OtherMBP
CEM-OSTETIC PUTTY
Received Apr 25, 2005 · Event occurred Mar 3, 2004
Report 3003586733-2005-00004 · MDR key 597433
Device
Generic name
Osteoinductive Bone Void Filler
Manufacturer
Berkeley Advanced Biomaterials, Inc.Model number
CEMO-30PCatalog number
CEMO-30P
Lot number
CEM03GR6
Product problems
- Explanted
Patient
43 YR
- Erythema
- Unspecified Infection
- Swelling
- Surgical procedure
- Drainage
Narrative
Description of Event or Problem
ONW WEEK POST SURGERY, SWELLING AND ERYTHEMA DEVELOPED OVER THE ICBG SURGICAL SITE WITH SUBCUTANEOUS FLUID COLLECTION. SURGEON WAS CONCERNED REGARDING INFECTION AND RETURNED THE PT TO THE OPERATING ROOM FOR IRRIGATION AND DEBRIDEMENT. THE WOUND WAS CLOSED OVER DRAINS. DRAINAGE PERSISTED VIA SUTURE LINE AND SECOND DEBRIDEMENT WAS PERFORMED. WOUNDS SUBSEQUENTLY HEALD WITHOUT COMPLICATION. CULTURES WERE NEGATIVE. NO EVIDENCE OF INFECTION. OUTCOME: HEALED UNEVENTFULLY.