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

Catalog Number 7510800

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

Patient Problems Calcium Deposits/Calcification (1758); Cyst(s) (1800); Edema (1820); High Blood Pressure/ Hypertension (1908); Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Swelling (2091); Tingling (2171); Injury (2348); Numbness (2415); Sleep Dysfunction (2517)

Event Type  Injury  

Event Description

It was reported that the patient underwent a spinal fusion procedure at l5 to s1 using rhbmp-2/acs on (b)(6) 2008.Patient's post-operative period has been marked by severe low back pain, with associated numbness, tingling and pain in his lower extremities.A lumbar ct scan performed on (b)(6) 2009, revealed a calcified cyst impinging on the exiting nerve root.Patient underwent a revision surgery on (b)(6) 2009 at the l5-s1 level.A post-revision mri scan performed on (b)(6) 2010, revealed recurrence of the cystic changes at the implant site.Patient continues to experience severe and unrelenting pain in his lower back with radiation into his lower extremities.His sleep and work have been adversely affected due to pain.

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.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2008 the patient underwent the following surgeries: right l5-s1 laminectomy with facetectomy and foraminotomy (transforaminal approach) right l5-s1 diskectomy; tlif at l5-s1 approached from the right side, the spacer was a 13 mm synthes tlif peek spacer at l5-s1; posterolateral fusion l5-s1; with auto graft and allograft; rhbmp-2/acs; intraoperative fluoroscopy; percutaneous cannulated l5-s1 synthes pedicle screws and rods (6.5 mm x 45 at l5 and 35 mm at s1); intraoperative emg and ssep monitoring to treat the following pre-op diagnosis: low back pain with right lower extremity radiculopathy consisting mainly of pain, mri scan shows a large central disc herniation at l5-s1 slightly more preferential towards the right side.The patient denies any left lower extremity symptoms.Per operative notes: ¿¿once this was done the distractor was again used to apply the auto and allograft matrix which included the use of rhbmp-2/acs and bone graft.After this, the 13 mm synthes peek tlif spacers were placed with the approach being from the right side.A posterolateral fusion was then performed auto/allograft mixtures incorporating rhbmp-2/acs, bone graft and autograft for a posterolateral fusion.Patient was in a satisfactory condition.There were no complications.Neuromonitoring was stable throughout the case.On (b)(6) 2009 patient underwent the following procedures: removal of pedicle screws and rods at l5-s1 to treat the following pre-op diagnosis: neuropathic pain related to pedicle screws and rods, low back pain with right lower extremity radiculopathy consisting mainly of pain.Resolved status post l5-s1 tlif, mri scan shows a large central disc herniation at l5-s1 slightly more preferential towards the right side.The patient denies any left lower extremity symptoms.Right l5-s1 laminectomy with facetectomy and foraminotomy (transforaminal approach); right l5-s1 diskectomy; tlif at l5-s1 approached from the right side, the spacer was a 13 mm synthes tlif peek spacer at l5-s1; posterolateral fusion l5-s1; with autograft and allograft; rhbmp-2/acs; intraoperative fluoroscopy; percutaneous cannulated l5-s1 synthes pedicle screws and rods (635 mm x 45 mm at l5 and 35 mm at s1); intraoperative emg and ssep monitoring.On (b)(6) 2009 patient presented for an office visit due to: neuropathic pain related to pedicle screws and rods, low back pain with right lower extremity radiculopathy consisting mainly of pain.Resolved status post l5-s1 tlif, mri scan shows a large disc herniated at l5-s1 slightly more preferential towards the right side.The patient denies any left lower extremity symptoms, right l5-s1 diskectomy; tlif at l5-s1 approached from the right side, the spacer was a 13 mm synthesis tlif peek spacer at l5-s1; posterolateral fusion l5-s1; with autograft and allograft; rhbmp-2/acs; intraoperative fluoroscopy; percutaneous cannulated l5-s1 synthes pedicle screws and rods fluoroscopy; percutaneous cannulated l5-s1 syntheses pedicle screws and rods (6.5 mm x 45 mm at l5 and 35 at s1); intraoperative emg and ssep monitoring (14 aug 2008), removal of pedicle screws and rods at l5-s1 ((b)(6) 2009).On (b)(6) 2008, (b)(6) 2009 patient presented for an office visit due to: low back pain with right lower extremity radiculopathy consisting mainly of pain.Mri scan shows a large disc herniated at l5-s1 slightly more preferential towards the right side.The patient denies any left lower extremity symptoms, right l5-s1 diskectomy; tlif at l5-s1 approached from the right side, the spacer was a 13 mm synthesis tlif peek spacer at l5-s1; posterolateral fusion l5-s1; with autograft and allograft; rhbmp-2/acs; intraoperative fluoroscopy; percutaneous cannulated l5-s1 synthes pedicle screws and rods fluoroscopy; percutaneous cannulated l5-s1 syntheses pedicle screws and rods (6.5 mm x 45 mm at l5 and 35 at s1); intraoperative emg and ssep monitoring ((b)(6) 2008).On (b)(6) 2008, (b)(6) 2009 patient presented for an office visit due to pain and med refill.On (b)(6) 2009 patient underwent ct of lumbar spine without contrast.Impression: there was a low density region extending from posterior l5-s1 disc space into the right lateral recess and medial right neural foramen.This demonstrates a thin rim of calcification and demonstrates some interval expansion of the posterior l5-s1 disc space and right neural foramen.This was of uncertain etiology and considerations would include an inflammatory response such as exuberant tissue.Correlation with a contrast-enhanced mri of the lumbar spine was recommended , with the understanding that there will be some artifact related to the transpedicle screws.On (b)(6) 2009 patient underwent mri of lumbar spine due to back pain.Central herniation of the disc at l5-s1 with encroachment upon the lateral recesses bilaterally.The