MalfunctionKWO
ASTURA MEDICAL
Received Oct 15, 2025 · Event occurred Nov 18, 2024
Report 3015941638-2025-00011 · MDR key 23295465
Device
Generic name
Acp, 1 Level, 14mm
Manufacturer
Astura MedicalModel number
CA1000014Catalog number
CA1000014
Lot number
765801F
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
52 YR · Male
- Implant Pain
- Implant Pain
Narrative
Description of Event or Problem
SCREW BACKED OUT OF PLATE REQUIRING A REVISION SURGERY. ASTURA WAS NOT NOTIFIED OF THIS UNTIL (B)(6) 2025.
Additional Manufacturer Narrative
PERFORMANCE TESTING OF THE IMPLANTS SHOW THEY MEET OUR ESTABLISHED PERFORMANCE REQUIREMENTS.
Remedial action
- Inspection