VIPER
Received Jun 23, 2026 · Event occurred Jan 1, 2026
Report 1526439-2026-00895 · MDR key 25598300
Device
Generic name
Bone Cement, Posterior Screw Augmentation
Manufacturer
Medos International Sã rl ChCatalog number
186727650
Lot number
429241
Product problems
- Break
Patient
Not reported
- Insufficient Information
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
IT WAS REPORTED THAT MIS TI CFX FEN POLY 6X50 HAD BROKEN POSTOPERATIVELY, WITH TWO SCREWS FOUND SEPARATED INTO MULTIPLE PIECES IN SITU. AS A CONSEQUENCE, THE DORSAL INSTRUMENTATION WAS EXTENDED TO TH12, INDICATING A CORRECTIVE INVASIVE PROCEDURE WAS REQUIRED FOR DEVICE REVISION OR REPLACEMENT.