inforMED
OtherMBP

GRAFX TRICAL BVF PUTTY

Received Jan 19, 2005 · Event occurred Nov 20, 2004

Report 3003586733-2005-00001 · MDR key 573478

Device

Generic name

Osteoinductive Bone Void Filler

Model number

21-2030

Catalog number

21-2030

Lot number

HUM01R14

Product problems

  • Explanted

Patient

45 YR

  • Seroma
  • Surgical procedure
  • Therapy/non-surgical treatment, additional

Narrative

Description of Event or Problem

DEVELOPMENT OF SEROMA REPORTED AFTER IMPLANTATION OF 30CC OF PUTTY INTO THE ILIAC CREST. THE WOUND WAS ASPIRATED, REMOVING ANY ACCUMULATED FLUID AND PUTTY.