MalfunctionHTW

KLS TITANIUM SYSTEM

Received Aug 19, 2010 · Event occurred Jul 30, 2010

Report MW5017196 · MDR key 1813874

Device

Generic name

Drill Twist 1.5mm X 115mm

Manufacturer

Kls

Model number

25-872-09-1

Lot number

58544

Product problems

Break

Patient

14 YR

Device Embedded In Tissue or Plaque

Narrative

Description of Event or Problem

DISTAL TIP OF DRILL BIT BROKE OFF IN LEFT MANDIBLE AND LEFT IN MANDIBLE. DIAGNOSIS OR REASON FOR USE: ADVANCEMENT MANDIBULAR AND DORSAL NASAL RECONTOURING.