MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK, INC. INFUSE® BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD, OSTEOI

Model Number 7510800

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

Patient Problems Abscess (1690); Bacterial Infection (1735); Purulent Discharge (1812)

Event Date 10/31/2016

Event Type  malfunction  

Event Description

Patient underwent surgery two months ago for lumbar laminectomy.The patient had use of autograft and allograft for fusion.Patient was readmitted and diagnosed with an epidural abscess.Patient taken to or for incision and drainage and noted to have frank purulent material.Cultures came back positive for norcarida.Per hospital infectious disease provider, this is extremely unusual.No other known cases at this organization.There are a few published reports of post-op norcarida infections.Questioning if source could have been cadaveric bone.Difficult to determine if infection occurred intra-op versus during post-op phase.

• Brand Name: INFUSE® BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD, OSTEOI
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK, INC.; 4340 swinnea road; memphis TN 38118
• MDR Report Key: 6364720
• MDR Text Key: 68532909
• Report Number: 6364720
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2017,02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7510800
• Device Catalogue Number: 7510800
• Device Lot Number: MH70786AAB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 78 YR