herniation was touching and slightly displacing the thecal sac, examination was otherwise negative.On (b)(6) 2009 patient underwent ct of lumbar spine without contrast.Impression: attempted fusion at l5-s1 with intact hardware.There was evidence of some incorporation of the interbody graft material, 2.26 cm soft tissue opacity at the posterior margin of the interbody graft material at l5-s1 with thin rim of calcification and extension of soft tissue opacity into the right lateral recess and right neural foramen at l5-s1.This was also described on the prior study and has not significantly changed.This may represent epidural granulation tissue though further evaluation with mri with and without contrast should be considered, no acute fracture.On (b)(6) 2009 patient presented for an office visit due to pain meds and low back pain.On (b)(6) 2009 patient presented for an office visit due to low back pain and medication refill.On (b)(6) 2009 patient presented for follow-up on lumbar fusion l5-s1 done (b)(6) 2008, rod and screws removed.On (b)(6) 2009, (b)(6) 2010 patient presented for an office visit due to medication refill and low back pain.On (b)(6) 2009 patient presented for an office visit due history of numbness, tingling and pain in both of his feet and legs.On (b)(6) 2010 patient underwent xr of l-spine 2/3 views.Impression: normal alignment, postoperative changes in the lumbosacral junction, bone graft seen posteriorly with intervertebral spacer at the l5-s1 disc space level.On (b)(6) 2010 patient presented for an office visit due to medication refill.On (b)(6) 2010 patient underwent an x-ray due to mild lumbar facet arthropathy, no lumbar central canal stenosis.Patient underwent mri of lumbar spine without and with contrast.Patient underwent mri of lumbar spine without and with iv contrast.On (b)(6) 2010 patient presented for an office visit due to low back pain.On (b)(6) 2010 patient presented for an office visit due to medication refill.On (b)(6) 2010 patient presented for an office visit due to chronic ¿ibp¿.On (b)(6) 2010 patient presented for an office visit due to pain level 9, having severe sharp pain right side.On (b)(6) 2010 patient underwent ct scan of lumbar spine ¿wo¿.Impression: recent posterior column discectomy and fusion procedure l5-s1 with instrumentation projecting in expected location.Normal lumbar lordosis without scoliosis or spondylolisthesis.No acute fracture or acute compression fracture identified.Posterior superficial and deep soft tissue edema/swelling with subcutaneous emphysema, none of which appears organized.On (b)(6) 2010 patient presented for an office visit.On (b)(6) 2010 patient presented for an office visit due to pain level was 7.On (b)(6) 2010 patient presented for an office visit due to injections, ¿diag¿/therapeutic, paravertebral facet joint/ nerve w image guidance, lumbar or sacral single level.On (b)(6) 2010 patient presented for an office visit due to failed back syndrome, recent right lumbar ¿mbb¿ done with no relief.On (b)(6) 2010 patient presented for an office visit due to medication refill.On (b)(6) 2010 patient presented for a follow up visit pain mostly right side pain level was 9.On (b)(6) 2010 patient presented for an office visit due to medication refill.On (b)(6) 2010 patient presented for a follow up visit pain level 6 ¿hx¿ of failed back syndrome.On (b)(6) 2011 patient presented for an office visit due to intervertebral disc disorders: lumbar region, spondylosis and allied disorders: lumbosacral spondylosis without myelopathy, other and unspecified disorders of back: thoracic or lumbosacral neuritis or radiculitis, unspecified.On (b)(6) 2011 patient underwent radiology of lumbar spine.Impression: previous spinal fusion at l5-s1 level with complete obliteration of l5-s1.Upper lumbar disc spacers are adequately maintained.No evidence of acute bony trauma detected.On (b)(6) 2011 patient presented for an office visit due to back pain.Impression: chronic low back pain, lumbar radiculopathy.On (b)(6) 2011 patient presented for an office visit due to back pain.On (b)(6) 2012 patient presented for an office visit due to back pain.Impression: chronic low back pain, lumbar radiculopathy and insomnia.On (b)(6) 2012 patient presented for an office visit due to back pain.Impression: insomnia, low back pain, lumbar radiculitis and muscle spasms.On (b)(6) 2012 patient presented for an office visit.On (b)(6) 2012 patient presented for an office visit due to back pain.Impression: lumbago, lumbosacral neurit.On (b)(6) 2012 patient presented for an office visit due to back pain.Impression: low back pain, lumbar radiculopathy and muscle spasm.On (b)(6) 2012 patient presented for an office visit due to back pain.Impression: low back pain, lumbar radiculopathy and hypertension.On (b)(6) 2013 patient presented for an office visit due to chronic back pain.Impression: low back pain, lumbar radiculopathy and muscle spasm.On (b)(6) 2013 patient presented for an office visit due to chronic back pain.Impression: low back pain, lumbar radiculopathy and muscle spasm.On (b)(6) 2013 patient presented for an office visit due to chronic back pain.Impression: low back pain, lumbar radiculopathy and muscle spasm.On (b)(6) 2013 patient presented for an office visit due to chronic back pain.Impression: low back pain, lumbar radiculopathy and muscle spasm.On (b)(6) 2013 patient presented for an office visit due to chronic back pain, memory loss.Impression: chronic low back pain, lumbar radiculopathy, muscle spasm and memory loss.

• 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: 3892504
• MDR Text Key: 14880137
• Report Number: 1030489-2014-02869
• 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: 04/28/2016

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: 08/01/2010
• Device Catalogue Number: 7510800
• Device Lot Number: M110708AAH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/30/2014
• Initial Date FDA Received: 06/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/06/2008
• 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: 66