InjuryMTZ

OCU-GUARD

Received Oct 8, 2003

Report 2183620-2003-00036 · MDR key 488966

Device

Generic name

Orbital Implant Wrap

Manufacturer

Synovis Surgical Innovations

Model number

UNK

Catalog number

Lot number

UNK

Product problems

Melted
Device remains implanted

Patient

4 YR

Surgical procedure

Narrative

Description of Event or Problem

IN 2001 (EXACT DATE UNK), PT UNDERWENT ENUCLEATION PROCEDURE FOLLOWED BY IMPLANTATION OF HYDROXYAPATITE ORBITAL PROSTHESIS IMPLANT ALONG WITH OCU-GUARD ORBITAL IMPLANT WRAP. AT TWELEVE MONTHS POST-OP PT PRESENTED WITH 8 MM CONJUNCTIVE MELT OVER OCU-GUARD WRAP; PT UNDERWENT INTERVENTION WITH FASCIA GRAFT. PT POST-OP STATUS: PT RETAINED ORBITAL IMPLANT.