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

Catalog Number 7510600

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

Patient Problems Unspecified Infection (1930); Pain (1994); Stenosis (2263); No Code Available (3191)

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) 2009, (b)(6) 2010, the patient presented with radicular pain and underwent transforaminal epidural steroid injection at the l5-s1 level bilaterally.On (b)(6) 2009, the patient presented with neck and right arm pain, back and left foot pain.The patient was administered bilateral l5-s1 transforaminal epidural steroid injections.On (b)(6) 2009, the patient was diagnosed with lumbar degenerative disc disease.Lumbar radicular pain.Status post l3-l5 fusion.She underwent transforaminal epidurogram, left l5-s1, right l5-s1.Transforaminal epidural injection left l5-s1, right l5-s1.Epidurogram interpretation and supervision left l5-s1, right l5-s1.Interpretation of epidurogram : there was foraminal spread with contrast passing caudad and cephalad in the lateral recess covering the l5-s1 disc.On (b)(6) 2010, the patient was admitted with l5-s1 spondylosis with adjacent level degeneration.She underwent removal of instrumentation, l3 through l5, with ls-81 minimally invasive posterior lumbar interbody fusion.The interbody space was carefully dilated open and then sized using the smooth trials, and the appropriate peek interbody spacer was chosen.Half of a small infuse bmp kit was placed within the spacer.The other half was placed into the disk space prior to insertion of the spacer.During insertion of the interbody cage, the traversing and exiting nerve roots were protected with nerve root retractors placed within the disk space.Excellent purchase was obtained within the disk space.The remaining bone graft from the facetectomy and laminectomy was then packed into the interbody space.A valsalva maneuver was performed to confirm there were no inadvertent dural defects.None were found.The surgical corridor was then copiously irrigated with normal saline.A thin layer of fibrin sealant was placed over the annulotomy site to seal in the interbody graft.A round of fluoroscopic imaging was performed to confirm satisfactory implant placement and overall alignment.On (b)(6) 2010, (b)(6) 2011, the patient underwent x-ray of the lumbar spine.This shows no abnormal motion, no vacuum disc, and there is interim mineralization of the interbody space consistent with a fusion.Mri of the lumbar spine shows improvement on the left side at the surgical site.No new areas of compression elsewhere.On (b)(6) 2010, the patient underwent an mri.Review: the mis tlif approach was from the left side and there are expected postoperative changes at that level.On the right side there was no undue inflammatory reaction, nerve compression or disc bulge that would explain her symptoms.On (b)(6) 2010, the patient presented with intractable low back pain and right leg pain.She underwent right l5-s1 transforaminal epidural steroid injection.On (b)(6) 2010, the patient was discharged.On (b)(6) 2010, the patient presented with right lower extremity pain, thought to be of sympathetic etiology.The patient underwent the following procedure: right lumbar sympathetic block.On (b)(6) 2010, the patient presented with low back pain and lower extremity pain.She underwent l5-s1 transforaminal epidural steroid injection bilaterally.On (b)(6) 2010, the patient presented with low back pain and lower extremity pain and underwent transforaminal epidural steroid injection at the l5-s1 level bilaterally.On (b)(6) 2011, the patient was diagnosed that she retained small instrumentation l5-s1 with recurrent stenosis and possible pseudoarthrosis.The patient underwent the following procedures: removal of hardware with exploration of fusion.Revision decompression left l5-s1.Refusion right l5-s1 posterior in situ.On (b)(6) 2011, the patient presented with right piriformis muscle pain.The patient was administered right piriformis muscle injection.On (b)(6) 2011, the patient presented for follow up.She has continued pain radiating down the right buttock, back and all the way to the right foot.On (b)(6) 2011, the patient presented for a follow up with pain in the low back and right buttock area radiating down to her foot.On (b)(6) 2011, the patient presented with back and hip girdle pain and continued right sided pain.The patient underwent the following procedures: right greater trochanteric bursa injection.Right piriformis injection.Right sacroiliac joint injection on (b)(6) 2011, the patient presented with failed back surgery syndrome with continued back and bilateral lower extremity pain.She underwent the following procedure implantation of spinal cord stimulation, battery and leads.The patient also underwent fluoroscopy.On (b)(6) 2012, the patient was admitted with degenerative disk disease with failed back surgery syndrome with continued low back and right lower extremity pain in the l5-s1 distributions.The patient underwent l5-s1 epidural steroid injection.On (b)(6) 2012, the patient presented with right sciatica and was administered l5-s1 epidural steroid injection.On (b)(6) 2012, the patient presented with back pain.The patient underwent implantation of intrathecal catheter.The patient was admitted for observation after implantation of intrathecal catheter for intraspinal analgesia trial.On (b)(6) 2012, the patient presented for implantation of pump and intrathecal catheter for intraspinal analgesia.Impression: failed back surgery syndrome with continued back and bilateral lower extremity pain, status post implantation of spinal cord stimulation apparatus with subjective feeling of heating in the battery site area.The spinal cord stimulation apparatus was not used because of the above.The patient is status post intraspinal analgesia trial with favorable results.

• 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: 5079751
• MDR Text Key: 25884818
• Report Number: 1030489-2015-02372
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2011
• Device Catalogue Number: 7510600
• Device Lot Number: M110809AAG
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/05/2009
• 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
• Patient Weight: 75