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 Problems Nerve Damage (1979); Pain (1994); Disability (2371)

Event Type  Injury  

Event Description

It was reported that the patient underwent a spinal fusion surgery at the lumbar region of his spine from vertebrae l4 to s1.During the surgery, rhbmp-2/acs was used in a intertransverse (posterior) surgical approach.The patient's post-operative period was marked by a period of short relief followed by severe ongoing chronic pain.The patient continues to experience severe and unrelenting back pain,nerve damage, and permanent disability.The patient continues to utilize muscle relaxers and/or pain medication.This prevents him from practicing and fully enjoying the activities of daily life to the extent he did preoperatively.No additional information has been provided.

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.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.

Event Description

It was reported that on (b)(6) 2009, patient underwent following procedure, removal of rod-screw posterior spinal instrumentation l4 through s1 including broken right s1 screw.Reinsertion of spinal instrumentation this time using posterior rod-screw l4-5, s1 and s2 screws.Osteotomy of mal-united left l5-s1 posterior lateral fusion as well as auto ossification disc space interbody fusion.Revision fusion of l5-s1 into posterior lumbar interbody fusion.Open reduction of grade ii spondylolisthesis of l5 on s1.Intra-transverse fusion of l4-5, l5-s1.Interbody spacers l5-s1 with bone morphogenic protein (bmp) and bone graft granules 15% hydroxyapatite and 85% beta tri-calcium phosphate.Combined with locally harvested bone and crushed cancellous allograft.Pre-op diagnosis: previous attempted fusion posterior lateral l4-5, l5-s1.Probable non-union l4-5, l5-s1.Broken right s1 pedicle screw.Grade ii anterolisthesis l5 on s1.Post-op diagnosis: l4-5 non-union left posterior lateral fusion, intact right intra-transverse fusion.L5-s1 non-union right posterior lateral fusion, mal-united left l5-s1 posterior lateral fusion.Severe foraminal stenosis bilateral l5-s1 with slight focal scoliosis.Active bilateral l5 radiculopathy on nerve conduction testing.Diabetes.As per op-notes: ".Initially 8mm tall x 26mm long machined allograft interbody spacer was carefully inserted and placed laterally as possible and supporting cortical bone pf vertebral body.From the right side of the mid portion of the disc space accepted two collagen sponges which had been rolled around bone graft hydroxyapatite and beta tri-calcium phosphate granules.One bmp sponge was placed transversely along the anterior disc space and one was placed in the mid-sagittal line between the two interbody spacers.The remainder of the disc space was packed with a combination of locally harvested bone and crushed cancellous bone which had been soaked in the patient's own blood.The second cage was inserted on the right side.Cross table lateral and ap c-arm fluoroscopy showed satisfactory arthrodesis construct.No complications were reported.".

• 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: 4275923
• MDR Text Key: 18928428
• Report Number: 1030489-2014-04571
• 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,consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2014
• 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?: No
• Date Manufacturer Received: 01/30/2017
• 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; Disability