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 Death (1802)

Event Date 05/02/2014

Event Type  Death  

Event Description

It was reported that a matched cohort of 52,259 patients undergoing thoracolumbar fusion surgery from 2006 to 2010 in the united states was identified in the marketscan database.Patients without bmp treatment (n=34,840) were matched 2-to-1 to patients receiving bmp (n=17,455).1600 pts underwent anterior procedures, 11912 underwent posterior decompression, and 16237 had posterior instrumentation.2762 patients had complications within 30 days of surgery.Rates of hematoma, pulmonary complications, pe, neurological complications, new malignancy, 30-day readmission rate, mortality at in dex procedure, mortality at 30 ¿day follow up, retrograde ejaculation, infertility, and antidepressant prescription were not statistically significantly different between the bmp treatment and the control groups.There were statistically significantly higher rates of infection, wound dehiscence, and wound complications in the control group.Five patients died at index procedure.

Manufacturer Narrative

Article citation: veeravagu et al.The use of bone morphogenetic protein in thoracolumbar spine procedures: analysis of the marketscan longitudinal database.The spine journal (2014).Doi: 10.1016/j.Spinee.2014.05.010.Mean age 53.5 yrs.Sex: 10049 females, 7406 males.Date of death unknown.Implant date: 2006-2010.User facility: not reported.(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: 3884875
• MDR Text Key: 4649409
• Report Number: 1030489-2014-02819
• 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: 05/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• 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: 05/21/2014
• 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): Death
• Patient Age: 00054 YR