MalfunctionHTT
5.0MM 12 FLUTE BARREL BUR, - HOLLOW, FORMULA (5BX)
Received Apr 27, 2009 · Event occurred Mar 16, 2009
Report 2648666-2009-00072 · MDR key 1431790
Device
Product problems
- Metal Shedding Debris
Patient
UNK
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGEON NOTICED THAT METAL PARTS WERE SHAVING FROM THE BUR. ALLEGEDLY, IT WAS NOT POSSIBLE TO REMOVE THE LITTLE METAL PIECES.
Additional Manufacturer Narrative
ADD'L INFO WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.