EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORT FIX POLYAXIAL SCREW 5.5 6.0 X 45MM

Additional Manufacturer Narrative

DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. D2: ADDITIONAL PROCODE: MNI. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E3: INITIAL REPORTER IS A SYNTHES EMPLOYEE. H3, H4, H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: ADJACENT SEGMENT PATHOLOGY, INSTABILITY, NEUROCOMPRESSION, SPINAL IMBALANCE. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT IS FOR AN EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 6.0 X 45MM. THIS IS REPORT 3 OF 4 FOR (B)(4).