DEVICE ONE: CERVICAL INSTRUMENT CHISEL, 7MM

Description of Event or Problem

IT WAS REPORTED TO GLOBUS BY A SALES REP THAT DURING A SURGERY, UPON IMPACTION OF THE BROACHING CHISEL (7MM) OVER A 7MM TRIAL (14 X 16 MM, 6 DEGREES) THE INSTRUMENTS WERE PUSHED TOO FAR POSTERIOR INTO THE SPINAL CANAL. THE INSTRUMENTS MADE CONTACT WITH THE SPINAL CORD AND RESULTED IN WHAT APPEARS TO BE A SPINAL CORD INJURY. A TWO LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION WAS PERFORMED WITH A CERVICAL PLATE AND INTERBODY SPACERS TO FUSE THE SEGMENTS OF THE SPINE, C5 - C7. THIS PROCEDURE WAS PERFORMED IN LIEU OF THE ORIGINALLY PLANNED SURGERY. ORIGINAL PLANNED SURGERY WAS GOING TO BE A 1 LEVEL CERVICAL FUSION C6 - C7, AND A 1 LEVEL DISC REPLACEMENT C5 - C6.

Additional Manufacturer Narrative

A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE PRODUCT WAS NOT RETURNED FOR EVAL; HOWEVER, A REVIEW WAS CONDUCTED OF ALL APPLICABLE MATERIAL RECORDS, MANUFACTURING RECORDS, STORAGE RECORDS, AND DISTRIBUTION RECORDS ACCORDING TO THE DESCRIPTION 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. THERE WAS NO FAILURE OF INSTRUMENTATION REPORTED. INSTRUMENT IS NOT AVAILABLE FOR EVAL. THERE HAVE BEEN NO PREVIOUS COMPLAINTS ON THIS INSTRUMENT.