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

Catalog Number 7510100

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

Patient Problems Scarring (2061); Stenosis (2263); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on: (b)(6) 2009 , the patient underwent mri of lumbar spine which showed disc herniation at l5-s1.(b)(6) 2010 - the patient presented with preoperative diagnosis: lumbar disc herniation, l5-s1 right.She underwent following procedures: epidurogram; right s1 transforaminal epidural steroid injection.(b)(6) 2010, patient presented for follow up of her pain and preoperative evaluation before her surgery.She complaint of pain radiating from her neck down into that arm in an indistinct distribution.(b)(6) 2010, the patient presented with following preoperative diagnosis: l5-s1 spondylolysis with radiculopathy.She underwent following procedures: right-sided l5-s1 gill's type decompression for transforaminal lumbar interbody fusion using morselized autograft and peek cage with rh-bmp2/acs percutaneous pedicle screw stabilization using the pedicle screw system bilaterally.Emg monitoring using the nim-spine neuromonitor.Microscopic dissection.Fluoroscopy.Per op notes, a free floating lamina was noticed.Using the drill, a complete right l5 hemilaminectomy was done with a complete medial facetectomy and removal of the fractured pars area.This was morsellized for use as autograft.Once this was done, ligamentum flavum was removed to identify the l5 and s1 nerve root.The l5 nerve root takeoff was quite close to the s1 and the surgeon proceeded with identifying and protecting both nerve roots.The disk space was identified.The disk space was prepared until a 14 mm dilator was used.Once this was done, the disk space was irrigated and autograft was packed anteriorly medially followed by tamping in a 14 x 22 mm cage packed with rh-bmp2/acs presoaked for almost 1 hour.Once both the l5 and s1 nerve roots were decompressed on the right side, hemostasis was done with floseal.Some thrombin was also placed.The tube was removed at this point and i proceeded with placing the percutaneous pedicle screws.Using ap/lateral fluoroscopy, the bull's eye technique was used, cannulating the midpoint of the pedicle at l5 and 31 with no abnormal emg stimulation.Cannulated taps were used followed by placement of the screw.At the l5, a 6.5 x 40 mm screw was placed.At the s1., 7.5 x 35 mm screws were placed.All screws were placed without any complications or abnormal stimulation.On the right side, a 40 10m lordotic rod was used and on the left, a 45 mm lordotic rod was used.All screws and rods were placed and final tightening under compression.(b)(6) 2010, patient presented for post operative follow up.She complaint of numbness into her right foot.Impression: stable post operative course status post transforaminal lumbar interbody fusion.(b)(6) 2010, patient presented with complaint of pain and follow up.(b)(6) 2010, the patient presented for evaluation of her pain condition.She was examined and imaging results were reviewed.(b)(6) 2011, the patient presented for evaluation of her surgery.She denies any significant improvement in her condition.She underwent x rays examination: lumbar spinal x-rays showed pedicle screw fixation in place with interbody fusion at l5-s i.There is a trace spondylolisthesis at l5-s1.(b)(6) 2011, the patient presented for mri evaluation.(b)(6) 2011 <(>&<)> (b)(6) 2011 <(>&<)> (b)(6) 2011 , patient underwent mri scan of lumbar spine.(b)(6) 2012 , the patient presented for xray of thoracic spine.She had a history of back pain.(b)(6) 2012, the patient presented for evaluation of her condition.She underwent mri assessment and physical evaluation.(b)(4) 2012 mri- abnormal signal within the right lateral recess/medial right foramen at l5-s1 with mild to moderate mass effect on the right l5 nerve root.This is suspicious for postsurgical fibrosis given the enhancement.The differential would also include an extruded disc fragment.(b)(6) 2012, the patient presented with back pain and underwent examination and medicine refill.Impression: acute on chronic back pain with right greater than left leg pain likely consistent with irritative radiculitis with no evidence of nerve impingement.(b)(6) 2012 ct- at l5-s1, soft tissue density in the right lateral recess/medial foramen correlate with the abnormality seen on the mri on (b)(6) 2012.There is mild right foraminal stenosis.(b)(6) 2012 diagnostic studies: "i did get a ct scan done at providence which was pushed over, <(>&<)> i had a chance to review it.Overall the mri shows no evidence of spinal stenosis or nerve impingement.One s1 screw is broken, but alignment is still relatively well maintained.The cage remains in good position.On the ct actually there is fusion forming around the cage.I am not fearful that this will move." (b)(6) 2012, the patient presented for evaluation of his pseudoarthrosis at l5-s1.She is experiencing pain, difficulty in swallowing, leg and foot swelling, snoring, dizziness.Ct scan were reviewed which demonstrate a fractured screw as well as a pseudoarthrosis at l5-s1 with persistent right foraminal compression.(b)(6) 2012 - op report , patient was presented with preoperative diagnosis: l5-s1 pseudoarthrosis.She underwent following procedure:- hardware removal, removal of previous instrumentation l5-s1.L5-s1 laminectomy and decompression with bilateral facetectomies.L5-s1 posterior interbody arthrodesis.Posterior instrumentation l5-s1 with solera system.Placement of left interbody peek spacer.Morselized autograft harvested through the same incision.Interpretation of intraoperative fluoroscopy.Right l4-l5 posterior microforaminotomy.As reported ,both s1 screws had fractured at the base of the tulip.The previous instrumentation was removed.The screw shanks surgeons were able to extract from the s1 sacrum.New screws were then placed at l5 directed in a more lateral approach, although the facets were significantly disrupted by the previous hardware.New screws were also placed at s1.These were attached with rods.Working around the right l5 nerve root, this was fully decompressed within the foramen.Due to scarring, we were unable to really mobilize it enough to potentially consider removing the previous placed spacer.Over on the left side, we were able to mobilize the nerve root nicely and gain access to the disk space.The disk was then incised and removed with pituitary rongeurs and curettes removing all cartilaginous material from this aspect of the disk space and endplates.Attempts were made to remove the previous interbody spacer but this was not possible.The central portion of the disk space was then packed with morsellized autograft which was harvested through the same incision and then an expandable cage was then placed and expanded to its full size and then packed with additional bone.This completed the interbody fusion.The screws were compressed across the disk space and all nuts were then torqued to the appropriate tightness.Hemostasis was obtained (b)(6) 2012, the patient was here for staple removal.She was also refilled for medicines.(b)(6) 2012, patient presented for follow up.X rays was conducted.Impression: stable appearance status post fusion across l5-s1.(b)(6) 2013, the patient presented for follow up for l5-s1 redo fusion.She was then 3 months status post her l5-1 refusion and decompression.(b)(6) 2013.The patient presented for diagnostic radiology status postlumbar fusion.X-ray was performed.(b)(6) 2014 mri- l5-s1: there is soft tissue fullness suggested about the right paracentral/medial foraminal margins, presumed to correlate with a bar of bridging osteophytosis or calcification.This appears to again result in more pronounced narrowing of the right neural foramen inferiorly where the exiting l5 nerve root appears partially compressed.

• 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: 5149173
• MDR Text Key: 28244551
• Report Number: 1030489-2015-02674
• 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
• Report Date: 09/21/2015

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: 11/30/2010
• Device Catalogue Number: 7510100
• Device Lot Number: M110910AAH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/17/2010
• 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
• Patient Weight: 106