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 Problems Cyst(s) (1800); Neuropathy (1983); Pain (1994); Weakness (2145); Stenosis (2263); Numbness (2415); Nerve Proximity Nos (Not Otherwise Specified) (2647); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that the patient underwent a transforaminal lumbar interbody fusion surgery from l5-s1 where rhbmp-2/acs was implanted along the posterolateral gutters bilaterally, and along the facet joint.Post-operatively, the patient experienced pain in his lower back that radiates down his lower right extremity.Four years post-op, a mri scan revealed enhancement of presumed granulation tissue posterior to the disc space at his rhbmp-2/acs surgical site that continues to surround the thecal sac and cause severe stenosis.A small renal cyst is also seen on this scan.The patient has continued to experience low back pain, lower right extremity weakness and numbness, and left-sided foot drop.

Manufacturer Narrative

(b)(6).(b)(4).Foot drop.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

(b)(6).

Event Description

It was reported that on (b)(6) 2010 the patient underwent lumbar surgery.Preoperative diagnosis: severe l5-s1 lumbar canal stenosis, large central l5-s1 disc herniation, severe right greater than left foraminal stenosis l5-s1 subsequent to degenerative changes and disc bulge with previous l5-s1 partial laminectomy and surgery.Perop notes: after good exposure was made, levels were confirmed with fluoroscopy guidance, pedicle screws were passed through the pedicles into the vertebral body at l5 and s1 in the standard fashion using the gear shifter, followed by sounding holes, followed by placement of 6.5mm pedicle screws bilaterally at l5 and 7.5mm pedicle screws bilaterally at s1.Facetectomy was completed along the right hand side at l5-s1 and this was extended through the midline.Good decompression wazs obtained along the left hand side.This was confirmed with a woodson.After the retraction discectomy was completed, bmp and autograft was packed into the disc space.Next, autograft was packed into a 8mm cage, which was tapped into the disc space as well.After that was completed, the caps were loosened and then tightened and torqued off bilaterally at l5 and s1.Mixed with autograft, allograft and bmp.Next, the transverse processes of l5 and s1 were well decorticated bilaterally along the facet joint on the left at l5-s1.

• 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: 4458072
• MDR Text Key: 5427489
• Report Number: 1030489-2015-00194
• 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: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2012
• Device Catalogue Number: 7510200
• Device Lot Number: M110806AAM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/21/2010
• 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