MalfunctionDZJ
ACCUPLAN
Received Mar 5, 2026 · Event occurred Feb 3, 2026
Report 3009196021-2026-00004 · MDR key 24519487
Device
Generic name
Titanium Surical Guide
Manufacturer
MedcadModel number
MC-KT011, MC-KT021Catalog number
MC-KT011, MC-KT021
Lot number
252547BRO
Product problems
- Patient-Device Incompatibility
- Positioning Problem
Patient
70 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SURGEON PERFORMED AN ADDITIONAL SURGERY WITHOUT USING THE GUIDES, NEXT DAY OF INTIAL SURGERY.
Description of Event or Problem
GUIDES DID NOT FIT DURING THE SURGICAL PROCEDURE, REVISION SURGERY REQUIRED.