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

Catalog Number 7510600

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

Patient Problems Neuropathy (1983); Loss of Range of Motion (2032); Tingling (2171); Injury (2348); Numbness (2415); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Weight Changes (2607)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Neither device nor applicable imaging studies returned to manufacturer for evaluation.

Event Description

It was reported that on the patient underwent posterior lumbar interbody fusion and posterior lumbar fusion surgery on the lumbar region of her spine from vertebrae l4 to l5.She was implanted with rhbmp-2/acs.Post surgery, she had progressively worsening pain in her low back, with associated pain and radiculopathy in her lower extremities.Currently, the patient continues to experience severe and chronic lower back and leg pain with radiculopathy into her lower extremities.She experiences difficulty standing and walking, and struggles with daily exercise and weight maintenance due to her pain and decreased mobility.She is unable to work and has suffered from depression.She is unable to enjoy her daily activities that she enjoyed pre-operatively, and has suffered serious and permanent injuries.

Event Description

It was reported that on: (b)(6) 2009: patient presented and reported onset of lumbar pain in (b)(6) 2008 which became more prominent in (b)(6) 2009 with radiating pain in both legs, right greater than left.Pain increases with bending and twisting.Myelogram with follow up ct scan demonstrated a large disk herniation at l4-5, more prominent to the right side with foraminal encroachment.Patient presented with preoperative diagnosis of herniated disk l4-5 right with segmental instability and underwent following procedures: laminectomy and discectomy l4-5, posterior lumbar inter body fusion of bone morphogenic protein and branigen cage l4-5.Posterior spinal fusion with bone morphogenic protein and mosaic l4-5 spinal instrumentation with monarch instrumentation l4-5.L4-5 hemaliminectomy, facetectomy with disk removal right per operative report ".Small pieces of bone morphogenic protein soaked matrix into the disk space was place and then placed a 9 x 11x 21 mm branigan cage with bmp, gently tapped it into place, rotated it, found it to be firmly seated and appropriately countersunk.Tisseel was placed over this to prevent migration of bmp material.The posterior lateral elements were decorticated with a high speed drill.Bone morphogenic protein and protein mosaic were packed in the posterolateral elements.Screws were placed in l4 and l5 pedicles.Single slot plate was chosen and tightened down with appropriate washers and torque device fit seemed good.The wound was irrigated and closed in layers." on (b)(6) 2009: patient was discharged from hospital.On (b)(6) 2009: patient presented with lumbar myelography exam due to numbness and tingling and pain in both lower extremities.Conclusion: circumferential thecal sac narrowing at l3-4 is mild.Post-fusion changes at l4-5.On same day patient also underwent a ct exam of the lumbar spine with intrathecal contrast.Conclusion: post-fusion changes at l4-5.Mild degenerative changes at l3-4 and l5-s1.Patient also underwent a radiology (cr) exam due to low back pain ,very low bilateral lower extremity pain and numbness.Conclusion: post-fusion changes at l4-5.On (b)(6) 2009: patient presented with a follow-up visit due to difficulty to sleep and constipation.This was the 2nd post-op visit after having l4-5 posterior lumbar fusion.Patient also underwent a lumbar spine radiology.Impressions: laminotomy and fusion procedure with posterior instrumentation and interbody material l4-5.On (b)(6) 2009: patient presented with an office visit.On (b)(6) 2009: patient presented with a follow-up visit due to paraspinous pain on right side and quite a bit of tenderness noted.On (b)(6) 2010: patient presented with follow-up visit due to persistent lumbar pain on the right side with bilateral leg pain.On (b)(6) 2010: patient presented with follow-up visit due to pain radiating into the left posterolateral thigh and inguinal area.Her activities are severely limited due to proximal muscle pain requiring frequent change of position considerably limiting even routine activities.Patient also underwent radiology exam of lumbar spine.Summary: post-op changes at l4-5 in the lumbar spine appeared stable.On (b)(6) 2010: patient presented with follow-up visit due to pain in right sacroiliac area.Patient also underwent a radiology exam of the lumbar spine (3 views).Impressions: no change from (b)(6) 2010.Patient also presented with si injections.On (b)(6) 2010: patient presented with a follow-up visit due to lower lumbar pain and intermittent leg pain.Patient also presented with lumbar myelogram exam.On (b)(6) 2015: patient underwent ct lumbar spine without contrast due to low back pain.Impression: image quality degradation secondary to photon depletion and steak artifact produced by the patient's body habitus.Extensive postoperative changes at l4-5 mild canal narrowing at l3-4 secondary to posterior disc bulge with a central disc protrusion, ligamentous thickening and facet joint hypertyrophy.Small, partially calcified left extraforaminal disc protrusion and associated endplate spurring at l5-s1 minimal left foraminal/extraforaminal disc bulging at l2-3.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on (b)(6) 2009, the patient was preoperatively diagnosed with herniated nucleus pulposus l4-5 right with intractable sciatica and significant spondylosis, disk space collapse and underwent the following procedure: l4-5 hemilaminectomy, facetectomy with disk removal right.Placement of brantigan cage with bone morphogenic protein and plig l4-5 right.Pedicle screw fixation and fusion l4-5.As per the op notes: ¿we then sounded and tapped the pedicles in preparation for later screw placement, removed a portion of the spinous process, lamina and medial facet on the right at l4-5, opened up the ligamentum flavum widely, identified the nerve root exiting at this level.We removed this and then entered the disk space with various size reamers up to 10 mm, placed small pieces of bone morphogenic protein soaked matrix into the disk space and then placed a 9 by 11 by 21 mm brantigan cage filled with bone morphogenic protein, gently tapped it into place, rotated it, found it to be firmly seated and appropriately counter sunk.Tisseel was placed over this to prevent migration of bone morphogenic protein material.¿ the patient tolerated the procedure well without 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5079806
• MDR Text Key: 25878729
• Report Number: 1030489-2015-02379
• 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: Initial,Followup,Followup
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2011
• Device Catalogue Number: 7510600
• Device Lot Number: M110808AAI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/22/2009
• 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: 113