InjuryMTZ
OCU-GUARD
Received Oct 8, 2003
Report 2183620-2003-00025 · MDR key 488984
Device
Generic name
Orbital Implant Wrap
Manufacturer
Synovis Surgical InnovationsModel number
UNKCatalog number
*
Lot number
UNK
Product problems
- Explanted
- Melted
Patient
27 YR
- Surgical procedure
Narrative
Description of Event or Problem
IN 2000 (EXACT DATE UNKNWON), PATIENT UNDERWENT ENUCLEATION PROCEDURE FOLLOWED BY IMPLANTATION OF POROUS POLYPROPYLENE ORBITAL PROSTHESIS IMPLANT ALONG WITH OCU-GUARD ORBITAL IMPLANT WRAP. AT TEN WEEKS POST-OP PATIENT PRESENTED WITH 21 MM CONJUNCTIVAL MELT OVER OCU-GUARD WRAP. AT SIX MONTHS POST-OP ORBITAL IMPLANT WAS REMOVED. PATIENT POST-OP STATUS: UNKNOWN.