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 Apnea (1720); Pain (1994); Urinary Retention (2119); Stenosis (2263); Anxiety (2328); Hypoesthesia (2352)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient underwent spine fusion surgery on vertebrae l5-s1.She was implanted with rhbmp-2/acs.Post surgery, she suffered from p progressively worsening low back and right leg pain.She underwent revision surgery due to severe pain and symptoms.

Manufacturer Narrative

(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on: (b)(6) 2009: patient presented with following pre-op diagnosis: l5-s1 lateral recess stenosis, foraminal stenosis and radiculopathy.L5-s1 degenerative disc disease and collapse with severe low back pain.Procedure: l5-s1 facetectomy, foraminotomy, lateral recess and foraminal decompression.L5-s1 tlif with capstone implant, autograft and bmp.L5-s1 posterolateral fusion with autograft bmp and graft putty.L5-s1 pedicle screw instrumentation with 3-d system screws.Harvest of local bone graft.Stealth stereotactic intraoperative navigation.Intra-op findings: very tight lateral recess stenosis on the left and severe right l5 foramiinal stenosis.Complete and thorough decompression was accomplished.Per op notes: bmp was placed over the transverse process and placed graft putty over the bmp sponge.A 8 x 26 cage /implant was used.On (b)(6) 2009: patient underwent x-ray of lumbar spine 2 views.Impression: prosthesis in the l5 interspace, scattered air levels wit hin bowel loops in the abdomen and pelvis including some upper limits of normal small bowel loops in the lower abdomen consistent with an ileus.Moderate degenerative and hypertrophic changes seen in the spine with narrowing of the l5, l3, l2 and l1 interspaces.On (b)(6) 2009: patient presented with following assessment: satisfactory appearance of lumbar incision, greater trochangeric bursitis bilaterally, mild hypesthesia of the left lateral foot.On (b)(6) 2009: patient presented with following assessment: satisfactory radiographic appearance of fusion construct, mild low back pain, continued resolution of right lower extremity pain.On (b)(6) 2009: patient presented with following assessment: apparent solid fusion at l5-s1, continued mild hypesthesia of the left lateral foot, continued resolution of right lower extremity pain.Lumbar spine two views impression: lumbosacral fusion without abnormal alignment.On (b)(6) 2012, (b)(6) 2013, (b)(6) 2012, (b)(6) 2013, (b)(6) 2012, (b)(6) 2013, (b)(6) 2014: patient presented for office visit due to low back pain.On (b)(6) 2012: patient presented with following pre-op diagnoses: right l3-4 lumbar intraforaminal far lateral herniated disk with right l3 radiculopathy.L2-3 lumbar spinal stenosis.Procedure: l3-4 laminectomy and right lumbar transfacet resection of intraforaminal far lateral disk with decompression of right l3 nerve root.L2-3 decompressive laminectomy with central and lateral recess decompression.On (b)(6) 2013: patient presented with sleep apnea, shortness of breath, trouble swallowing, joint pain, urinary frequency, urinary retention, depression, anxiety.On (b)(6) 2013: patient presented with following impression: electrodiagnostic evidence of an acute right l3 radiculopathy, but less likely, l4.On (b)(6) 2013: patient underwent ct of lumbar spine.Impression: solid anterior and posterior fusion at l5-s1, bilateral pars defects at l3 with advanced degenerative disc disease and facet osteoarthritis at l3-4.Multilevel degenerative changes with neural foraminal and central canal stenosis most pronounced at l3-4.Patient underwent lumbar puncture for myelography using fluoroscopic guidance.

• 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: 5079796
• MDR Text Key: 25877194
• Report Number: 1030489-2015-02376
• 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,Followup
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2011
• Device Catalogue Number: 7510400
• Device Lot Number: M110803AAO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/21/2009
• 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: 88