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 Osteolysis (2377)

Event Type  Injury  

Event Description

It was reported that the patient underwent a dlif procedure using rhbmp-2/acs with an interbody device.Bmp was placed in the interbody device in the disc space.The surgeon reports that there was no endplate violation during the procedure, but the endplate may have been compromised due to osteoporosis.Approximately one year post-op, the ct and mri films showed some vertebral body osteolytic activity.

Manufacturer Narrative

(b)(4).Review of radiographic imaging found as follows: this patient underwent dlif at l4.Unilateral pedicle screws were used.Ap and lateral x-rays, ct axial and sagittal as well as mri are available for review.Small amount of edematous areas are noted around the screw tips and at the endplates above and below the clydesdale spacer.Small amount of osteolysis is noted in the anterior aspects of the endplates that are small enough not to be structural.

• 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: 4154982
• MDR Text Key: 21494863
• Report Number: 1030489-2014-03955
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/09/2014

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: 09/09/2014
• Initial Date FDA Received: 10/09/2014
• 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
• Treatment: INTERBODY SPACER
• Patient Outcome(s): Other