inforMED
MalfunctionDZH

CORE INTRA-ORAL BLADE;OSCILLATING 7MM SAW BLADE

Received Jul 11, 2009 · Event occurred Jun 2, 2009

Report 1427149 · MDR key 1427149

Device

Generic name

Intra-oral Blade, Oscillating

Model number

NA

Catalog number

5400-31-32

Lot number

31309010825501780-08255017

Product problems

  • Break

Patient

19 YR

  • No Information

Narrative

Description of Event or Problem

DURING THE CASE AT TWO DIFFERENT TIMES WE HAD TO REPLACE OSCILLATING INTA-ORAL 7MM SAW BLADE BECAUSE IT BROKE WHILE THE SURGEONS WERE USING IT IN THE PATIENT'S MOUTH.