inforMED
InjuryKGS

SDI

Received Mar 8, 1999 · Event occurred Apr 13, 1998

Report 1219161-1999-00191 · MDR key 213215

Device

Generic name

Unk

Model number

UNK

Catalog number

NA

Lot number

NA

Product problems

  • Explanted
  • Device Issue

Patient

UNKNOWN

  • Pain
  • Surgical procedure, repeated
  • Other (for use when an appropriate patient code cannot be identified)
  • Surgical procedure

Narrative

Description of Event or Problem

THE DEVICE WAS USED DURING A TFC FUSION CAGE EXPLANTATION. REPORTEDLY, THE CAGES WERE REMOVED DUE TO EXTREME PAIN AND PSEUDOARTHROSIS. THE HOSP HAS REPORTED THE PT'S CONDITION IS SATISFACTORY.