inforMED
InjuryMTZ

OCU-GUARD

Received Nov 14, 2003

Report 2183620-2003-00039 · MDR key 495757

Device

Generic name

Orbital Implant Wrap

Model number

UNK

Catalog number

*

Lot number

UNK

Product problems

  • Explanted

Patient

UNKNOWN

  • Unspecified Infection
  • Surgical procedure

Narrative

Description of Event or Problem

PT UNDERWENT ENUCLEATION PROCEDURE (DATE UNK) FOLLOW BY IMPLANTATION OF HYDROXYAPATITE ORBITAL PROSTHESIS IMPLANT ALONG WITH OCU-GUARD ORBITAL IMPLANT WRAP. AT 2 MONTHS POST-IMPLANT, PT PRESENTED WITH EXPOSURE OF IMPLANT, REQUIRING REMOVAL OF THE DEVICE.