MIS TI CFX FEN POLY 7X40
Received Apr 23, 2026 · Event occurred Apr 1, 2026
Report 1526439-2026-00458 · MDR key 24968782
Device
Generic name
Bone Cement, Posterior Screw Augmentation
Manufacturer
Depuy Spine IncCatalog number
186727740
Lot number
386048
Product problems
- Migration
Patient
Not reported
- Pain
Narrative
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
Description of Event or Problem
INSITU INNIE RELAXATION REVIEW OF THE INNIES. THREE MONTHS POSTOPERATIVELY, THERE WAS A SUDDEN ONSET OF LUMBALGIA WITH PAIN RADIATION IN THE LEFT LEG. THESE PAINS PERSISTED. A REVISION OPERATION WAS CARRIED OUT. THE LOCKING NUT WAS DETACHED FROM THE SCREW.