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 Muscle Weakness (1967); Stenosis (2263); Joint Swelling (2356)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(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.

Event Description

It was reported that on (b)(6) 2004, patient reported low back pain, weakness of both legs, severe right calf pain as well as a feeling of weakness in the right leg.Lumbar mri showed very severe spinal stenosis at l3-4.He had almost no room available for the cauda equine that was obviously dramatically compressed.At l2-3 he had mild stenosis.His prior l4-5 laminectomy was visualized and appears to be adequately decompressed.X-rays of lumbar flexion-extension showed evidence of laminectomy that seems to be centered on l4-5.At l3-4 patient had mobile spondylolisthesis.On (b)(6) 2004, patient presented for follow-up three weeks post lumbar fusion.Patient reported paresthesias.X-rays confirmed our l2-3 to l5 decompression that appeared adequate.Pedicle screw rod fixation spanning l3-4 was visualized.That appeared to be well positioned.A 2-3mm spondylolisthesis at l3-4 was seen.On (b)(6) 2005, patient presented for follow-up three months post lumbar decompression and fusion.Patient reported tightness and dysesthesias in left lower extremity; weakness had improved post-op.X-rays showed l3-5 decompression.Pedicle screw rod fixation spanning l3-l4 was visualized and remains well positioned.The posterolateral fusion appears to be developing more so on the left side.On(b)(6) 2005, patient reported hurting his finger.X-ray views of the ring finger taken today showed good bone quality and alignment.There was no evidence of fracture or dislocation and no evidence of degenerative process.There was a small retained fragment in the pulp of the small finger, but this was old.On (b)(6) 2005, patient presented for follow-up post regarding his left ring finger allen type i partial amputation of the fingertip sustained on (b)(6), 2005.X-ray views of the ring finger taken today showed good bone quality and alignment.There was no evidence of fracture or dislocation and no evidence of osteomyelitis or deeper infection.On (b)(6) 2005, patient presented for follow-up five months post lumbar decompression and fusion.Patient reported tightness in the left thigh and calf.X-rays showed l3-4 pedicle screw rod instrumentation.These appear to be appropriately placed.There appears to be a developing posterolateral fusion at this level.On (b)(6) 2005, patient presented for follow-up one year post lumbar decompression and fusion.Patient reported severe back pain radiating down the right leg in a sciatic distribution and weakness in right leg.X-rays showed l3-4 instrumented fusion construct.There were some lucencies around the screws.There was no evidence to suggest fusion of the posterolateral graft.On (b)(6) 2005, patient reported low back pain, paresthesias in both legs.Patient underwent a ct scan which showed the 3-4 decompression and instrumented fusion.There appears to be almost no posterolateral bridging bone and i believe he does indeed have a pseudarthrosis.As far as the decompression goes, he doesn't have any clear-cut residual stenosis.On(b)(6) 2006, patient reported severe back pain that was mostly aggravated by changing of positions, getting up from a seated position, right leg pain while standing or walking.X-rays showed l3-4 decompression with pedicle screw instrumentation across this level.There appears to be no posterolateral bony fusion.There was a halo particularly around the l4 screws and subtle lateral shift of l2-3.On (b)(6) 2006, mri and ct were reviewed which showed: pedicle instrumentation at l4-5 to be well positioned.There was no evidence of healing of the fusion posterolaterally.The laminectomy appeared to be adequate at l4-5.There may be some mild, particularly foraminal, stenosis above at l3-4 and also perhaps in the l4-5 and 5-1 foramina.On (b)(6) 2006, patient presented to discuss for l3-4 interbody fusion to treat this pseudarthrosis.On (b)(6) 2006, patient underwent following procedure: 1.L3-4 anterior diskectomy.2.L3-4 interbody fusion (xlif) with peek cage and rhbmp-2/acs.3.Posterior l2-3-4, 4-5 laminectomy and lateral recess decompression; for following pre-op diagnosis: 1.L2 3-4 spinal stenosis.2.L3-4 pseudoarthrosis.Per-op notes: the diskectomy was performed with a series of rotating box cutters, curettes, ring curettes.After adequate diskectomy was performed then again we confirmed position of our instruments with ap fluoroscopy.It was decided that a 10 x 18 x 55 peek cage would be used.A 10 x 18 x 55 peek cage with rhbmp-2/acs in the center was then prepared.This was then gently impacted at the l3-4 disk space taking serial photos with fluoroscopy to ensure appropriate position.We confirmed the position of our peek cage with the ap and lateral fluoroscopy and found it to be in excellent position.No complications were reported during the procedure.On (b)(6) 2006, patient presented for follow-up three weeks post xlif and redo posterior decompression fusion.X-rays showed l3-4 xlif that remains well positioned.Screws across this level were appropriately positioned.There appears to be a good laminectomy.On (b)(6) 2007, patient presented for follow-up post xlif.Patient reported anterior thigh weakness and tightness around the knee.Patient reported back pain and stenotic symptoms had improved.X-rays confirmed our interbody construct with the posterior instrumentation; all looked appropriate.On (b)(6) 2007, patient presented for follow-up six months post xlif.Patient reported axial low back pain and knee pain.X-rays confirmed our lumbar decompression.The pedicle screws at l3-4 were well positioned.The interbody xlif device also remains well positioned.There appears to be good bridging bone particularly lateral at l3-4.On (b)(6) 2007, patient reported left knee pain which started four years ago.Patient reported tightness and decreased sensation of left knee, tearing or ripping pain, starting from the middle of his knee and working its way up through his adductor and his knee feels unstable.X-rays showed normal knee with no bony abnormalities.However, there was a subtle narrowing of the left medial compartment.Patient was administered cortisone injection in left knee.On (b)(6) 2008, patient reported left knee pain.Pain improved for a while after cortisone injections.On (b)(6) 2008, patient underwent mri of left knee.Impression: 1.Myxoid degeneration of both menisci with a tear of the posterior horn of the medial meniscus.2.Cruciate ligaments were intact as were the collateral ligaments.3.Small joint effusion on (b)(6) 2008, patient reported soreness and pain in knee.Also, there was some giving away of knee.Mri from (b)(6) 2008 showed slight degeneration of the meniscus with a tear in the posterior horn of the medial meniscus of the left knee.He had very mild degenerative changes in the knee.Impression was left knee pain consistent with early degenerative changes and medial meniscus tear.On(b)(6) 2008, patient underwent left knee arthroscopy, medial meniscectomy, chondral debridement of the trochlea and patella for pr e-op diagnosis of left knee medial meniscus tear, left knee osteoarthritis, patellofemoral joint.On (b)(6) 2008, patient presented for follow-up post left knee arthroscopy, medial meniscectomy, chondral debridement of the trochlea and patella.On (b)(6) 2008, patient presented for follow-up three weeks following his left knee arthroscopy and debridement.Patient reported flare up of pain and swelling in knee.

• 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: 5096309
• MDR Text Key: 26512684
• Report Number: 1030489-2015-02472
• 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: 08/24/2015

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: 04/01/2009
• Device Catalogue Number: 7510800
• Device Lot Number: M115008AAH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/28/2006
• 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: 116