InjuryMTZ
OCU-GARD
Received Oct 8, 2003
Report 2183620-2003-00034 · MDR key 488947
Device
Generic name
Orbital Implant Wrap
Manufacturer
Synovis Surgical InnovationsModel number
UNKCatalog number
*
Lot number
UNK
Product problems
- Melted
- Device remains implanted
Patient
2 YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
IN 2001 (EXACT DATE UNKNOWN), PATIENT UNDERWENT ENUCLEATION PROCEDURE FOLLOWED BY IMPLANTATION OF POROUS POLYPROPYLENE ORBITAL PROSTHESIS IMPLANT ALONG WITH OCU-GARD ORBTIAL IMPLANT WRAP. AT SIX MONTHS POST-OP PATIENT PRESENTED WITH 16 MM CONJUCTIVAL MELT OVER OCU-GARD WRAP; NO INTERVENTION WAS REPORTED. PATIENT POST-OP STATUS: PATIENT RETAINED ORBTIAL IMPLANT.