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 Loss of Range of Motion (2032); Urinary Retention (2119); Weakness (2145); Tingling (2171); Stenosis (2263); Discomfort (2330); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4): neither device nor applicable imaging studies returned to manufacturer for evaluation.

Event Description

It was reported that (b)(6) 2004: the patient underwent mri of lumbar spine without contrast.Impression: large right paracentral disc herniation at l5-s1 compressing the thecal sac and right s1 nerve root.Moderate disc bulge l2-3.Mild diffuse disc bulge l3-4 and l4-5.(b)(6) 2004: the patient presented for an office visit.He had an impressive l5-s1 posterolateral disc herniation towards the right, occupying much of the spinal canal volume.Medication was changed from naproxen to celebrex.His lumbar mri films were reviewed.He had a large rightward posterolateral disc herniation to the right at l5-s1, occupying most of the spinal canal and obliterating the s1 foramen.There was a small mid/right paramidline disc bulge at l2-3 that did not appear to be causing any neural compression.Impression: right leg pain with minimal low back pain suggesting lumbar radiculopathy.There was an associated very large rightward posterolateral ls-s i disc herniation.(b)(6) 2011: the patient presented with following pre-op diagnosis: lumbar radiculopathy.The patient underwent the following procedure: right l5-s1 translaminar epidural steroid injection.The procedure was well tolerated and without complication.(b)(6) 2004: the patient presented with presents with a four month history of right buttock and lower extremity pain radiating into the foot associated with numbness.Mri was reviewed and demonstrated a large right-sided l5-s1 disc extrusion which displaced the s1 nerve root.Impression: s1 radiculopathy.(b)(6) 2004: the patient presented with following preoperative diagnosis: lumbar radiculopathy.The patient underwent right l5-s1 he milaminotomy, partial medial facetectomy, partial diskectomy.No patient complications were reported.(b)(6) 2004: the patient presented 2 weeks status post lumbar discectomy for follow up.(b)(6) 2009: the patient underwent mri of lumbar spine.Impression; multilevel degenerative changes with disc protrusions at l4-5 and l5-s1.(b)(6) 2010: the patient presented for pain consultation.Summary: degenerated disk with mild concordant pain response at l2-3, normal disk at l3-4, degenerated disk with moderate to severe concordant pain response at l4-5, indeterminate disk at l5-s1.(b)(6) 2010: the patient presented for an office visit.The patient had concordance at l2-3, l4-5 and l5-s1 was indeterminate.L5-s1 was reported to be the worst.Assessment: lumbago.(b)(6) 2010: the patient presented for functional capacity evaluation.The patient complained of pain across the lumbosacral region that was worse on the left than the right.The pain radiated down to the gluteal regions.He got lower extremity pain on the left worse than the right.He described in the left lower extremity having numbness, pins and needles, and burning mainly in the back of the thigh, and occasionally extends below the knee.He had some symptoms in the right lower extremity.Those had been more recent, but were much less than the left side.Tenderness was noted at the left 'psis' region, and diffusely in the left lumbosacral region.Therapy problems included: diminished lumbar rom.The client is obese.Client noted symptoms across the low back, left greater than right, with most activities, as well as some complaints into the left lateral thigh, though not distal to the knee joint with material handling/positional tolerances.Length of time client has been in the patient mode.Deconditioned and decreased activity levels.Continued pain complaints.Concerns with returning to full duty and dealing with the pain.(b)(6) 2010: the patient presented with back pain due to injuries sustained at work.Impression: degenerative disc disease and probable discogenic back pain.(b)(6) 2011: the patient presented for an office visit due to continued back and leg pain.(b)(6) 2011: the patient presented with back and bilateral lower extremity pain.The pain continued to be a sharp soreness in his back down both legs, left worse than right.It was better with the use of hydrocodone.It was worse with prolonged sitting, standing, walking, or lifting.Impression: lumbar degenerative disk disease.Diagnostic studies: mri scan showed degenerative changes at l4-ls and l5-s1.In the diskogram procedure, he had a positive level at l4-l5, indeterminate l5-s1 because of inadequate needle positioning to the center of the disks.It was likely though that l5-s1 was also contributor to his pain.(b)(6) 2011: the patient presented for cardiac clearance for back surgery.Review of systems revealed back pain, numbness of legs.Impression: coronary artery disease, status post coronary artery stenting x3 in 2005.Secondary pulmonary hypertension.History of chronic kidney disease with microalbuminuria.Hyperlipidemia.Hypertension.Obesity.Preop status back surgery for lumbar radiculopathy.Obstructive sleep apnea.(b)(6) 2011: the patient presented for an office visit.Assessment: chronic kidney disease with history for membranous glomerulonephritis and microalbuminuria.He has a history of hypertension.Chronic back pain with scheduled back surgery in the near future.