OtherMBP
CEM-OSTETIC PUTTY
Received Apr 25, 2005 · Event occurred Mar 15, 2004
Report 3003586733-2005-00008 · MDR key 597439
Device
Generic name
Osteoinductive Bone Void Filler
Manufacturer
Berkeley Advanced Biomaterials, Inc.Model number
CEMO-30PCatalog number
CEMO-30P
Lot number
*
Product problems
- Explanted
Patient
*
- Erythema
- Swelling
- Surgical procedure
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
ICBG HARVEST THROUGH SEPARATE INCISION ON THIN PT. SWELLING AND ERYTHEMA OVER THE ICBG SITE TWO WEEKS POST PROCEDURE. NO DEHISCENCE. SURGEON CHOSE TO WASH OUT. IRRIGATION AND DEBRIDEMENT PERFORMED WITH REMOVAL OF BONE GRAFT MATERIAL. WOUNDS HEALED UNEVENTFULLY. CULTURES WERE NEGATIVE WITHOUT EVIDENCE OF INFECTION. REMAINDER OF COURSE REMARKABLE. OUTCOME: HEALED UNEVENTFULLY.