InjuryMTZ

OCU-GUARD

Received Oct 8, 2003

Report 2183620-2003-00031 · MDR key 488945

Device

Generic name

Orbital Implanted Wrap

Manufacturer

Synovis Surgical Innovations

Model number

UNK

Catalog number

Lot number

UNK

Product problems

Melted
Device remains implanted

Patient

2 YR

Surgical procedure

Narrative

Description of Event or Problem

IN 2001 (EXACT DATE UNKNOWN), PT UNDERWENT ENUCLEATION PROCEDURE FOLLOWED BY IMPLANTATION OF POROUS POLYPROPYLENE ORBITAL PROSTHESIS IMPLANT ALONG WITH OCU-GUARD ORBITAL IMPLANT WRAP. AT THREE MONTHS POST-OP PT PRESENTED WITH 16 MM CONJUNCTIVAL MELT OVER OCU-GUARD WRAP; PT UNDERWENT CONJUNCTIVOPLASTY PROCEDURE. PT POST-OP STATUS: PT RETAINED ORBTIAL IMPLANT.