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 Scar Tissue (2060); Neck Pain (2433); Osteopenia/ Osteoporosis (2651)

Event Type  Injury  

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.

Event Description

It was reported that on an unspecified date in (b)(6) 2007, patient underwent lumbar fusion.On an unspecified date in (b)(6) 2009, patient underwent surgery at l5-s1 with anterior and posterior instrumentation.On (b)(6) 2009: the patient presented for a follow up.Patient underwent x-ray of the lumbar region which showed anterior posterior spinal fusion of l5-s1.All instrumentation was appropriate.No signs of change.Within the interbody fusion device, there were signs of what appears to be bone formation.On (b)(6) 2009: the patient presented for a follow up.Patient presented with back pain.Patient underwent x-ray of the lumbar region which showed lumbar (ap/lateral): alif/psf l5-s1 in good overall alignment.God placement of instrumentation.No abnormalities.On (b)(6) 2009: patient presented with post diagnosis: pseudoarthrosis l5-s1 with prior posterior spinal fusion.Procedures: posterior arthrodesis of l5-51.Harvesting of right iliac crest bone graft through inner fascial exposure.Use of intraoperative fluoroscopy for instrumentation placement and localization.Posterior spinal fusion l5-s1 and also anterior removal of interbody device with anterior interbody fusion placement.Patient underwent ap, lateral, lumbar x-ray which shows an l5-s1 posterior spinal fusion with interbody fusion device markers.Overall instrumentation was appropriate, no signs of abnormality.Patient underwent ct myelograrnxxx recently shows a posterior: spinal fusion of l5-s1, all instrumentation was appropriately placed however; the l5-s1 interbody fusion device does not show any significant signs of bone formation across the disk space through the device.Op notes: two full-thickness skin incisions were made with scalpel followed by incision of the fascial layer.The quadrant system was used for this portion of the case.Then, the retractor' blades were placed deep into the wound to expose the pedicle screws bilaterally.Soft tissue was rem oved as necessary with electrocautery and pituitary rongeur.Set screws were loosened on both sides.Then elected to take a portion of the right iliac crest bone graft.The anterior procedure was then done next.The low lumbar area was then replaced and draped after the ioban was removed sterilely.Also, the ray-tecs were removed sterilely.With the prior incisions already made in the posterior aspect the procedure was completed.The quadrant system was then replaced into both wounds and the retractor blades to retract the soft tissues were done.Each set screw was then removed as well as the rod.The posterior arthrodesis portion of the procedure was then done next.Facet joint was noted to be intact on the preoperative ct scan.Then, the remaining portions of the iliac crest autograft were wrapped in the collagen-soaked sponges.This was then placed into the graft site at the facet joints bilaterally.This was done without any significant difficulties.The rod was then replaced and set screws were then tightened down.Slight compression was applied across both setscrews, the pedicle screws at l5-s1.The final ap and lateral film were then taken and showed good placement of instrumentation.No complications were reported.Procedure: anterior diskectomy of l5-s1 with anterior removal of instrumentation, posterior interbody fusion device.Anterior interbody biomechanical device placement, l5-s1.Anterior arthrodesis, l5-s1.Op notes: with the exposure provided, the l5-s1 disk space was visualized and incised with a 15-blade scalpel.However, with the disk material was removed and then exposed the underlying device, peek cage.Eventually, surgeon was able to work the implant out far enough to then be able to grab onto it with a kocher to then remove the implants nearly intact.A perimeter 12-mm peek cage was then opened up on the back table.It was packed with autograft and the iliac crest graft that was harvested on the initial posterior aspect of the procedure.This was placed within collagen rhbmp-2/acs-soaked sponges.Once it was at the correct depth, intraoperative fluoroscopy was taken to confirm this as well.On (b)(6) 2009: patient underwent mri of the lumbar region which shows minimal posterior disc bulges at l3-l4 and l4-5 with a tiny annular fissure at l4-5.Impression: minimal posterior disc bulge at l3-l4.Mild posterior disc bulge at l4-l5 with tiny annular fissure.Residuals of l5-s1 discectomy and spinal fusion, with extensive left eccentric paracentral posterolateral enhancing fibro granulation tissue filling the left lateral recess and surrounding the s1 nerve root.No clear evidence of recurrent disc protrusion the left s1 root sleeve was somewhat tethered and distorted.On (b)(6) 2009: the patient presented for a follow up.Patient underwent mri which shows a mild l4-5 posterior disc bulge only.L5-s1 does show the prior laminectomy site with the disc bulge, but no signs of recurrent disc herniation.On (b)(6) 2009: patient underwent x-ray of the abdomen region.Impression: no acute cardiopulmonary disease.No radiographic evidence