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

Catalog Number 7510100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 04/01/2015

Event Type  Injury  

Event Description

It was reported in a publication that the authors retrospectively reviewed the clinical and radiographic outcomes of all 3-level acdfs with 0.26 to 0.35 mg/level of rhbmp-2 performed between 2008 and 2011.The study (b)(6) included 37 consecutive patients.No patient was lost to follow-up.The primary indication for surgery was symptomatic spondylotic myelopathy.All patients were given a preoperative intravenous (iv) dose of methylprednisolone to decrease postoperative dysphagia and airway complications.All anterior fusions were performed through a smith-robinson approach.Recombinant human bmp-2 was prepared at a concentration of 0.26 to 0.35 mg/level (between one-eighth and one-sixth of an extra-small sponge 1.4 ml at 1.5 mg/ml) with corticocancellous allograft (vg2 allograft; depuy synthes spine).Four millimeter drill holes were made in the top and bottom of the allograft spacers, and the rhbmp-2 was placed in these holes.A fibrin sealant (tisseel) was placed anteriorly over the grafts for containment of the rhbmp-2 from the anterior structures.Five (14%) patients had a single cervical corpectomy adjacent to an acdf at the index surgery.In all cases, an eagle anterior cervical locking plate (depuy synthes spine) was used.Cervical drains were used in all cases.Postoperatively, all patients were placed on an iv tapered dose of methylprednisolone while in the hospital and converted to an oral tapered dose at discharge.Patients were discharged once liquids were tolerated.A hard collar was worn for the first 2 weeks, followed by a soft collar for 2 weeks.Physical therapy was initiated approximately 6 weeks postoperatively and included bilateral shoulder girdle modalities addressing pain and stiffness.The authors observed no airway or cervical swelling complications.Mean swelling anterior to the c2 and c3 vertebral bodies 2 weeks postoperatively was 4.8 and 9.6 mm, respectively.12 patients reported dysphagia at 2-week follow-up (8 mild, 3 moderate, 1 severe), 19 (51%) continued to have dysphagia at 6 weeks (16 mild, 3 moderate), and 6 (16%) reported dysphagia at 6 months (6 mild).Four (11%) patients reported dysphagia at latest follow-up.One of these patients had the anterior cervical plate removed due to the dysphagia, but it did not completely resolve 6 months after removal of the plate.

Manufacturer Narrative

Article citation: pourtaheri et al.Ultra-low-dose recombinant human bone morphogenetic protein-2 for 3-level anterior cervical diskectomy and fusion.Orthopedics.2015 apr 1;38(4):241-245.(b)(6).(b)(4).

• 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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4793300
• MDR Text Key: 5814009
• Report Number: 1030489-2015-01032
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2015
• 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): Required Intervention
• Patient Age: 00055 YR