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

Catalog Number 7510050

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

Patient Problems Chest Pain (1776); High Blood Pressure/ Hypertension (1908); Nausea (1970); Neuropathy (1983); Pain (1994); Pneumonia (2011); Rash (2033); Sprain (2083); Swelling (2091); Urinary Tract Infection (2120); Tingling (2171); Stenosis (2263); Injury (2348); Depression (2361); Numbness (2415); Neck Pain (2433); Ambulation Difficulties (2544); Dysuria (2684)

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

Levels: l4-s1 it was reported that on (b)(6) 2011, patient underwent spinal fusion surgery on the lumbar region at l4-s1 where selected parts of r hbmp-2/acs (i.E only rhbmp-2 and collagen sponge) were used.The rhbmp-2 collagen sponge was placed outside the cage.Post-op, patient complained of severe and unrelenting pain in low back.The patient had difficulty in sitting, standing and walking and required use of crutches or a cane to assist with ambulation.The patient also suffered from depression.These serious injuries prevent the patient from practicing and enjoying the activities of daily life that patient enjoyed pre-operatively, and had otherwise suffered serious and permanent injuries.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on: (b)(6) 2011: patient under went cardiothoracic surgery.Pre-op diagnosis: lumbar back pain, status post posterior fusion.Procedure: anterior exposure for discectomy and bony fusion at l4-l5 and l5-s1.Patient also underwent neurosurgery.Pre-op diagnosis: status post l4-s1 posterolateral fusion remotely.Left l5-s1 radiculopathy.L4-s1 degenerative disk disease.Procedure: open anterior exposure of l4s1.L4-s1 anterior lumbar inters body fusion.L4-l5, l5-s1 peek inter body spacer device.Autograft/bmp.Pre-op notes: surgeon proceeded down to the l5-s1 disk space.Surgeon obtained ap, lateral fluoroscopy to confirm those levels prior to doing any disk work.Surgeon then took an epidural vein sealer and coagulated the l5-s1 anterior annulus.We then took a bovie and also performed an annulotomy supplemented by a 15 blade.We then used a series of curettes, pituitaries, disk shavers in order to prepare the endplates for cage insertion.We obtained a lateral fluoroscopy image with the 10 trial.Once we had good placement of the trial, we then filled the 10 mm peek inter body spacer device with allograft and bmp.We then knocked in the cage after confirming that there were no free disk fragments.We then obtained a lateral fluoro image, which showed good position.I used a tamp in order to further place the cage posteriorly, then took a kocher and tugged on the cage to make sure it was snug.The cage did not move with pulling.We then repeated this process at the l4-l5 disk space with annulotomy, diskectomy, trial and ultimately placement of the peek inter body spacer device with allograft and bmp.We again obtained a lateral fluoro image as well as an ap image of both levels, which showed the cage was in good position.Once this had been completed, we obtained hemostasis and dr.(b)(6) completed an abdominal closure.All counts were correct at the end of the case and there were no complications.On (b)(6)2011: patient presented for office visit.Diagnosis: chronic pain syndrome.Assessment: s/p alif l4-s1.Neuropathic and muscular pain.On (b)(6)2011: patient presented for office visit.Diagnosis: s/p lumbar fusion.Assessment: s/p lumbar fusion.Neuropathic pain.Knee pain related to increased stress.On (b)(6) 2011: patient under went ultra sound doppler exam of left lower extremity.Indication: swollen and painful calf.On (b)(6) 2011: patient presented for office visit.Diagnosis: foot pain and rash.On (b)(6) 2011: patient presented for office visit.Diagnosis: balance problem.Patient under went 2 views lumbar spine.Impression: stable postop changes.On (b)(6) 2011: patient presented for office visit.Diagnosis: s/p lumbar fusion.Assessment: hx of lumbar fusion.Opioid dependent.On (b)(6)2012: patient presented for office visit.Diagnosis: s/p lumbar fusion.Assessment: chronic pain.Hx of neck and back surgery.On (b)(6) 2012: patient presented for office visit.Diagnosis: back pain.Assessment: hx of fusion low back.On (b)(6) 2012: patient presented for office visit.Diagnosis: s/p lumbar fusion.Back pain.Assessment: hx of neck and back fusion.De conditioned.On (b)(6) 2012: patient presented for office visit.Diagnosis: foot pain.Patient under went x-ray of left foot.Findings: no fracture or dislocation.Normal alignment.On (b)(6) 2012: patient presented for office visit.Diagnosis: s/p lumbar fusion, s/p cervical spinal fusion.Assessment: hx of lumbar fusion.Hx of neck surgery.Deconditioned.Patient under went x-ray c-spine w flex and ext, xr l-spine ap/lat upright, xr c-spine w flex and ext.Findings of xr l-spine ap/lat upright: alignment of the lumbar spine is normal.Stable surgical changes of a lumbar sacral fusion.No change in fusion cage involving the left si joint.Findings of c-spine 5 views: previous anterior plate and screw fixation c5 - 6 levels with inter body spacer.Previous posterior fusion surgery with threaded pedicle screws and posterior stabilizing rods extending f r om the c4- c6 level.Cervical spondylosis with hyper trophic change at the c4- 5 and c6- 7 level.Stable alignment with flexion and extension.No acute osseous abnormality.On (b)(6) 2012: patient presented for office visit with swollen foot.Diagnosis: pneumonia.Cough.Back pain.Foot pain.On (b)(6) 2012: patient presented for office visit with pneumonia, flu and cough.Diagnosis: cough.On (b)(6) 2012: patient presented for office visit.Diagnosis: chronic pain syndrome, s/p lumbar fusion, cervical stenosis of spinal canal.On (b)(6) 2012: patient presented for office visit.On (b)(6) 2012: patient presented for office visit with cough.Diagnosis: chest wall pain.On (b)(6) 2012: patient presented for office visit with ear ache.Diagnosis: acute otitis media, acute bronchitis and tobacco abuse.On (b)(6) 2012: patient presented for office visit with earache.Assessment: acute otitis media, acute bronchitis.On (b)(6) 2012: patient presented for office visit.Diagnosis: low back pain.Patient under went xr l-spine ap/lat/flex/ext and xr c-spine ap/lat upright.Findings of xr l-spine ap/lat/flex/ext: screw rod fusion posteriorly from l4-s1.No obvious fracture or loosening.No obvious disruption of the disc space prostheses.Fusion at the left sacroiliac joint, also stable in appearance.Findings of xr c-spine ap/lat upright: anterior side plate and screw fixation at c5- c6 with prosthetic elevation of the disc space.Posterior fusion from c4 through c6.No disruption of the metallic fusion elements.Normal alignment and position in the neutral position.Poor range of motion in flexion and extension, as might be expected.There is no evidence of motion within the fusion segment.On (b)(6) 2012: patient under went bilateral full field digital screening mammogram.Findings: the breasts are heterogeneously dense.No evidence of malignancy.On (b)(6) 2012: patient presented for office visit with chest pain.Patient under went x-ray chest ap/pa and lat 2 views.Findings: lungs are clear.Surgical clips in anterior chest.No adenopathy or effusion.Normal cardiac size and pulmonary vascularity.Postop changes in cervical spine, partially visualized.On (b)(6) 2012: patient under went ct of cervical spine.Impressions: solid c5-6 interbody fusion.C4-c6 posterior instrumented fusion.The right facets are fused.The left facets are equivocally fused.No instrumentation loosening or migration.Mild to moderate left c6-7 neural foraminal stenosis.No other neural foraminal compromise.No spinal canal stenosis.No significant interval change.On (b)(6) 2013: patient presented for office visit with pain.Diagnosis: low back pain, hypertension.On (b)(6) 2013: patient presented for office visit with dysuria.Diagnosis: dysuria, nausea, urinary tract infection, bronchitis.On (b)(6) 2013: patient presented for office visit with right dorsal radial wrist and thumb pain.Patient under went x-ray.Impression: unremarkable.The patient also has some numbness and tingling at the tip of her thumb.On (b)(6) 2013: patient presented for office visit.Diagnosis: sprain of wrist.Patient under went radiography.Impression: no fracture, dislocation or instability pattern with the wrist.At this time is a fair amount of dysesthesia secondary to wrist pain.On (b)(6) 2013: patient presented for office visit with wrist injury.Diagnosis: thumb pain.Patient under went x-ray.Impression: x-ray shows no sign of fracture or dislocation.On (b)(6) 2013: patient presented for office visit with chronic pain.Diagnosis: chronic pain syndrome, right hand pain, depression with anxiety.On (b)(6) 2013: patient presented for office visit.Diagnosis: pain in joint.Patient under went a mri.Impression: different ligaments exist within the wrist and patient has had a sprain of the wrist.On (b)(6) 2015: patient presented for office visit with back pain and neck pain.Assessment: chronic pain syndrome.Post laminectomy syndrome of lumbar region.Sarcoidosis.Depression.On (b)(6) 2015: patient presented for office visit with back pain.Assessment: chronic pain syndrome.Post laminectomy syndrome of lumbar region.Sarcoidosis.Depression.On (b)(6) 2015: patient presented for office visit with back pain.Assessment: chronic pain syndrome.Post laminectomy syndrome of lumbar region.Sarcoidosis.Depression.

