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 12/01/2014

Event Type  Injury  

Event Description

It was reported in a publication that a total of 72 consecutive patients who were treated with a multi-level acdf using bcs and rhbmp-2 at a single institution between 2007 and 2012 were identified and included for analysis.Clinical outcomes and patient satisfaction were collected at preoperative and prospectively at 1, 3, 6, 12, and 24 months postoperative.All patients had initial x-rays within 24 hours of surgery, ap and lateral x-rays at 4 to 6 weeks postoperative, and serial x-rays with flexion and extension views at 3, 6, 12, and 24 months.Fusion was defined as a lack of instrumentation failure, no lucency in the intervertebral disc space, and no movement on flexion-extension radiographs.Mean follow-up of the 72 patients was 13.8 months (range 6-24 months).Primary clinical indication for surgery was classified as cervical spondylitic myelopathy (csm) in 29 (40%) patients, as radiculopathy (rad) in 27 (38%) patients, as a combination of csm and rad in 15 (21%) patients, and non-union in 1 (1%) patient.There were no cases of infection or wound problems, hematoma formation, or new postoperative neurologic deficit.Overall fusion was 98.6% of patients or 99.5% of treated levels.Although postoperative dysphagia was a common side effect of acdf immediately after surgery, 38 (53%) patients complained of persistent dysphagia beyond the first postoperative visit (2 weeks), 55% of which resolved by 1 month, 34% by 3 months, and 5% by 6 months, all without additional intervention.Two of the 38 patients were readmitted for observation and steroid administration due to worsening dysphagia and/or excessive prevertebral swelling (admission primarily for airway concerns).Each of these two patients received 0.5mg rhbmp-2 at each level treated.One patient was treated at four levels and the other was treated at two levels.

Manufacturer Narrative

(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: 4631718
• MDR Text Key: 5613685
• Report Number: 1030489-2015-00651
• 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: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• 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
• Date Manufacturer Received: 02/25/2015
• 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