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 Neuropathy (1983); Pain (1994); Urinary Frequency (2275); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that the patient underwent a transforaminal and posterolateral fusion surgery at l4-l5 using rhbmp-2/acs placed into the l4-5 interspace and facet joint.Post-op, the patient developed increasing low back pain and radiculopathy into his lower extremities.Severe pain and symptoms compelled the patient to undergo revision surgery.The patient continued to experience low back pain and left leg radiculopathy.He had difficulty in sitting, standing and walking for prolonged periods, and experienced urinary frequency.

Manufacturer Narrative

(b)(4): neither the device nor applicable imaging study films or patient medical records 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/used 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.

Manufacturer Narrative

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

Event Description

It was reported that the patient was presented with the following pre-op diagnosis: 1.Status post motor vehicle accident with re-herniation l4-5.2.Severe extrusion l4-5, left with severe l5 nerve root compression and left-sided foot drop.3.Significant kyphosis on standing films at l4-l5.4.Morbid obesity preoperatively.5, previous history of laminectomy l4-5, left.He underwent following procedures: 1.Revision decompression l4-5, left with total facetectomy and lysis of adhesions.2.Transforaminal lumbar interbody fusion l4-5 through left facetectomy approach.3.Insertion of intervertebral biomechanical device l4-l5.4.Posterolateral fusion l4-ls (right facet technique).5.Non-segmental pedicle screw instrumentation l4-5 with minimally invasive technique).6.Harvest of local autograft bone from total facetectomy.7.Aspiration of right iliac crest bone marrow.As per operative notes, ¿a combination of rhbmp-2/acs, of vitoss and the local bone were then packed into the l4-5 interspace to create an interbody fusion.When this had been completed trial sizers were placed in the disk space and the best-fitting sizer was 11 mm.An 11mm peek intervertebral biomechanical device was packed with locally harvested autograft bone tamped into position and appropriately rotated.This was in excellent position in ap and lateral images.At this point, the wilson frame was let down to increase lordosis and the graft was pushed somewhat further.It was in excellent position." the patient was presented with the following post-op diagnosis: 1.Status post motor vehicle accident with re-herniation l4-5.2.Severe extrusion l4-5, left with severe l5 nerve root compression and left-sided foot drop.3.Significant kyphosis on standing films at l4-l5.4.Morbid obesity preoperatively.5.Previous history of laminectomy l4-5, left.6.Morbid obesity made decompression and fusion more challenging than usual.7.Severe epidural scarring l4-5 left made decompression and fusion much more challenging than usual requiring extensive lysis of adhesions and causing significant difficulty with visualization.No intra-op 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: 4485041
• MDR Text Key: 5567503
• Report Number: 1030489-2015-00233
• 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: 04/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• 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: 04/02/2018
• 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; Required Intervention