InjuryMTZ
OCU-GARD
Received Nov 14, 2003
Report 2183620-2003-00043 · MDR key 496098
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 HYDROXYAPTITE ORBITAL PROSTHESIS IMPLANT ALONG WITH OCU-GARD ORBITAL IMPLANT WRAP. AT APPROXIMATELY 8 MONTHS POST-IMPLANT, PATIENT PRESENTED WITH EXPOSURE, REQURING REMOVAL OF THE DEVICE.