inforMED
MalfunctionGZT

CASPAR VERTEBRAL BODY DISTR.

Received Oct 2, 2002 · Event occurred Sep 26, 2002

Report 2916714-2002-00020 · MDR key 420736

Device

Generic name

Retractor

Model number

NA

Catalog number

FF901R

Lot number

NA

Product problems

  • Component(s), broken

Patient

NO INFO

  • Surgery, prolonged

Narrative

Description of Event or Problem

INSTRUMENT WAS USED ON CERVICAL DISK AND BROKE WHILE IN THE PATIENT'S NECK. THE STATIONARY ARM BROKE OFF. SURGERY WAS EXTENDED APPROXIMATELY TEN MINUTES. THE PATIENT SUFFERED NO ADVERSE EFFECTS.