InjuryMTZ
OCU-GUARD
Received Oct 8, 2003
Report 2183620-2003-00022 · MDR key 488971
Device
Generic name
Orbital Implant Wrap
Manufacturer
Synovis Surgical InnovationsModel number
UNKCatalog number
*
Lot number
UNK
Product problems
- Explanted
- Melted
Patient
44 YR
- Surgical procedure
Narrative
Description of Event or Problem
IN 2000 (EXACT DATE UNKNOWN), PATIENT UNDERWENT ENUCLEATION PROCEDURE FOLLOWED BY IMPLANTATION OF HYDROXYAPATITE ORBITAL PROSTHESIS IMPLANT ALONG WITH OCU-GUARD ORBITAL IMPLANT WRAP. AT EIGHTEEN WEEKS POST-OP PATIENT PRESENTED WITH 10 MM CONJUNCTIVAL MELT OVER OCU-GUARD WRAP. AT FIVE MONTHS POST-OP PATIENT UNDERWENT CONJUNCTIVOPLASTY SURGERY. PATIENT POST-OP STATUS: PATIENT RETAINED ORBITAL IMPLANT.