MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
|
Back to Search Results |
|
Catalog Number 7510200 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Hematoma (1884); Inflammation (1932)
|
Event Type
Injury
|
Event Description
|
Implant dates: unk pt demographics: unk it was reported that multiple patients underwent multi-level 360 (anterior-posterior interbody fusion) procedures using rhbmp-2/acs on unknown dates.Post-op, the patients experienced neuritis and hematomas but with no issues.The surgeon mentioned that the adverse event occurred when he used a higher concentration of bmp2.There was no additional information provided.
|
|
Manufacturer Narrative
|
(b)(4).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.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
|
|
Search Alerts/Recalls
|
|
|