MalfunctionPLR
CORPECTOMY CAGE WITH SET SCREW; SIZE 12X14MM, 22-28MM, 0°, 0-20°
Received Feb 5, 2026 · Event occurred Jan 8, 2026
Report 3004774118-2026-00032 · MDR key 24273223
Device
Generic name
Spinal Vertebral Body Replacement Device - Cervical
Manufacturer
K2m, Inc.Catalog number
7512-21428L0-G3
Lot number
UNKNOWN
Product problems
- Mechanical Jam
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CORRECTED DATA: G1. H6 CODING HAS BEEN UPDATED TO REFLECT COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
NO NEW INFORMATION.
Description of Event or Problem
A COMPANY REPRESENTATIVE REPORTED THAT A CAPRI EXPANDABLE CORPECTOMY CAGE WITH SET SCREW WAS UNABLE TO EXPAND INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIVE-MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT.