW IN S1. INITIAL IMPLANT SURGERY TOOK PLACE ON (B)(6) 2013 WITH SUPPORT AT L4-S1. THE REVISION SURGERY TOOK PLACE (B)(6) 2013 TO REMOVE THE BROKEN S1 SCREW.

Additional Manufacturer Narrative

A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE PRODUCT WAS RETURNED FOR EVALUATION AND A REVIEW WAS CONDUCTED OF ALL APPLICABLE MATERIAL RECORDS, MANUFACTURING RECORDS, STORAGE RECORDS, AND DISTRIBUTION RECORDS ACCORDING TO THE DESCRIPTIONS OF THE PRODUCT USED WITH THE CONCOMITANT DEVICE. ALL RECORDS REVEALED ALL PRODUCT LOTS WERE MANUFACTURED WITHIN SPECIFICATIONS, MAINTAINED AND DISTRIBUTED IN ACCORDANCE WITH ALL FEDERAL, STATE AND OPERATING PROCEDURES. THE RETURNED PART WAS EVALUATED, ALL APPLICABLE DIMENSIONS AND MATERIAL COMPOSITION WERE MEASURED. THESE WERE DETERMINED TO BE WITHIN PRINT SPECIFICATIONS. THE BOTTOM PART OF THE SCREW COULD NOT BE REMOVED BY SURGEON, AND WAS LEFT IN THE PATIENT AT S1. THERE WERE NO NOTICEABLE SIGNS OF MANUFACTURING DEFECTS. THE BREAK OCCURRED 2 THREADS BELOW THE NECK OF THE SCREW. THE SCREW MAY HAVE FAILED DUE TO NON-UNION, OR EXCESSIVE FORCE OR TRAUMA SUCH AS A FALL OR INAPPROPRIATE ACTIVITY DURING RECOVERY. WE ARE UNABLE TO DETERMINE THE EXACT CAUSE OF THE BREAKAGE.