InjuryNPZ
INFUSE BONE GRAFT
Received Jun 17, 2010
Report 1030489-2010-00804 · MDR key 1728773
Device
Generic name
Infuse Bone Graft
Manufacturer
Medtronic Sofamor Danek Usa, Inc.Model number
NACatalog number
UNK
Lot number
UNK
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
UNK
- Osteopenia/ Osteoporosis
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PT UNDERWENT AN OMF PROCEDURE APPROX 70 MONTHS AGO USING RHBMP-2/ACS. IT WAS NOTICED 7 MONTHS POST-OP THAT THE PATIENT'S BONE WAS DECREASING.
Additional Manufacturer Narrative
(B) (4). A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADD'L DEVICE INFO. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.