InjuryHTY
HAMMERTUBE¿ SYSTEM
Received Mar 29, 2025 · Event occurred Feb 6, 2025
Report 3008650117-2025-00000 · MDR key 21727619
Device
Generic name
Hammertube System Peek Implant, Ø2.75mm X 14mm, 10°, Sterile
Manufacturer
Paragon 28, IncModel number
P40-002-0275-SCatalog number
P40-002-0275-S
Lot number
26013172303
Product problems
- Migration
- Migration
Patient
NA · Female
- Inadequate Osseointegration
- Inadequate Osseointegration
Narrative
Description of Event or Problem
6 WEEKS POST-OPERATION THE PATIENT'S DISTAL FRAGMENT CAME LOOSE FROM THE HAMMERTUBE IMPLANT WITH NO FRACTURE OF EITHER THE BONE OR IMPLANT. THE HAMMERTUBE WAS REMOVED AND REPLACED WITH A HEADLESS SCREW.
Additional Manufacturer Narrative
H6. G - THIS EVENT DOES NOT INVOLVE A COMPONENT OF THE MEDICAL DEVICE BUT IT WAS MANDATORY I COMPLETE THIS FIELD TO FILE THE REPORT.
Additional Manufacturer Narrative
ADDED UDI TO D4.