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 Chest Pain (1776); Fainting (1847); Fall (1848); Muscle Weakness (1967); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Neither device nor applicable imaging studies returned to manufacturer for evaluation.

Event Description

It was reported that on (b)(6) 2007 the patient underwent mri of lumbar spine.Impressions: minimal bulging of the disc material at l4-5 bilaterally.The central canal was also widely patent at the ia-5 level on (b)(6) 2008 the patient was admitted to the hospital for surgery.Admission diagnosis: failed l5-s1 fusion with fracture of all four pedicle screws.Preoperative diagnosis: failed l5-sl fusion with fracture of pedicle screws at l5 bilaterally and fracture of pedicle screws at s1 bilaterally.Procedures performed: lumbar re-exploration for explanation of pedicle screws bilaterally at l5 and s1 including the extraction of a broken fragment of pedicle screw within the body of ls bilaterally and resection of a fractured pedicle screw within the body of s1 bilaterally.Revision fusion of ls-s1 using pedicle screw instrumentation and autograft and rh-bmp2/acs.Right ls-s1 transforaminal lumbar interbody fusion using polyether ether ketone interbody implant and local autograft and rh-bmp2/acs.Right posterior iliac crest autologous bone graft harvest.A retractor was placed.All four set screws were then removed from the previously placed pedicle screws, and that this instrumentation had fractured was quite evident even at this point in the case.The rods were removed, and then the fractured remnants of the pedicle screws were also removed using the extraction set and also the extraction set provided by ebi.Then removed the remnants of the pedicle screws within the pedicles at l5 bilaterally and at s1 bilaterally.This was achieved by using a reverse trephine initially measuring 7.5 mm and then a reverse trephine measuring 6.5 mm.I then used a reverse backout instrument to remove the remnant of the pedicle screws.This was done first at s1 on the right, then l5 on the right, then s1 on the left, then l5 on the left.After each of the pedicle screw remnants was removed, i then used a 90-degree ball-tip dissector and probed the pedicles and found no breach.A 15-blade was then used to incise the posterior longitudinal ligament in a rectangular fashion, and then the entire disc at 15-81 was removed using a combination of a pituitary rongeur, paddle scrapers, down-biting curets, side-biting curets, and the serrated, angulated, side-biting curets and the serrated, straight, side-biting curets.Then endplates were removed and partial decortication of the bony endplates was done.Then attention was turned to iliac crest autograft harvest.The iliac crest was palpated, and the bovie was then used to elevate the fascia so as to expose only the outer table of the ileum.A retractor was used to maintain retraction, and then an osteotome was used to make a window of the outer cortical bone down to a depth of 3 mm.Gouges were then used to remove all available underlying cancellous bone.The inner table was inspected and no breach had occurred.The wound was irrigated.The bone putty was then used to reconstitute the iliac crest on the right after the harvest.The cancellous autograft bone was then wrapped using four of the rh-bmp2/acs-soaked sponges.One of these sponges was then cut in half with scissors, and used to fill a 14-mm polyether ether ketone interbody implant.Two additional rh-bmp2/acs/autograft rolls were placed into the disc space at l5-sl, one being placed medially and one laterally.Under fluoroscopic guidance.The 14-mm polyether ether ketone implant was then put into position and tamped into place again under fluoroscopic guidance.The fourth rh-bmp2/acs/autograft roll was then placed dorsal to this implant.The woodson-adson was used to explore the foramen and the epidural space, and used to ensure that there was no evidence of ongoing compression of the thecal sac or the exiting l5 root or the traversing s1 root by the graft material.After the pedicle screws were placed, the last two remaining rh-bmp2/acs-soaked sponges were placed overlying the posterolateral space, and then the remaining autograft was also divided into two and packed into the drilled defects of the posterolateral fusion mass, as well.A 40-mm rod was placed bilaterally within the heads of the pedicle screws, and the patient was then taken out of flexion.Set screws were then placed at l5 on the right, at s1 on the right, then l5 on the left.On (b)(6) 2008 the patient was discharged in stable condition.On (b)(6) 2008 the patient was presented for follow up office visit.The patient underwent xrays of lumbar spine.No complications were reported.On (b)(6) 2008 the patient was presented for follow up office visit.She continues to experience the majority of her pain in the early morning hours, but by mid afternoon, she is able to ambulate fairly easily without significant discomfort.Medications were monitored.On (b)(6) 2008 the patient underwent ct scan of lumbar spine.Impressions: the presence of a solid fusion in the posterolateral space bilaterally at l5-s1, as desired.There appears also to be a fusion developing in the