OtherMBP
CEM-OSTETIC PUTTY
Received Apr 25, 2005 · Event occurred May 12, 2004
Report 3003586733-2005-00006 · MDR key 597446
Device
Generic name
Osteoinductive Bone Void Filler
Manufacturer
Berkeley Advanced Biomaterials, Inc.Model number
CEMO-30PCatalog number
CEMO-30P
Lot number
CEM03GR7
Product problems
- Explanted
Patient
*
- Seroma
- Surgical procedure
- Therapy/non-surgical treatment, additional
- Drainage
Narrative
Description of Event or Problem
PT INITIALLY DRAINED FROM THE ILIAC CREST HARVEST SITE. THE WOUND THEN APPEARED TO HEAL. GREATER THAN ONE WEEK POST SURGERY, DRAINAGE RECURRED AND CONTAINED GRAFT MATERIAL FROM THE WOUND. THE WOUND WAS WASHED OUT - IRRIGATION AND DEBRIDEMENT. THE SITE THEN HEALED UNEVENTFULLY. CULTURES WERE NEGATIVE. THERE WAS NO EVIDENCE OF INFECTION. OUTCOME: HEALED UNEVENTFULLY.