INFUSE BONE GRAFT
Received May 28, 2010 · Event occurred Sep 10, 2009
Report 1030489-2010-00734 · MDR key 1705957
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
- Swelling
Narrative
Additional Manufacturer Narrative
(B) (4). LITERATURE ARTICLE CITATION: ALONSO ET AL. MAXILLARY ALVEOLAR RECONSTRUCTION ON CLEFT LIP AND PALATE PTS USING RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2. COMPARISON WITH AUTOGENOUS BONE GRAFTING. TISSUE ENGINEERING. 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.
Description of Event or Problem
IT WAS REPORTED THAT THE PT UNDERWENT AN ALVEOLAR BONE GRAFTING PROCEDURE USING RHBMP-2/ACS. IT WAS REPORTED THAT THE PT EXPERIENCED SIGNIFICANT SWELLING IN THE EARLY POST OP PERIOD. THE SWELLING RESOLVED UNEVENTFULLY. PER THE REPORTER, THIS WAS NOT ATTRIBUTED TO BMP. NO FURTHER PT COMPLICATIONS WERE REPORTED.