inforMED
MalfunctionHOA

BA-320-185

Received Sep 8, 2014 · Event occurred Aug 7, 2014

Report 3005726841-2014-00008 · MDR key 4095491

Device

Generic name

Bone Anchor

Manufacturer

Biotex, Inc.

Lot number

142045

Product problems

  • Break
  • Material Fragmentation
  • Material Integrity Problem

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

DURING REMOVAL OF BONE ANCHOR, IT WAS DISCOVERED THE LAST FEW THREADS WERE BROKE OFF THE BONE ANCHOR. THE SURGEON RECOVERED THE THREADS. PT WAS CLOSED WITH SUTURE AS USUAL.