InjuryMTZ
OCU-GARD
Received Nov 14, 2003
Report 2183620-2003-00046 · MDR key 496093
Device
Generic name
Orbitial 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)
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
PATIENT UNDERWENT ENUCLEATION PROCEDURE (DATE KNOWN) FOLLOWED BY IMPLANTATION OF HYDROXYAPATITE ORBITAL PROSTHESIS IMPLANT ALONG WITH OCU-GARD ORTIBAL IMPLANT WRAP. AT APPROXIMATELY 8 MONTHS POST-IMPLANT, PATIENT PRESENTED WITH EXPOSURE, REQUIRING MULTIPLE REPAIRS.