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 Date 12/04/2014

Event Type  Injury  

Event Description

It was reported in a publication that the authors carried out a prospective, randomized trial to evaluate the efficacy of local depo medrol application in reducing the severity of postoperative dysphagia following anterior cervical fusions using low-dose rhbmp-2.Consecutive patients undergoing elective one, two and three level acdf by one of two surgeons were eligible for inclusion into the study.From august 2013 to march 2014, fifty-six patients were eligible for inclusion into the study.Fifty patients were interested in participating and provided informed consent.Twenty-seven patients were randomized to the treatment (depomedrol) group and 23 were randomized to the control (saline) group.All patients underwent a left sided smith-robinson surgical approach.Interbody fusion was carried out using a peek spacer, local bone graft, 0.35cc (0.5mg) of rhbmp-2 per level, and plate fixation.Prior to closure, a 1 x 3 cm collagen sponge was placed ventral to the plate.The sponge was saturated with either saline (1cc) or depomedrol (40mg/1cc) based on a third-party randomization table.Patients were followed for four weeks postoperatively by the study administrator.Dysphagia was measured at five time intervals (postoperative days 1,4, 7, 14 and 28) using the four-point modified dysphagia scoring system.Patients receiving local depomedrol experienced less dysphagia at all time intervals, with the differences reaching statistical significance on postoperative days 4, 7, 14, and 28 (p<(><<)>0.05).Patients in the treatment group also required less dysphagia medical management and reported overall greater satisfaction.No adverse airway events, such as prolonged intubation, re-intubation or readmission for breathing difficulty, were observed in either group.

Manufacturer Narrative

Article citation: edwards et al.Can dysphagia following anterior cervical fusions with rhbmp-2 be reduced with local depomedrol application? a prospective, randomized, placebo-controlled, double-blind trial: a prospective, randomized, placebo-controlled, double-blind trial.42nd cervical spine research society (csrs) annual meeting 2014, 04-06 dec., orlando, fl, usa.Implanted date: august 2013 to march 2014.(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.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.

• 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: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4426313
• MDR Text Key: 19314969
• Report Number: 1030489-2015-00165
• 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: 12/18/2014

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: 12/18/2014
• Initial Date FDA Received: 01/16/2015
• 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): Other