InjuryMTZ
OCU-GUARD
Received Oct 8, 2003
Report 2183620-2003-00027 · MDR key 489011
Device
Generic name
Orbital Implant Wrap
Manufacturer
Synovis Surgical InnovationsModel number
UNKCatalog number
*
Lot number
UNK
Product problems
- Explanted
- Melted
Patient
41 YR
- Surgical procedure
Narrative
Description of Event or Problem
IN 2001 (EXACT DATE UNKNOWN), PATIENT UNDERWENT ENUCLEATION PROCEDURE FOLLOWED BY IMPLANTAION OF HYDROXYAPATITE ORBITAL PROSTHESIS IMPLANT ALONG WITH OCU-GUARD ORBITAL IMPLANT WRAP. AT SIX WEEKS POST-OP PATIENT PRESENTED WITH 8 MM CONJUNCTIVAL MELT OVER OCU-GUARD WRAP. PATIENT UNDERWENT MULTIPLE INTERVENTIONS (DATES UNKNOWN) INCLUDING: CONJUNCTIVOPLASTY, FASCIA GRAFT, DERMIS GRAFT AND FINALLY REMOVAL OF ORBITAL IMPLANT AT TWENTY MONTHS POST-OP. PATIENT POST-OP STATUS: UNKNOWN.