INFUSE BONE GRAFT
Received May 28, 2010 · Event occurred Jul 18, 2006
Report 1030489-2010-00754 · MDR key 1705942
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
- Appropriate Device Problem Term/Code Not Available
Patient
UNK
- Wound Dehiscence
- No Code Available
Narrative
Additional Manufacturer Narrative
(B) (4). GRANULATION TISSUE FORMATION. LITERATURE ARTICLE CITATION: DICKINSON ET AL. REDUCED MORBIDITY AND IMPROVED HEALING WITH BONE MORPHOGENIC PROTEIN-2 IN OLDER PTS WITH ALVEOLAR CLEFT DEFECTS. PLASTIC AND RECONSTRUCTIVE SURGERY JOURNAL 2008; 209-217. A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFO. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVAL. THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.
Description of Event or Problem
IT WAS REPORTED THAT A PT UNDERWENT A PROCEDURE TO CLOSE AN ALVEOLAR DEFECT USING INFUSE. IT WAS REPORTED POST-OP THAT THE PT EXPERIENCED PROLONGED WOUND HEALING AND GRANULATION TISSUE GROWTH. NO FURTHER COMPLICATIONS WERE REPORTED.