InjuryNKB
MESA 2 DEFORMITY UNIPLANAR SCREW
Received Jun 25, 2026 · Event occurred May 26, 2026
Report 3004774118-2026-00174 · MDR key 25619234
Device
Generic name
Thoracolumbosacral Pedicle Screw System
Manufacturer
K2m, Inc.Catalog number
6201-35535
Lot number
XYBD-524468
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 FIFTH OF FOURTEEN MESA 2 DEFORMITY UNIPLANAR SCREWS.