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 Pain (1994); Numbness (2415); Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

It was reported that the patient underwent a procedure for transforaminal lumbar interbody fusion at l5-s1 using a peek cage and a posterolateral fusion at the same level.The cage was packed with rhbmp-2/acs.Bmp2 was also placed in the anterior disc space prior to insertion of the cage, and along the transverse processes.Following the surgery, the patient developed additional, new and/or worse pain, "symptoms and disability." specifically, the patient reportedly developed progressive, disabling pain and numbness in her legs.

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.

Manufacturer Narrative

Following are the image review findings: (b)(6) 2010 chest x-rays pa and lateral views show normal chest cavity, normal lung fields, cardiac shadow, bony anatomy and breast shadows.Lateral view shows normal thoracic kyphosis.No fractures or advanced degenerative changes.(b)(6) 2010 lumbar x-rays ap view of the lumbar spine pre-surgery.Lateral view shows awl positioning for the placement of the 4th screw into l5 and the next film shows all 4 pedicle screws presumably in l5 and s1 although this cannot be verified from this view.Last film shows screws and rods in place across l5/s1.(b)(6) 2011 lumbar ct axial levels above l5 appear normal.Screws are present at l5 and s1.Spacer is well positioned within the l5 disc.Facetectomy has been performed on the right.Some heterotopic bone exists in this area without nerve compression.Fusion appears solid.Thoracic ct axial views from the lung apices to the mid lumbar area are shown with pulmonary reconstructions.No tumor is noted.Mild degenerative changes are seen in the rib and vertebral body articulations along transverse processes and lateral vertebral bodies.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2003: the patient underwent for loop electrosurgical excision procedure (leep) due to diagnosis of mild to moderate squamous dysplasia."endocervical and ectocervical margins" were indeterminate due to fragmentation.On (b)(6) 2010 the patient underwent complete x-ray of ankle.On (b)(6) 2010 the patient underwent x-ray of chest pa and lateral.On (b)(6) 2010: the patient underwent x-ray of chest pa and lateral.On (b)(6) 2011: the patient presented for an office visit status post lumbar decompression and fusion with improvement in her intermittent low back pain.Patient was told for a follow-up after 3 months with a ct scan of lumbar spine.Musculoskeletal ros: the patient does have pain on flexion, extension, axial rotation of lumbar spine.On (b)(6) 2011 the patient underwent x-ray of chest pa and lateral.On (b)(6) 2003 the patient underwent radiographical test, pa and lateral chest due to history of chest pain and rapid heartbeat.Impression: no evidence of acute cardiopulmonary disease.On (b)(6) 2003 the patient presented with the chief complaint of tachycardia.The patient underwent ecg.Impression: paroxysmal supraventricular tachycardia.On (b)(6) 2003 the patient presented for a follow up.Assessment: benign hypertension, history of supraventricular tachycardia.On (b)(6) 2003 the patient presented for evaluation.Diagnosis: paroxysmal supraventricular tachycardia, improved with av node drugs.Hypertension, suboptimal control.On (b)(6) 2007 the patient presented with the complaint of painful urination, flank pain and pain in the back.On (b)(6) 2007 the patient presented for a follow up and complained of left arm and hand numbness.Assessment: depression no suicidal ideation.Arm and left hand numbness.On (b)(6) 2007 the patient presented for the evaluation of intermittent left arm tingling, numbness and weakness.The patient underwent nerve conduction/ electromyography.Interpretation: left ulnar nerve entrapment across the elbow, predominantly axonal type.Normal left leg examination.On (b)(6) 2010 the patient underwent complete x-ray of ankle.Impression: incidental note calcaneal enthesophytes.On (b)(6) 2010 the patient underwent x-ray of chest pa and lateral.Impression: right lower lobe bronchitis.On (b)(6) 2010 the patient was diagnosed with osteoarthrosis and benign hypertension.On (b)(6) 2010 the patient presented with the complains of sharp pain and blister on left calf and numbness to left arm.On (b)(6) 2010 the patient presented for acute care visit and complained of sore throat, blisters on throat and cough.On (b)(6) 2010 the patient presented for surgical clearance.On (b)(6) 2010 the patient presented for a follow up visit.On (b)(6) 2011 the patient presented for a follow up for chronic pain and medication refills.On (b)(6) 2011 the patient presented with complains of cough and associated symptoms included fatigue and sore throat.On (b)(6) 2011 the patient underwent x-ray of chest pa and lateral.Impression.Congenital block vertebra in the lower thoracic spine.Minimal lower lobe atelectasis or bronchitis.On (b)(6) 2011 the patient presented for discussion of specialty referral.On (b)(6) 2013 the patient presented with the complaint of sore throat and cough.The patient underwent a diagnosis test and was diagnosed with lumbago, bronchitis, chronic airway obstruction, benign hypertension, anxiety, tobacco use disorder, flu with respiratory manifestation not elsewhere classified.On (b)(6) 2013 the patient presented for a follow up visit for back pain.On (b)(6) 2013, on (b)(6) 2012 the patient presented with complain of difficulty in breathing and shortness of air.On (b)(6) 2013 the patient underwent a radiological test of the chest due to cough and shortness of breath.Impression: no acute disease.On (b)(6) 2013 the patient presented for acute care visit.She complained of sore throat, cough and dizziness.The patient underwent radiological test of the chest.Two views were taken.Impression: mild lower lobe bronchitis.On (b)(6) 2013 the patient presented for a follow up visit.On (b)(6) 2014 the patient presented for a health maintenance visit.On (b)(6) 2014 the patient presented with the complaint of left shoulder and swelling in arm due to a fall off lawn chair.She also complained of weight gain and generalized swelling.The patient underwent a radiological test of the left shoulder.Impression: normal left shoulder.On (b)(6) 2015, and (b)(6) 2014 the patient presented for an office visit with complaint of cough and for medication refills.She described cough as productive and associated symptoms included chest tightness, fatigue, nasal congestion, weakness and sore throat, hoarseness and bad taste in mouth.

