InjuryGXO
DURA-GUARD
Received Jul 18, 2003 · Event occurred Jun 1, 2003
Report 2183620-2003-00014 · MDR key 472703
Device
Generic name
Dural Repair Patch
Manufacturer
Synovis Surgical InnovationsModel number
UNKCatalog number
*
Lot number
UNK
Product problems
- Explanted
Patient
UNKNOWN
- Inflammation
- Treatment with medication(s)
Narrative
Description of Event or Problem
IN 06/2003 MANUFACTURER WAS NOTIFIED OF A PT WHO EXHIBITED WHAT APPEARED TO BE AN ACUTE INFLAMMATORY RESPONSE FOLLOWING IMPLANTATION OF DURA-GUARD (EXACT DATE UNK). THE DEVICE WAS THEN EXPLANTED (2003, EXACT DATE UNK) RESULTING IN A REDUCTION OF THE PT'S SYMPTOMS. PT STATUS WAS THEN ASSESSED AS "BETTER".