InjuryMTZ
OCU-GUARD
Received Nov 14, 2003
Report 2183620-2003-00041 · MDR key 495739
Device
Generic name
Orbital Implant Wrap
Manufacturer
Synovis Surgical InnovationsModel number
UNKCatalog number
*
Lot number
UNK
Product problems
- Explanted
Patient
UNKNOWN
- Unspecified Infection
- Surgical procedure
Narrative
Description of Event or Problem
PT UNDERWENT ENUCLEATION PROCEDURE (DATE UNK) FOLLOWED BY IMPLANTATION OF HYDRAOXYAPATITE ORBITAL PROSTHESIS IMPLANT ALONG WITH OCU-GUARD ORBITAL IMPLANT WRAP. AT APPROXIMATELY 8 MONTHS POST-IMPLANT, PT PRESENTED WITH EXPOSURE, REQUIRING REMOVAL OF THE DEVICE.