OtherMBP
CEM-OSTETIC PUTTY
Received Apr 25, 2005 · Event occurred May 7, 2004
Report 3003586733-2005-00005 · MDR key 597453
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
65 YR
- Seroma
- Surgical procedure
- Organ Dehiscence
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
TWO TO THREE WEEKS POST SURGERY PT PRESENTED WITH SEROMA FORMATION, WOUND DEHISCENCE OCCURRED. IRRIGATED AND DEBRIDED ONCE WITH EVACUATION OF MATERIAL. WOUND WAS CLOSED WITHOUT DRAINS. WOUND HEALED UNVEVENTFULLY. CULTURES WERE NEGATIVE WITH NO EVIDENCE OF INFECTION. OUTCOME: HEALED UNEVENTFULLY.