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

Catalog Number 7510100

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

Patient Problems Adhesion(s) (1695); Bone Fracture(s) (1870); Neuropathy (1983); Pain (1994); Ambulation Difficulties (2544)

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 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.

Event Description

It was reported that on (b)(6) 2010, the patient underwent a spinal fusion surgery (posterior lumbar interbody fusion and posterolateral lumbar fusion surgery) on the lumbar region of her spine from vertebrae l4 to l5.Reportedly, during the surgery, select parts of rhbmp-2 (i.E.Only the rhbmp-2 and collagen sponge) were used in the patient from a posterolateral and posterior approach.It was also reported that the rhbmp-2 collagen sponge was placed outside a cage (i.E., in the disc space and posterior elements).As reported, the patient's post-operative period had been marked by severe and chronic lower back pain, with pain and radiculopathy in her lower extremities; difficulty walking, sitting and standing; and occasional use of a walker to assist with ambulation.

Event Description

The patient was presented with following pre-op diagnosis: 1.Bilateral lumbar radiculopathy.2.Degenerative spondylolisthesis, l4-l5.3.Spinal stenosis, l3-l5.4.Bilateral foraminal stenosis, l3-l5.5.Degenerative disk disease, l3-s 1.6.Status post laminectomy, l4-l5 with right diskectomy.7.Status post postoperative infection, l4-l5.8.Obesity.She underwent following procedures: 1.Redo bilateral laminectomies, l4-l5 with foraminotomies.2.Partial laminectomy, l3-l4 with bilateral foraminotomies.3.Neurolysis, right l4 nerve root.4.Posterior lumbar interbody fusion, l4-l5.5.Insertion of tricortical allograft prostheses, right l4-l5.6.Posterolateral fusion, l4-l5.7.Insertion of extra, extra small bone graft.8.Insertion of allograft cancellous bone chips.9.Insertion of autograft bone from the decompression.10.Insertion of sequoia spinal instrumentation at l4-l5.11.Partial reduction of spondylolisthesis at l4-l5.As per the op-notes, ¿i did foraminotomies of the adjacent nerve roots and i decompressed the lateral recesses proximal to this.At left l4-l5, i did find a moderate sized facet cyst.It did appear to have synovial fluid in it.On the mri from fall of 2009, i did not see any fluid in a left l4-l5 facet cyst.In addition, i did find evidence of a facet cyst at left l5.A wide foraminotomy was performed and i completely decompressed the left l5 nerve root.I decompressed the lateral recess proximal to this.I did feel that the patient's increased left leg pain was due to, at least in part, a left l4-l5 facet cyst.The patient also did have severe bony lateral recess stenosis at left l3-l4, and a large osteophyte did extend into the foramen adjacent to the left l4 nerve root.This was also decompressed.As mentioned, it was hard bony osteophyte.A wide foraminotomy of the left l4 nerve root was performed.I placed bmp and allograft cancellous bone chips.This was impacted.I then placed 3 tricortical allograft prostheses.These were impacted anterolaterally.Posterior to this, i placed autograft bone from the decompression that was meticulously cleaned.I also placed a small amount of allograft.I did not pack the interspace full and i allowed some room for subsidence.After final impaction, distraction was released and the prostheses were nicely compressed and stable.I then obtained a 35 mm rod.It was locked into position at right l4-l5.The construct was placed under a neutral position.I did do a partial reduction of the spondylolisthesis.I then placed bone screws into the pedicles of left l4 and left l5.They were placed in a similar fashion by drilling, probing and tapping.I used 5.5 mm screws.Good fixation was obtained.I decorticated the transverse processes of l4 and l5.I resected the facet joint and decorticated this and decorticated the lamina of l4 and l5.I then did a posterolateral fusion.I placed allo graft chips, bone graft, and autograft bone from the decompression; that was meticulously cleaned.This was all placed posterolaterally and impacted.I also placed bone into the decorticated facet joint at left l4-l5.I placed a 35 mm rod.It was locked into position and placed under slight compression.The remaining bone graft was then placed posterolaterally and into the facet joint.After final impaction, i did place a transverse connector between the 2 rods.This was locked into position.Subsequent x-ray showed good position of the hardware and of the interbody prostheses.The wound was irrigated throughout the procedure with antibiotic irrigation.A medium hemovac drain was placed below the fascia.Fascia was then closed with #1 pds using both interrupted and running sutures.A watertight closure was obtained.Subcutaneous was closed with 0 pds to the deep layer, 2-0 vicryl to the superficial layer, and the skin was closed with 4-0 monocryl.Steri-strips were applied and dressing.The patient was sent to the recovery room in stable condition.Blood loss for this procedure was 150 cc.I was assisted throughout this procedure by sarla persaud, pa-c.This procedure was made more difficult due to the extensive scar tissue that was present from prior surgery.Post ¿op diagnosis were: 1.Severe adhesions, l4-l5.2.Facet fracture, right l4-l5.3.Facet cyst left l4-l5.No intra-op complications were observed.

Manufacturer Narrative

Additional info: a1, b5, d4, h4, h6 h6: due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• 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
• MDR Report Key: 5392264
• MDR Text Key: 36901156
• Report Number: 1030489-2016-00290
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 11/01/2018

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: 01/14/2010
• Device Catalogue Number: 7510100
• Device Lot Number: M110813AAD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/04/2016
• Initial Date FDA Received: 01/27/2016
• Supplement Dates Manufacturer Received: 10/02/2018
• Supplement Dates FDA Received: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other