MalfunctionHOA
BA-320-185
Received Aug 27, 2014 · Event occurred Jul 28, 2014
Report 3005726841-2014-00007 · MDR key 4102325
Device
Generic name
Bone Anchor
Manufacturer
Biotex MedicalProduct problems
- Break
- Material Fragmentation
- Material Integrity Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
FOLLOWING COMPLETION OF PROCEDURE, IT WAS DISCOVERED DURING ANCHOR BOLT REMOVAL THAT THE ANCHOR BOLT WAS BROKEN. THE BREAK WAS AT THE POINT OF ATTACHMENT OF THREADS. THE SURGEON OPTED TO LEAVE IN THE SMALL PLASTIC THREADS IN PLACE RATHER THAN REMOVE.