for acute abdominal disease.On (b)(6) 2009: patient presented with back pain.Patient underwent x-ray of the lumbar region showed intact fusion with screw fixation at l5-s1.There appeared to be generalized osteopenia.Impression: postoperative changes lumbosacral junction.No definite additional abnormality.If the patient had symptoms attributable to the si joint, dedicated si joint series would be recommended.On (b)(6) 2009: the patient presented for a follow up.Impression: failed back syndrome, status post l5-s1 fusions.Possible chronic lumbosacral radiculopathy.On (b)(6) 2009: the patient presented for a follow up.Patient underwent ct scan which showed the surgery at l5-s1 with a subsequent instrumentation placement.On (b)(6) 2010: patient presented with neck, low back pain, left arm and bilateral hip pain.Patient underwent x-ray of the cervical spine.Impression: cervical degenerative disc disease with left cervical radiculopathy, c4-5, c5-6.2) s/p lumbar laminotomy with anterior posterior interbody fusion, with persistent back and bilateral buttock and thigh pain.On (b)(6) 2010: patient had cervical spine pain and bilateral shoulder pain and left arm pain.Conclusion: there was no evidence of neural impingement.C3-c4, there was mild right facet joint arthropathy.Signal changes were noted within the pons on the left, likely representing peculiar virchow-robin spaces.Patient underwent mri of the lumbar spine.Impression: l5-51, the patient was status post fusion surgery.There was contrast enhancement along the left lateral and ventral epidural space, compatible with epidural and perineural fibrosis.No recurrent or residual disc protrusion, extrusion or sequestration was identified.However, according to patient's information sheet, the patient's symptoms were bilateral.L4-5 (superior junctional level), a central dorsal high intensity zone was seen that may represent an annular fissure.On (b)(6) 2010: patient underwent x-ray of the lumbar region.Impression: lumbar (ap/lateral): anterior posterior spinal fusion l5-s1.Interbody fusion device was well placed with no signs of abnormality.There does appear to be bone forming with inside the device extending from the end plate of l5 to s1.Pedicle screws were also well aligned with no changes.On (b)(6) 2010: the patient presented for a follow up.Patient presented with neck and back pain.Cervicothoracic, lumbar strain 2.Status post lumbar laminotomy, l5-s1 left, with anterior lumbar interbody fusion, l5-s1, with persistent back and bilateral buttock and thigh pain.On (b)(6) 2010: patient presented with chronic lumbar spine pain and scar tissue developed around s1 nerve root.On (b)(6) 2010: patient underwent x-ray of the spine cervical.Patient underwent mri of the cervical spine.Impression: mild degenerative spurring from c4 to c7 with some mild disc space narrowing.There was some mild degenerative change seen involving the facet joints and uncovertebral joints.No definite acute bony changes was noted.On (b)(6) 2011: patient underwent ct scan of the spine lumbar w/o contrast.Patient with history of trauma and two spine fusions at l5-s1 (psf <(>&<)> alif).On (b)(6) 2011: patient underwent ct scan of the spine lumbar w/ contrast.Status post l5-s1 spinal fusion.Moderate ventral extradural defect at the l4-l5 level extending slightly superiorly and shadow ventral extradural defect at the l3-l4 level.Evidence for left hemilaminectomy at the l5-s1.Mild ventral extradural defects on the thecal sac at the t5-t6, t6-t7, and t7-t8 levels.On (b)(6) 2012: patient presented with low back pain, degenerative disc disease, painful hardware.Patient underwent x-ray of the spine.Impression: status post l5-s1 spinal fusion.Moderate ventral extradural detect at the l4-l5 level extending slightly superiorly and shallow ventral extradural defect at the l3-l4 level evidence for left hemilaminectomy at the l5-s1 level.Mild ventral extradural defects on the thecal sac at the t5-t6, t6-t7, and t7 -tb levels.Patient underwent ct scan of the thoracic and lumbar spine.Status post l5-s1 posterior spinal fusion without evidence for hardware loosening.Bony fusion of l5-s1.Degenerative changes of the lower lumbar spine as described above, most severe at the l4-l5 level.Mildly irregular sacrum and coccyx without definite evidence for sacrococcygeal fracture.On (b)(6) 2012: patient reports arm problems, back problems, chronic pain, hip problems and leg problems.On (b)(6) 2013: patient presented for follow-up.Patient presented with back pain in back pain in the lower lumbar region radiating through the sacrum, sciatica, lumbar back pain, lumbar strain.Patient had a previous ct myelogram done that showed no signs of abnormality of l5-s1 and she had a documented fusion at that level.Patient had a previous anterior posterior spinal fusion l5-s1 for pseudoarthrosis.

• 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: 5090461
• MDR Text Key: 26296778
• Report Number: 1030489-2015-02432
• 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: 06/01/2011
• Device Catalogue Number: 7510800
• Device Lot Number: M110711AAR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/19/2008
• 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: 56