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

Catalog Number 7510200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Type  Injury  

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.

Event Description

It was reported that on (b)(6) 2007 the patient presented with the following preoperative diagnosis: l4-5 degenerative disk disease with severe foraminal narrowing and l4 radiculopathy.The patient underwent the following procedures: 1.Left l4-5 fasciectomy with far lateral decompression of the l4 nerve root.2.Diskectomy and interbody fusion at l4-5 using structural peak cage, locally harvested autograph, bone morphogenic protein allograft and intraalograft.3.Percutaneous pedicle screw fixation using the pedicle screw system.4.Use of operating microscope.Per op notes: the disk was distracted open and found to be loose.With distractors up to 12 mm, pedicle screws were placed in the patient.Over the previously placed k-wires, dilation was performed, followed by tapping and the pedicle screw placement 6.5x 45 mm in length.Lock plugs were placed and provisionally tightened to maintain distraction.Bronchoscope was then brought back into the field.The retractor was removed from the patient's left and completion of discectomy was performed significantly aided by the distraction that was present 10mm graft was then chosen as the most appropriate fit.Thus, a 10mm peak cage was chosen, filled with locally harvested autograft and 1/2 of the bone morphogenic protein sponge.Disk space was then filled with intergro putty and the rest of the 1-1/2 sponge of bone morphogenic protein.The additional allograft was placed as well.Cage was then tamped into position.

• 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: 5331746
• MDR Text Key: 34568312
• Report Number: 1030489-2015-03596
• 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: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 11/30/2015

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
• Device Expiration Date: 06/01/2010
• Device Catalogue Number: 7510200
• Device Lot Number: M110701AAJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/03/2007
• 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