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 No Code Available (3191)

Event Date 11/05/2014

Event Type  Injury  

Event Description

It was reported that patients who underwent a lumbar fusion for degenerative spondylolisthesis with at least 6 months post-op radiographs, were divided based on whether they received an osteoconductive (oc) or osteoinductive (oi) bone graft substitute.A total of 126 patients (78 oi, 48 oc) met the inclusion criteria for the assessment for fusion.The oc groups included allografts, calcium phosphate, ceramics and hydroxyapatite products.The oi group included bone morphogenic protein, demineralized bone matrix, and stem cell-based products.Using a conservative hierarchical approach to determine fusion, fusion criteria included stringent use of multiple measurement methods including flexion/extension x-rays, lenke and brantigan ct fusion measurement criteria, and history of revision surgery due to pseudoarthrosis.Ten patients in the oi group had non-fusions.

Manufacturer Narrative

Literature article citation : kurd et al.¿fusion in degenerative spondylolisthesis: comparison of osteoconductive and osteoinductive bone graft substitutes¿.Eur spine j.2014 nov 5.(b)(4): neither the device nor applicable imaging study films or patient medical records 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/used 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.

Manufacturer Narrative

The oi study group used rhbmp-2/acs, demineralized bone matrices (dbm matrix and dbm putty) and stem cell-based products.

• 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: 4290508
• MDR Text Key: 5084534
• Report Number: 1030489-2014-04607
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/06/2014

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: 11/06/2014
• Initial Date FDA Received: 12/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/08/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 00060 YR