(b)(6) 2011: the patient presented with following preoperative diagnosis: lumbar disk disease, lumbar spinal radiculopathy.The patient underwent the following procedure: l4-l5 and l5-s1 minimally invasive transforamional lumbar interbody fusion with viper and pipeline using allograft bone and bone morphogenic protein.Per op-note, under fluoroscopic guidance, allograft bone was packed into the disk space of l4-l5, which had been decorticated.Healos was packed with bmp.The cage was packed.Concord cage was inserted, countersinking it anterior to the posterior body line.Excellent position of the implant was noted.This was then repeated in similar fashion at the l5-s1 level.Following implants were used apart from rhbmp-2/acs: cancellous crushed 1-4 mm 15 cc, bone graft substitute x2.There were no patient complications.(b)(6) 2011: the patient underwent post-op diagnostic radiological study of lumbar spine.Conclusion: postoperative changes of posterior stabilization at l4-l5 and l5-s1.(b)(6) 2011: the patient underwent mri of lumbar spine.Indication: surgery one day ago.Bilateral numbness tolegs.Extreme low back pain.Impression: no abscess or epidural hematoma identified.Unusual appearance of the contents of the thecal sac.This could indicate arachnoiditis/inflammation or perhaps a small amount of hemorrhage within the thecal sac.Some of this appearance may be attributable to the overall narrowing of the thecal sac diameter from epidural adipose tissue.(b)(6) 2011: the patient underwent mri of the cervical spine.Patient had history of numbness in bilateral legs.Impression: no significant spinal canal stenosis of the cervical spine.(b)(6) 2011: the patient was transferred for care regarding postoperative urinary retention.He stated he got up once or twice at night due to void; denied urinary frequency, urgency, urge incontinence, dysuria, gross hematuria.He complained of numbness and tingling in his lower extremities, weakness, inability to ambulate as well as, denied having a bowel movement.Review of systems is as follows: musculoskeletal: he complained of back pain.Neurologic: numbness or tingling to his lower extremities.Psychiatric: history of anxiety.Assessment: postoperative urinary retention.(b)(6) 2011: the patient was discharged and then readmitted with following diagnosis: status post spinal fusion.The patient was undergoing postoperative convalescence (b)(6) 2011: the patient was discharged in good condition.(b)(6) 2011: the patient presented for post-op follow up.He noted that he had a little bit of pain towards the left side.The back pain was greatly different from what he was experiencing prior to the operation.(b)(6) 2011: the patient presented status post mis tlif.He had a little bit of numbness in the leg, he but otherwise he indicated that he had been getting along quite nicely.X-rays: he had radiographs, which demonstrated he appeared to be developing some fusion, at this point in time, in the interspace, early on.Impression: status post spinal fusion.(b)(6) 2011, (b)(6) 2012: the patient presented for physical therapy.Therapy problems: low back and left radicular complaints greater than right.Decreased activity level.Decreased trunk rom in all planes; 3+ to 4/5 muscle grades in the left lower extremity.Decreased tolerance to standing and walking over an hour, and sitting being uncomfortable.(b)(6) 2011: the patient presented status post tlif.The patient had some difficulty, mostly with the back pain.Radiographs demonstrated the implants are all well positioned.He appears to be healing nicely.Impression: status post spinal fusion.(b)(6) 2011: the patient presented for physical therapy evaluation.He stated that he got uncomfortable and noted being depressed.He had tried to walk, but stated that he caught his left foot dragging, stating it was "super numb" from the bottom of his left foot into his toes.He reported that his sleep was broken, and unable to sleep through the night.(b)(6) 2012: the patient presented status post tlif.Radiographs reviewed which demonstrated the implants are all well positioned.He appears to be healing nicely.Impression: status post spinal fusion.(b)(6) 2012: the patient presented six months out status post two-level tlif.He reported a bit of numbness yet in the foot on the left side.He had a little pain as well.(b)(6) 2012: the patient presented for an office visit.His radiographs demonstrated that he was developing a solid fusion in the interspace.Impression: status post spinal fusion.(b)(6) 2013: the patient underwent mri of lumbar spine with and without contrast due to lumbar radiculopathy.Impression: bilateral foraminal stenosis, l2-l3.Post-surgical changes of posterior spinal fusion of l4 to s1 with intervertebral disc spacers.Extensive degenerative disc disease and facet osteoarthropathy.

• 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: 4989566
• MDR Text Key: 22495239
• Report Number: 1030489-2015-01962
• 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: Other
• Report Date: 07/27/2015

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
• Device Expiration Date: 01/01/2014
• Device Catalogue Number: 7510600
• Device Lot Number: M111052AAE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/27/2011
• 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): Other
• Patient Weight: 151