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 Problem
Dysphagia/ Odynophagia (1815)
|
Event Type
Injury
|
Manufacturer Narrative
|
Literature citation:brendan p.Lovasik, christopher m.Holland, brian m.Howard, griffin r.Baum, gerald e.Rodts, daniel refai "anterior cervical discectomy and fusion: comparison of fusion, dysphagia, and complication rates between recombinant human bone morphogenetic protein-2 and beta-tricalcium phosphate." mean age 56 yrs, 53 male, 31 female.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.
|
|
Event Description
|
It was reported in the literature titled ¿anterior cervical discectomy and fusion: comparison of fusion, dysphagia, and complication rates between recombinant human bone morphogenetic protein-2 and beta-tricalcium phosphate¿ that 84 patients underwent acdf (anterior cervical discectomy and fusion) surgery during a 2 year period form april 2011 to april 2013 in which rhbmp-2 was used for fusion.The most common indications for surgery were any or a combination of the following: cervical myelopathy, radiculopathy, spondylosis, and anatomic instability.A smith-robinson anteromedial approach was used in all cases; all bone graft supplements were secured fully inside the peek cage or allograft and were combined with autologous bone marrow aspirate and morcelized osteophyte fragments when btcp was used.An anterior cervical plate was applied in all cases.Dosing of rhbmp2 and btcp were approximately 0.5 mg and 1.2 ml per cervical level, respectively.Nearly 1 in 5 patients (n =35, 18.3%; 17 from rhbmp-2 group) reported symptoms of postoperative dysphagia.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|
|
|