MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

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.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6434957
• MDR Text Key: 70861231
• Report Number: 1030489-2017-00602
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 03/27/2017
• Supplement Dates Manufacturer Received: 03/01/2017
• Supplement Dates FDA Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR