inforMED
InjuryEZX

UNKNOWN

Received Apr 13, 2010 · Event occurred Mar 15, 2010

Report 3005751028-2010-00017 · MDR key 1662708

Device

Generic name

Unknown

Model number

NA

Catalog number

UNK

Lot number

UNK

Product problems

  • Insufficient Device Problem Information

Patient

Not reported

  • No Code Available

Narrative

Additional Manufacturer Narrative

INVESTIGATION IN PROCESS.

Description of Event or Problem

EVENT DETAIL: IT WAS REPORTED THAT THE PATIENT WAS REVISED. THE DEVICE WAS IMPLANTED FOR APPROXIMATELY 6 MONTHS. THE ORIGINAL PROCEDURE WAS A STAND ALONE TWO LEVEL ACDF. PRECEDING OR CONTRIBUTING EVENTS: THE PATIENT WAS A SMOKER, EXCESSIVE DRINKER AND POTENTIALLY NON-COMPLIANT.