EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 X 7 X 50MM

Description of Event or Problem

DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2020, THE PATIENT UNDERWENT REVISION SPINAL SURGERY TREATING L4-S1. THE SURGEON EXPERIENCE DIFFICULTY REMOVED THE S1 SCREW AS THE DRIVER WAS UNABLE TO EFFECTIVE ENGAGE WITH THE SCREW. THE SCREW WAS FOUND THE BE STRIPPED AND WORN DOWN. THE SCREW HEAD WAS EVENTUALLY MOBILIZED AND ENABLED REMOVAL OF THE SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS RELATED TO (B)(4). THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 X 7 X 50MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

Additional Manufacturer Narrative

ADDITIONAL PROCODE: NKB, KWP, MNH, MNI, KWQ. INVESTIGATION SUMMARY VISUAL INSPECTION: THE EXP DI FAR SCREWS 7.00 X 50 (P/N:179799750, LOT NUMBER: ATMC4V) WAS RECEIVED AT US CQ. UPON VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED SCREW HEAD SEVERELY STRIPPED/WORN OUT. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST-MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE COMPLAINT DEVICE WAS RECEIVED WITH SEVERELY STRIPPED/ WORN OUT HEAD. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT, PART NUMBER: (B)(4), LOT NUMBER: (B)(4), SUPPLIER: MEDOS, BATCH# 1: RELEASE TO WAREHOUSE DATE: NOV 11, 2015, NO NCR'S WERE GENERATED DURING PRODUCTION. 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.