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)

Event Type  Injury  

Event Description

It was reported that an integrated health system¿s spine registry was used to retrospectively identify patients who underwent spine fusion surgery between (b)(6) 2009 and (b)(6) 2012.Using this data, patient characteristics, bmp-2 dosage (if used), region of the spine fused, and number of levels fused were extracted.Data was also cross-matched with the institution¿s cancer registry to identify any de novo diagnoses of cancer in these patients.Using logistic regression analysis, the risk of malignancy following spine surgery with and without bmp-2 administration was determined.In the cohort of 10,416 patients, 5,987 patients underwent a fusion procedure with bmp-2 while 4,429 patients underwent fusion without bmp-2.De novo cancer diagnoses were found in 73 patients in the bmp-2 group (1.2%), compared to 47 patients in the non-bmp group (1.1%, p=0.454).Average length of follow-up for patients in the bmp-2 group was 2.2 years, compared to 1.9 years for the non-bmp group.After adjusting for age, gender, bmi, asa score, and smoking stat us, no significant effect of bmp-2 on the development of cancer was identified (or 1.06, 95% ci 0.58-1.92).There was no evidence that the use of bmp-2 conferred an increased risk of developing cancer.

Manufacturer Narrative

Podium presentation abstract: mitsunaga et al.Bone morphogenetic protein (bmp-2) usage and cancer correlation: an analysis of 10,416 spine fusion patients from a multicenter spine registry.(b)(4).Implant dates: (b)(6) 2009 ¿ (b)(6) 2012.(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.

• 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: 4287075
• MDR Text Key: 5300786
• Report Number: 1030489-2014-04599
• 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
• Report Date: 10/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2014
• 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: 10/30/2014
• 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