interbody space at ls-s1.The l5 foramina do appear widely patent on the ct images bone windows.The pedicle screw placement is as desired bilaterally at the l5 and s1 levels, the interbody graft remains in good position as wen, and again a solid fusion docs appeal' to have formed surrounding it.On (b)(6) 2008 the patient was presented for follow up office visit.She did experience last week transient right leg numbness, but this resolved within an hour or so.On (b)(6) 2009 the patient underwent xrays of the elbow due to elbow pain.No complication was reported.The patient also underwent xrays of lumbosacral spine due to ground level fall by fainting.No complication was reported.On (b)(6) 2010 the patient was presented for office visit with back pain right leg pain.The pain has alleviated.The paresthesias were localized to the right anterior leg in a nonspecific distribution.Review of systems: neurologic- muscular weakness; psychiatric- depression.Assessment: spondylosis, lumbar; postlaminectomy syndrome of lumbar region.On (b)(6) 2010 the patient underwent mri of the lumbar spine.Impressions: lumbar fusion at ls-s1.Mild bilateral foraminal stenosis at l4-5.On (b)(6) 2010 the patient was presented for office visit with back pain.Assessment: degeneration of lumbosacral intervertebral disc; lumbar pain syndrome.On (b)(6) 2010 the patient underwent mri of the pelvis due to pelvic pain and right hip pain.Impressions: lumbar fusion at ls-sl.Mild bilateral foramina 1 stenosis at l4-5.On (b)(6) 2010 the patient underwent xrays of the chest due to chest pain.No complication was reported.On (b)(6) 2010 the patient was presented for office visit with back pain.Most of the pain was in the neck and low back.Assessment: spondylosis, lumbar.On (b)(6) 2011 the patient underwent mri of lumbar spine.Impressions: l5-s1 isthmic spondylolisthesis without foraminal stenosis.On (b)(6) 2011 the patient underwent xrays of the abdomen and chest due to abdominal pain.No complications was reported.On (b)(6) 2011 the patient underwent xrays.Impressions: postoperative changes of l5-s1 posterior fusion.On (b)(6) 2011 the patient was presented for office visit with back pain.Assessment: spondylolisthesis, lumbar.On (b)(6) 2012 the patient underwent mri of lumbar spine.Impressions: ls-s1: anterior fusion with intact orif without restenosis.On (b)(6) 2012 the patient underwent xrays of right hand due to right thumb pain and right hand pain.No complication was reported.On (b)(6) 2012 the patient was presented for xrays of lumbosacral spine.Impressions: questionable fracture involving on of the lower s1 fixation screws.Postsurgical change from spinal decompression, would consider follow up lateral flexion and extension views to assess for pseudarthrosis.Recoment on a high- resolution ct scan using a 64 slice or larger scanner to evaluation of fixation hardware and exclude fractured screws at s1.The patient also underwent mri of the brain due to right-sided weakness, stroke.Impressions: minimal subcortical white matter changes with no evidence for acute ischemia.This either represents early microvascular changes or possibly a demyelinating process, although this appearance is not typical for multiple sclerosis.On (b)(6) 2012 the patient was presented for office visit with back pain and depression.Pain radiated from back into groin and also down posterior thighs.Impressions: spondylolisthesis, lumbar.On (b)(6) 2012 the patient underwent ct scan of the abdomen and pelvis due to low abdominal pain, low back pain.No complication was reported.On (b)(6) 2012 the patient underwent xrays of pelvis and both hips.Impressions: degenerative change s1 joints and the lumbar spine.On (b)(6) 2012 the patient underwent xrays of chest due to cough.No complications were reported.On (b)(6) 2013 the patient underwent ct scan of abdomen and pelvis.Impressions: no acute findings in the abdomen or pelvis.No distal stones or obstruction.Possible fibroid uterus.If of clinical concern could correlate with pelvic ultrasound.On (b)(6) 2013 the patient underwent mri of the lumbar spine due to low back pain.Impressions: postoperative changes of lumbosacral fusion.Shallow posterior l1-2 disc protrusion.On (b)(6) 2013 the patient underwent ct scan of lumbar spine due to low back pain and bilateral lower extremity pain.On (b)(6) 2013, (b)(6) 2013 the patient underwent xray of chest due to coughing.No complications were reported.Impressions: shallow posterior left paracentral t12-l1 disc protrusion.Post-operative changes of posterior l5-s1 fusion.On (b)(6) 2014 the patient underwent xrays of lumbosacral spine due to low back pain and multiple surgeries.Impressions: postoperative changes of l5-s1 with a grade ii spondylolisthesis at this lever.Very mild degenerative spondylosis at other levels.

• 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: 5059814
• MDR Text Key: 25110338
• Report Number: 1030489-2015-02238
• 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: 08/17/2015

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: 03/01/2010
• Device Catalogue Number: 7510600
• Device Lot Number: M110610AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/03/2007
• 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