inforMED
MalfunctionHAX

HIFIX SKULL PIN

Received Dec 27, 2005

Report 1526439-2005-00279 · MDR key 656867

Device

Generic name

Component, Traction, Invasive

Manufacturer

Depuy Spine, Inc.

Model number

NA

Catalog number

AC020

Lot number

UNK

Product problems

  • Improper or Incorrect Procedure or Method

Patient

UNKNOWN

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

Narrative

Description of Event or Problem

DURING APPLICATION OF A HALO CROWN AND JACKET ON A PT, IT WAS NOTICED THAT ONE OF THE HIFIX HALO PINS HAD MANAGED TO PENETRATE THROUGH THE PATIENT'S SKULL WITHOUT THE TORQUE CAP BREAKING AS INTENDED.