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 Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Tingling (2171)

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.Although it is unknown if the device contributed to the reported event, we are filing this mdr for notification purposes.

Event Description

It was reported that on (b)(6) 2014, patient underwent a transforaminal lumbar interbody fusion surgery on the lumbar region of his spine from vertebrae l4 to s1.Reportedly, the patient was implanted with rhbmp-2/acs in this surgery.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.The rhbmp-2 collagen sponge was placed outside a cage (in the disc space).Allegedly, "patient's post-operative period has been marked by a period of improvement, followed by progressively worsening lower back pain, and radiating left lower extremity pain and paresthesias." reportedly, "patient continues to experience chronic and extreme pain and muscle spasms in his lower back, radiating pain down his legs.".

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on: (b)(6) 2014: the patient presented with the following pre-op diagnosis: l5/s1 isthmic spondylolisthesis; l4/5 degenerative spondylolisthesis; lumbar spinal stenosis without neurogenic claudication.The patient underwent the following procedures: l4/5, l5/s1 transforaminal lumbar interbody fusion(tlif), instrumentation at l4, l5 and s1 with bilateral pedicle screws, insertion of peek interbody cage into prepared l4/5, l5/s1 disc space using local bone autograft and allograft, rhbmp-2/acs incorporating the use of operating microscope, use of computer guided navigation system for spinal instrumentation; bilateral l4/5, l5/s1 osteotomy to decrease spondylolisthesis slip.As per operative notes,¿ under fluoroscopy monitoring, the surgeon placed the rhbmp-2/acs soaked collagen sponge anteriorly to the prepared disc space.Following that surgeon packed patient's local bone autograft and allograft into the prepared l5/s1 disc space.Then surgeon placed the above stated peek interbody cage into the prepared l5/s1 disc space under fluoroscopy monitoring.The peek interbody cage was filled with allograft and local bone autograft.Placement of interbody cage gave them significant reduction of the spondylolisthesis, restoration of the disc height as well as increase in lumbar lordosis.¿ non intra-operative 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 USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6208002
• MDR Text Key: 63359564
• Report Number: 1030489-2016-03568
• 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,Followup,Followup
• Report Date: 05/22/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: 12/05/2016; 04/30/2018
• Supplement Dates FDA Received: 09/27/2017; 05/22/2018
• 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