Event Description

Additional information from the patient's medical records indicate that on: (b)(6) 2010: the patient was admitted with pre-operative diagnoses of lumbar degenerative disc disease with radiculopathy at, l5-s1 due to indication of low back pain r>l, and was subsequently scheduled for l5-s1 transforaminal lumbar interbody fusion (tlif) with cell saver surgery.The patient underwent following procedures: 1.Posterior lateral arthrodesis using compression resistant matrix, bmp and local bone graft for posterior lateral fusion at l5-s1.2.Lumbar decompression at l5-s1 to decompress the l5 nerve root.3.Lumbar decompression at l5-s1 to decompress the s1 nerve root.4.Posterior lateral instrumentation nonsegmental l5-s1 using pedicle screws.5.Posterior interbody arthrodesis using peek cage, bmp and local bone graft.6.Insertion of biomechanical device for the lumbar fusion at l5-s1.Per the op notes, end plates scrapers were used to prepare the disc space for interbody fusion.Once this was completed, a construct of bmp locally harvested bone was then placed anterior into the disk space and an 8mm peek cage had been previously filled with bmp and morselized bone graft was then placed behind the cage.The cage was tamped anteriorly and rotated.A lateral radiograph was taken and showed cage in good position.A posterior lateral fusion was then completed using the arthrodesis constructed of bmp, compression resistant matrix and locally harvested bone.This was placed upon the transverse process of l5 and the sacral ala.Intraoperatively, the patient also underwent for x-ray of lumbar spine 1 view.Surgical screws were seen in projection with l5 and s1.A surgical instrument was seen in projection with the top of l5.A new spacer was seen at the level of the l5-s1 disk space.Rods have been added to the surgical screws bridging l5 and s1.Alignment appeared anatomic.Surgical screws were seen in projection with the l5 and s1 vertebra.The patient's x-ray of lumbosacral spine 2 or 3 views was taken from the operating room.Nem monitoring was performed throughout the case.No complications were reported.(b)(6) 2010: the patient presented with chief complaint of post-surgical infection.Patient followed up for cough and pain management.Pink drainage, reddened area at surgical site noted.(b)(6) 2010: the patient presented with chief complaint of soreness at right hip and back and tailbone pain status post tlif l5-s1.(b)(6) 2011: the patient presented with complaint of back ache and tailbone pain status post tlif l5-s1.Incision looked dry with no drainage noted.(b)(6) 2011: the patient presented with complaint of mild pain, not being able to lie down and popping sound in back when moving.The patient also underwent for ct scan of lumbar spine without contrast due to diagnosis of low back pain.(b)(6) 2011: the patient presented for an office visit after getting her ct finished.(b)(6) 2011: the patient presented with lumbago and underwent for ct scan of lumbar spine without contrast due to low back pain.Impression: the patient is status post posterior fusion with interpedicular screws and posterior rods at the l5-s1 levels.Laminectomy defect with soft tissue post-surgical changes are noted at the l5 level.Surgical hardware appears to be in good position and alignment.The lumbar elements are in anatomic alignment with no evidence of compression abnormalities or obvious significant soft disk protrusions.(b)(6) 2011: the patient presented with complaint of low back pain status post tlif l5-s1.Patient's ct scan showed no dislodgement or malposition of her hardware interbody fusion mass.(b)(6) 2011: the patient presented for an office visit status post lumbar decompression and fusion with improvement in her intermittent low back pain.Patient was told for a follow-up after 3 months with a ct scan of lumbar spine.(b)(6) 2011: the patient presented with complaint of neck pain.On same day, the patient underwent for ct scan of lumbar spine without contrast due to back pain.Impression: 1.L4-l5 facet joint degeneration with trace anterolisthesis of l4 on l5.2.Stable l5-s1 posterior fusion in anatomic alignment.3.Otherwise within normal limits.The patient also underwent ct scan of thorax with contrast because of abnormal chest x-ray.Impression: coarse linear band in the right middle lobe that may be a post inflammatory scar.Follow-up to resolution suggested.If persistent or progressive, right middle lobe bronchoscopic assessment suggested.(b)(6) 2012: the patient was admitted to er with chief complaints of cervicalgia, depression and was discharged on same day, patient also underwent urinalysis.Impression: depression (not otherwise specified), drug abuse, mixed (unspecified).(b)(6) 2013: the patient was admitted with diagnosis of benign hypertension; low sodium and potassium.

• 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: 4330559
• MDR Text Key: 5134494
• Report Number: 1030489-2014-04731
• 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,Followup,Followup,Followup
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2013
• Device Catalogue Number: 7510800
• Device Lot Number: M110909AAI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2010
• 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 Age: 35 YR
• Patient Weight: 86