MalfunctionPGM
MARVEL
Received Apr 3, 2026 · Event occurred Mar 17, 2026
Report 3004142400-2026-00069 · MDR key 24778015
Device
Generic name
Bone-screw Internal Spinal Fixation System, Sterile
Manufacturer
Globus Medical, Inc.Model number
5214.0040SProduct problems
- Fracture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS UNAVAILABLE FOR EVALUATION. NO DETERMINATIONS COULD BE MADE AS TO THE CAUSE OF THE REPORTED ISSUE.
Description of Event or Problem
IT WAS REPORTED THAT FOUR WEEKS AFTER DISTRACTION A ROD FRACTURE WAS FOUND.