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

Catalog Number 7510400

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

Patient Problems Inflammation (1932); Pain (1994); Weakness (2145); Tingling (2171); Numbness (2415)

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2011, reportedly, the patient presented with pain and underwent a lumbar spine mri.On (b)(6) 2011, the patient presented with numbness and tingling in legs to feet and chronic pain in the lower back.The patient underwent a lumbar spine mri which demonstrated non-instrumental fusion at l4-5.There was clumping of nerve roots at l4-5 consistent with arachnoiditis or arachnoid adhesions.There was degenerative disc disease and facet joint disease above and below the level of the fusion with stenosis at the l3-4 and to a lesser extent l5-s1 levels.Note: there were tiny cysts seen projecting from the left kidney.The patient also underwent lumbosacral x-rays which revealed multilevel degenerative disc disease throughout the lumbar spine and a remote compression fracture of the superior endplate of l3.It was noted that the patient had been non-compliant with their regime for diabetes.On (b)(6) 2011, the patient presented with continuing low back, buttocks, hip and bilateral leg pain.The patient had advanced disc disruption at the l4-5 level with a listhesis.Per the encounter notes a previous mri had shown remote compression deformity at the l3 vertebrae with endplate changes at the l2-3, l3-4, l4-5 levels with a previous laminectomy at the l4-5 level and osseous fusion across the disc space and facets.At the level above the patient¿s surgery, there was severe spinal stenosis causing compression of the existing l3-4 roots.On (b)(6) 2011, the patient presented with pain.The most recent x-rays and mri were reviewed and they had shown a 5 mm retrolisthesis with severe exit foraminal stenosis at the l3-4 level; severe spinal canal stenosis with severe foraminal stenosis; there was some foraminal stenosis at the l5-s1 without listhesis; significant foraminal stenosis and instability of greater than 5 mm as seen on dynamic films.There was a fusion at the l5-s1 level and a posterior disc protrusion at the l3-4 level contributing to the foraminal stenosis.Surgery was discussed.On (b)(6) 2011, the patient was reported on a pre-surgery certification with lumbar spinal stenosis and lumbar intervertebral disc disorder with myelopathy.The patient had an antalgic gait and painful range of motion and some quadriceps weakness.On (b)(6) 2011, the patient presented with lower back, buttock, hip and leg pain and the preoperative diagnosis of severe spinal stenosis with spinal instability.The patient underwent an anterior lumbar interbody fusion at l3-4, placement of 15 mm x 55 mm interbody peek implant with bone morphogenic protein, l3-4; decompressive laminectomy with bilateral facetectomy and bilateral nerve root decompression, l3-4 and a posterolateral fusion, l3-4.Per the operative report ¿¿ a 15 mm height, x 18mm width x 55 mm length was serially packed with bone morphogenic protein, which was reconstituted at the onset of the case.The implant was impacted showing adequate distraction of the disc space adequate placement of the implant.¿ it should be noted that there was ¿and extremely tight central lateral recess stenosis at the l3-4 level with significant facet arthropathy, and greater than half the facets bilaterally were removed¿.Posterolateral fusion was achieved by placing morcellized graft into the decorticated lateral facet articulation and the lateral articular processes to complete the posterior fusion and the lateral articular processes.¿ ssep and emg monitoring was utilized throughout.No patient complications were noted.*globus peek* on (b)(6) 2011, the patient was discharged from hospital to a rehab facility.The patient reported they were limited in their activities secondary to pain.The patient had trouble tying their shoes.The patient was in theprocess of undergoing physical therapy.Lumbar x-rays showed interval fusion since post-operative radiographs and a slight scoliosis.On (b)(6) 2011, the patient presented with improving symptoms.The patient was utilizing a brace for ambulation.X-rays showed good positioning of the implant valium and dilaudid were continued.On (b)(6) 2011, the patient presented with low back pain.The patient underwent x-rays which showed continued evidence of settling into the interbody space.No definitive consolidation was seen at this point.The patient was to continue using their home bone growth stimulator.Medications: new roxicodone and zanaflex.The patient was also prescribed a steroid help with the acute inflammation.On (b)(6) 2012, the patient presented with back and leg pain and limited range of motion in the lumbar spine.X-rays showed continued evidence of settling.On (b)(6) 2012, the patient presented with increased and significant lower back pain.X-rays showed good positioning on instrumentation.The patient was wearing a brace.Celebrex was newly prescribed.On (b)(6) 2012, the patient presented with lumbar radiculitis and underwent a l5-s1 lumbar steroid injection.No patient complications were noted.On (b)(6) 2012, the patient presented with back pain which had not much improved since the surgery.On (b)(6) 2012, the patient presented with back pain ¿really not gotten much better¿.There was new increasing numbness in the thumb and index finger on the left hand.The patient reported difficulty flexing and picking things up due to weakness.X-rays showed a solid fusion.Medications: oxycodone and oxycotin.On (b)(6) 2012, the patient presented with pain into the neck, shoulders, and left arm in the distribution of c6.The patient also had some thumb extension weakness.On (b)(6) 2012, the patient presented with new increasing right leg ¿going to sleep king of pain¿ and weakness.Then patient also reported an incident where they had trouble getting up and walk due to diminished sensibility.The patient also presented with neck, shoulder, and left arm pain ina c6 distribution and three level disc disruption sat the c5 though t1 level.X-rays showed good positioning of instrumentation with solid fusion throughout.On (b)(6) 2012, the patient presented with cervical disc displacement and underwent a left c6-7 cervical steroid injection.No patient complications were noted.On (b)(6) 2012, the patient presented with left side neck pain and numbness radiating into the left arm - onset several months prior.The patient underwent a cervical mr including 3d reformations, which demonstrated multilevel moderate to severe spinal cord compression without clear evidence of myelopathy and multilevel spondylosis with potential nerve root compression in exit foraminal which show severe or moderately severe stenosis.On (b)(6) 2012, the patient presented with cervical radiculitis and underwent a left c6-7 cervical steroid injection.No patient comp lications were noted.On (b)(6) 2012, the patient in a 5 week follow up from a left sided c6-7 crsi injection.The patient reported some relief with respect to their pain but was still having numbness and tingling radiating down the back of the left arm in the left thumb and forefinger.The patient had grip strength weakness.The patient also presented low back pain radiating down the bilateral legs, left > right.X-rays showed solid appearing fusions and mild to moderate stenosis at l5-s1.Medications: roxicodone and zanaflex.Duexis was started.On (b)(6) 2013, the patient presented with chronic cervical and lumbar issues.X-rays showed solid appearing fusions at l3-4 and l4-5.The patient had adjacent segment disease above and below the fusions levels.Medications: roxicodone and zanaflex.The patient had been placed on duexis ¿ however the patient reported it did not work.The patient was given a pain management referral.On (b)(6) 2013, the patient presented with chronic continuous neck, low back pain, and left upper extremity pain.The patient had documented three level disc disruption of the cervical spine.Per the encounter notes that patient had previously good relief with injections on the left side c6-7.On (b)(6) 2013, the patient presented with chronic neck and low back pain.The patient had multilevel disc disruption in the cervical spine; subjective esthesias in the upper extremities and some weakness in the hands.Diagnosis: lumbar post laminectomy syndrome.Medications: roxicodone, tylenol, ibuprofen, and zanaflex.The patient underwent a drug screen.

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.

• 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: 4231533
• MDR Text Key: 5069306
• Report Number: 1030489-2014-04248
• 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
• Report Date: 10/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2014
• Device Catalogue Number: 7510400
• Device Lot Number: M111063AAN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2011
• 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): Required Intervention
• Patient Weight: 139