InjuryMTZ
OCU-GUARD
Received Oct 8, 2003
Report 2183620-2003-00019 · MDR key 488952
Device
Generic name
Orbital Implant Wrap
Manufacturer
Synovis Surgical InnovationsModel number
UNKCatalog number
*
Lot number
UNK
Product problems
- Explanted
Patient
29 YR
- Other (for use when an appropriate patient code cannot be identified)
- Surgical procedure
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
IN 2001, PT UNDERWENT ENUCLEATION PROCEDURE FOLLOWED BY IMPLANTATION OF POROUS POLYPROPYLENE ORBITAL PROSTHESIS IMPLANT ALONG WITH OCU-GUARD ORBITAL IMPLANT WRAP. AT EIGHT WEEKS POST-OP PT PRESENTED WITH 18MM CONJUNCTIVAL MELT OVER OCU-GUARD WRAP. PT UNDERWENT MULTIPLE INTERVENTIONS INCLUDING: CONJUNCTIVOPLASTY TWICE, FASCIA GRAFT, DERMIS GRAFT AND FINALLY REMOVAL OF THE ORBITAL IMPLANT AT FIVE MONTHS POST-OP. PT POST-OP STATUS: UNKNOWN.