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

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

Patient Problems Ossification (1428); Cerebrospinal Fluid Leakage (1772); Incontinence (1928); Nausea (1970); Pain (1994); Vomiting (2144); Numbness (2415)

Event Type  Injury  

Event Description

It was reported that the patient underwent a lumbar fusion procedure at l4 to l5 using rhbmp-2/acs on (b)(6) 2009.Patient's post-operative period has been followed by a temporary period of relief, but has subsequently been marked by increasingly severe low back pain, with radiation of pain and numbness into his lower extremities.A lumbar mri performed on (b)(6) 2010, revealed loss of disc height and irregular bone formation at the surgery level.On (b)(6) 2010, patient underwent a revision surgery to decompress his l5 nerve root.Following surgery, patient developed a dural defect with cerebrospinal fluid leak, causing him to suffer functional incapacity and nausea, vomiting, and positional headaches.This necessitated further surgery to repair the leak.Patient continues to experience severe and unrelenting low back pain with radiation into his lower extremities, and is unable to sit or stand for long periods.Additionally, following his surgery, the patient developed incontinence of bowel.

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: on (b)(6) 2009: the patient was pre-operatively diagnosed with status post left hemilaminectomy and partial discectomy at l4-l5.Recurrent disc herniation l4-l5, grade i spondylolisthesis l4-l5, severe degenerative disc disease of l4-l5 and underwent following procedures: revision, bilateral laminectomies and foraminotomies at l4-l5.Posterior lumbar interbody fusion at l4-l5 after complete discectomy use of interbody cage in interbody space at l4-l5.Use of local bone autograft, bone morphogenic protein product and graft compression-resistance matrix in the interbody space at l4-l5.Posterior spinal arthrodesis at l4-l5.Use of pedicle screw <(>&<)> rod system posterolaterally at l4-l5.Use of local bone autograft as well as bmp posterolaterally at l4-l5.As per op-notes¿ the surgeons were able to use our plif instruments consisting of straight and angled curettes with teeth on their ends, chisels, osteotomes and pituitary rongeurs to prepare the disc space.With these instruments, the surgeons were able not only to remove the entire disc, but also the articular cartilage off both end plates.When surgeons were satisfied, they passed a cube of graft compression-resistant matrix into the interbody space with bmp wrapped around it.This was followed by a significant amount of local bone autograft and then finally the appropriate sized cage.One piece of bmp had been placed in the central aspect of cage.The surgeons were able to now identify and expose the transverse processes of l4 and l5 bilaterally in a subperiosteal fashion.The surgeons decorticated all four transverse processes and inserted four pedicle screws.Each screw was inserted by first palpating the pedicle through the canal.Then they inserted an awl into the pedicle.The surgeons interlocked the screws on both sides with appropriate rods and set screws.The surgeons took an intraoperative x-ray, which confirmed that the correct level had been done and the hardware was in excellent position.The surgeons now packed bmp as well as a significant amount of local bone autograft over the decorticated over the decorticated bony elements in the lateral gutters on both sides.The surgeons noted a stable, solid construct in the end.The patient tolerated the procedure without any complications and was taken to recovery room in stable condition¿.The patient also underwent x-ray of lumbar spine intraoperative.Impression: the first lateral image shows a metallic surgical instrument projecting over the l4 spinous process.The second lateral image shows posterior fusion of l4 and l5 with prosthetic disc at the l4-l5 level.On (b)(6) 2009: the patient presented post a lumbar revision laminectomy at l4-l5 and posterior interbody fusion as well as posterior fusion with rods, screws and local bone autograft.On (b)(6) 2009: the patient presented for follow up for back pain.On (b)(6) 2009: the patient presented a chief complaint of back pain.The patient complained of a lot of axial pain and a little bit of pain running down his legs.On (b)(6) 2009: the patient presented to determine the efficacy of his pain medication on his left back pain.The patient complained of that dull sharp, stabbing pain that radiates, but it was just right sciatica with some positive paresthesia.Assessment: lumbar radiculopathy.On (b)(6) 2010: the patient presented with pain and numbness in his leg.On (b)(6) 2010: the patient presented to determine the efficacy of his pain medication on his left back pain.On (b)(6) 2010: the patient underwent mri of lumbar with or without contrast due to low back pain, left leg pain.Conclusion: evidence of l4-l5 posterior instrumentation.The spinal canal is patent with no definite recurrent disc herniation or significant alignment abnormality.Mild degenerative changes at the adjacent levels.On (b)(6) 2010: the patient presented with a complaint of low back pain and left leg pain.The patient underwent mri of spine which demonstrated posterior lumbar fusion at l4-l5 with inner body graft and posterolateral gutter bony fusion mass.On (b)(6) 2010: the patient presented for follow up on low back pain.On (b)(6) 2010: the patient presented to office with complaints of severe left leg pain.The patient was preoperatively diagnosed with lumbar spinal stenosis.Left l5 radiculopathy.Dural defect and underwent the following procedures: left l4-l5 hardware removal.Revision laminectomy at left l4-l5 with decompression of the left l5 nerve.Dural defect repair with muscle patch application.The patient had trialed on anti-inflammatories as well as medrol dosepac and imaging studies did demonstrate the hardware to be in good position.He failed to respond to these non operative measures.The patient wished to undergo surgical revision decompression of left l5 nerve with hardware removal on the left.The patient was admitted to hospital and underwent a revision lumbar laminectomy, left l4-l5 with decompression of left l5 nerve, as well as hardware removal.He tolerated the procedure well.On (b)(6) 2010: the patient presented with a complaint of head ache.Assessment: the patient appeared to have developed a recurrent dural defect with cerebrospinal fluid leak, status post revision lumbar surgery.On (b)(6) 2010: the patient presented to determine the efficacy of his pain medication on his left back pain.On (b)(6) 2010: the patient underwent microbiological test.On (b)(6) 2010: the patient presented for follow up on significant axial back pain with radiation into both lower extremities.On (b)(6) 2011, (b)(6) 2012: the patient presented for follow up on back pain and lower extremities radiating down his right leg.On (b)(6) 2012 , (b)(6) 2013: the patient presented with a chief complaint of low back pain with radiation into the legs bilaterally.Assessment: lumbar post laminectomy syndrome.Lumbar herniated disc.Chronic pain managed with medications.

• 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: 3895323
• MDR Text Key: 4543426
• Report Number: 1030489-2014-02914
• 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

• Date FDA Received: 06/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: No
• 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