InjuryMTZ

OCU-GUARD

Received Nov 14, 2003

Report 2183620-2003-00042 · MDR key 495733

Device

Generic name

Orbital Implant Wrap

Manufacturer

Synovis Surgical Innovations

Model number

UNK

Catalog number

Lot number

UNK

Product problems

Explanted

Patient

UNKNOWN

Other (for use when an appropriate patient code cannot be identified)
Surgical procedure

Narrative

Description of Event or Problem

PT UNDERWENT ENUCLEATION PROCEDURE (DATE UNK) FOLLOWED BY IMPLANTATION OF HYDROXYAPATITE ORBITAL PROSTHESIS IMPLANT ALONG WITH OCU-GUARD ORBITAL IMPLANT WRAP. AT APPROXIMATELY 8 MONTHS POST-IMPLANT, PT PRESENTED WITH EXPOSURE, REQUIRING REMOVAL OF THE DEVICE.