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 Information (3190)

Event Date 08/01/2014

Event Type  Injury  

Event Description

It was reported that the thompson reuters marketscan commercial claims and encounters database was analyzed for patients undergoing a primary cervical spine (c2-c7) fusion between 2002 to year 2009.These analyses consist of 61,937 patients with one-year continuous insurance enrollment following a primary (c2-c7) cervical spine fusion.The majority of fusions utilized an anterior approach (92.8%, n=57,484) with a smaller proportion of posterior (5.2%, n=3,209) and circumferential (2.0%, n=1,244) approaches.Bmp was used in 1,677 patients.Of the bmp patients, 1,479 underwent an anterior approach procedure, 138 underwent a posterior approach procedure, and 60 underwent a circumferential procedure.Indications for surgery were degenerative disk disease for 1,229 patients and other conditions for 448 patients.The 64 patients required occupational therapy within one year post-op.

Manufacturer Narrative

Article citation: goode et al.Complications, revision fusions, re-admissions and utilization over a one-year period following bone morphogenetic protein use during primary cervical spine fusions.The spine journal (2014), doi: 10.1016/j.Spinee.2013.11.042.Implant date: 2002-2009.Average age 50.0 yrs (sd 8.1); 946 females, 731 males.(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: 4156838
• MDR Text Key: 20124375
• Report Number: 1030489-2014-03985
• 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: 09/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2014
• 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: 09/09/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 00050 YR