InjuryNKB
MESA RAIL DEFORMITY CONTOURED SIZE 495 MM, COCR
Received Jun 24, 2026 · Event occurred May 26, 2026
Report 3004774118-2026-00162 · MDR key 25616570
Device
Generic name
Thoracolumbosacral Pedicle Screw System
Manufacturer
K2m, Inc.Catalog number
811-H655495
Lot number
PPGB-529158
Product problems
- Biocompatibility
Patient
17 YR · Female
- Unspecified Infection
Narrative
Description of Event or Problem
A HEALTH PROFESSIONAL REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY 1 YEAR AND 2 MONTHS POST-OPERATIVELY TO ADDRESS AN INFECTION. IT WAS FURTHER REPORTED THAT EXUDATE WAS OBSERVED FROM THE SURGICAL SITE AND THAT THE IMPLANTS WERE REMOVED DURING THE REVISION SURGERY. THIS REPORT CAPTURES THE MESA CONTOURED DEFORMITY RAIL.