MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Injury (2348)

Event Date 04/30/2014

Event Type  Injury  

Event Description

"it was reported by tohmeh et al in a publication entitled ¿a comparison of radiographic and clinical outcomes of extreme lateral interbody fusion performed with either allograft cellular bone matrix or rhbmp-2 graft material¿ (abstract of the international society for the advancement of spine surgery (isass) 2014, 30-apr to 02-may, miami usa).That clinical data were collected through a prospective registry while radiographic data were collected through a separate prospective study.Inclusion criteria included being treated with xlif at either 1 or 2 levels with either allograft cellular bone matrix, or rhbmp-2/acs graft material.Consecutive patients at least 12 months from surgery were contacted for enrolment.Bmp patients were treated between march 2008 and march 2009 and acbm patients were treated between april 2009 and august 2011.A total of 54 patients were included in the analysis, with 33 patients and 37 levels in the acbm xlif group and 21 patients and 28 levels in the rhbmp-2/acs group.Complications included one dural tear in the bmp group and one intervertebral cage breakage (upon insertion) and one instance of knee extension weakness postop in the acbm group.Evidence of fusion on ct was found in 34/37 levels in the acbm group and 28/28 levels in the bmp group.Subsidence on ct was similar between the two groups, in 64% of bmp and 68% of acbm levels.The majority of patients with radiographic subsidence exhibited <(><<)>25% implant height settling.".

Manufacturer Narrative

(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.

• 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4799575
• MDR Text Key: 5880133
• Report Number: 1030489-2015-01064
• 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: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2015
• 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