inforMED
MalfunctionHTT

5.5MM 12 FLUTE ROUND BUR-HOLLOW (5BX)

Received May 7, 2008 · Event occurred Apr 8, 2008

Report 2648666-2008-00059 · MDR key 1046134

Device

Generic name

Bur

Catalog number

0275950012

Lot number

08044CG2

Product problems

  • Metal Shedding Debris

Patient

UNK

  • Unknown (for use when the patient's condition is not known)

Narrative

Additional Manufacturer Narrative

ADD'L INFO WILL BE PROVIDED ONE INVESTIGATION IS COMPLETED.

Description of Event or Problem

IT WAS REPORTED THAT DURING A PROCEDURE SURGEON STATED THAT METAL PIECES WERE COMING OFF ROUND BUR HOLLOW 12 FLUTE.