MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
|
Back to Search Results |
|
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Pain (1994); Stenosis (2263); No Code Available (3191)
|
Event Type
Injury
|
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.Although it is unknown if the device contributed to the reported event, we are filing this mdr for notification purposes.
|
|
Event Description
|
It was reported that, on an unknown date in (b)(6) 2013, patient underwent lumbar fusion surgery using rhbmp-2.Post-op patient alleged pain.Reportedly, x-rays showed considerable stenosis most likely caused by excessive growth of fusion material causing considerable pain.
|
|
Search Alerts/Recalls
|
|
|