INFUSE BONE GRAFT
Received Jan 8, 2010
Report 1030489-2010-00013 · MDR key 1574865
Device
Generic name
Infuse Bone Graft
Manufacturer
Medtronic Sofamor Danek Usa, Inc.Model number
NACatalog number
UNK
Lot number
UNK
Product problems
- No Apparent Adverse Event
Patient
UNK
- Swelling
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OMF SURGERY WHERE RHBMP-2/ACS WAS USED IN THE MANDIBLE TO PROMOTE BONEY GROWTH FOR DENTAL IMPLANTS. THE PATIENT REPORTS SIGNIFICANT SWELLING POST OP, ACCOMPANIED BY DISCOMFORT. REPORTEDLY, SOME SWELLING STILL REMAINS 3.5 MONTHS POST OP.
Additional Manufacturer Narrative
A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL PRODUCT INFORMATION. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.