inforMED
InjuryNKB

MESA 2 DEFORMITY UNIPLANAR SCREW SIZE Ø5.0X30 MM

Received Jun 25, 2026 · Event occurred May 26, 2026

Report 3004774118-2026-00175 · MDR key 25619338

Device

Generic name

Thoracolumbosacral Pedicle Screw System

Manufacturer

K2m, Inc.

Catalog number

6201-35030

Lot number

XPHV-593709

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 ELEVENTH OF FOURTEEN MESA 2 DEFORMITY UNIPLANAR SCREWS.