MalfunctionHOA
BA-320-185
Received Jul 23, 2014 · Event occurred Jun 20, 2014
Report 3005726841-2014-00006 · MDR key 4176259
Device
Generic name
Bone Anchor
Product problems
- Break
- Material Fragmentation
- Material Integrity Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A BONE ANCHOR WAS INSTALLED PRIOR TO MRI IN PREPARATION FOR LASER ABLATION PROCEDURE. IT WAS DETERMINED THAT THE PT STILL HAD ORTHODONTICS AND THESE HAD TO BE REMOVED PRIOR TO THE MRI/LASER ABLATION PROCEDURE. THE BONE ANCHOR WAS INADVERTENTLY BROKEN DURING THE PROCESS OF REMOVING THE PTS ORTHODONTICS PRIOR TO THE LASER ABLATION. THE LASER ABLATION PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE ENTRY SITE WAS CLOSED AT THE CONCLUSION OF THE PROCEDURE WITH A SMALL PORTION OF THE BONE ANCHOR THREAD LEFT IN PT'S BONE.