InjuryHSB
EBA2
Received Jun 11, 2015
Report 3003249380-2015-00001 · MDR key 4848083
Device
Generic name
Proximal Femoral Nail Cephalic Screw
Manufacturer
Citieffe SrlProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Nonunion/Delayed-union Bone Fracture
Narrative
Additional Manufacturer Narrative
THE IMPLANT WAS USED FOR A VERY DIFFICULT FRACTURE PATTERN THAT WAS NOT APPARENT AT THE INITIAL START OF SURGERY. THE LOADING ON THE IMPLANT DUE TO THE FRACTURE PATTERN EXCEED THE NORMAL LOAD CAPABILITY OF THE IMPLANT.
Description of Event or Problem
REF IMP #(B)(4).