Literature citation: author(s): mohamed macki, md, sbaa syeda, bs, kenan rajjoub, ba, panagiotis kerezoudis, md, ali bydon, md, jean-paul wolinsky, md, timothy witham, md, daniel m.Sciubba, md, mohamad bydon, md, ziya gokaslan, md "the effect of smoking status on successful arthrodesis after lumbar instrumentation supplemented with rhbmp-2." 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.
|
It was reported by in a publication titled "the effect of smoking status on successful arthrodesis after lumbar instrumentation supplemented with rhbmp-2 ", the primary objective of this study is to examine the effects smoking status on rhbmp-2 supplementation in spinal fusion constructs.The study was carried out with respect to two groups, smokers (82 patients) and non-smokers (28).All operations included arthrodesis supplementation with rhbmp-2.Fusions with greater than 1 interbody cages as well as fusions in the anterior approach were excluded.Pediatric cases were also not examined.Post-op, out of the 82 patients, 4 patients reported wound infection.
|