Manufacturer Narrative

Additinal information: b5,b7, d4 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.

Event Description

It was reported that the patient was pre-operatively diagnosed with: status post l4-s1 posterolateral fusion remotely.Left l5-s1 radiculopathy.L4-s1 degenerative disc disease and underwent the following procedures: open anterior exposure of l4-s1.L4-s1 anterior lumbar interbody fusion.L4-l5, l5-s1 peek interbody spacer device.Autograft/ bmp.As per op-notes,¿ we then used a series of curettes, pituitaries, disc shavers in order to prepare the endplates for cage insertion.We obtained a lateral fluoroscopy image with the 10 trial.Once we had a good placement of the trial, we then filled the 10mm peek interbody spacer device with allograft and bmp.We then locked in the cage after confirming that there were no free disc fragment, then obtained a lateral fluoro image, which showed good position.I used a tamp in order to further place the cage posteriorly, then took a kocher and tugged on the cage to make sure it was snug.The cage did not move with pulling.We then repeated this process at the l4-l5 disc space with annulotomy, discectomy trial and ultimately placement of the peek interbody spacer device with allograft and rhbmp2.¿ the patient tolerated the procedure well without any intraoperative complications.

• 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: 5154362
• MDR Text Key: 28444366
• Report Number: 1030489-2015-02695
• 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: Followup,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2012
• Device Catalogue Number: 7510050
• Device Lot Number: M111102AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/06/2011
• 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