InjuryMTZ
OCU-GARD
Received Nov 14, 2003
Report 2183620-2003-00044 · MDR key 496088
Device
Generic name
Orbital Implant Wrap
Manufacturer
Synovis Surgical InnovationsModel number
UNKCatalog number
*
Lot number
UNK
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNKNOWN
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
PATIENT UNDERWENT ENUCLEATION PROCEDURE (DATE UNKNOWN) FOLLOWED BY IMPLANTATION OF HYROXYAPATITE ORBITAL PROSTHESIS IMPLANT ALONG WITH OCU-GARD ORBTIAL IMPLANT WRAP. AT APPROXIMATELY 8 MONTHS POST-IMPLANT, PAITENT PRESENTED WITH EXPOSURE, REQUIRING REMOVAL OF THE DEVICE.