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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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| Model Number 7510200 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Pain (1994); Swelling (2091); Numbness (2415)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a l5-s1 tlif with a peek cage.Reportedly, the cage used was packed with allograft and bmp.Bmp was placed directly in the disc space prior to the insertion of the cage.Reportedly, sometime post-op, the patient developed severe back pain.The patient experiences daily, disabling pain that prevents him from performing many basic activities.
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Manufacturer Narrative
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Concomitant product: cage, allograft (implant (b)(6) 2009.(b)(6).(b)(4).Neither the device nor applicable imaging study films or patient medical records 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/used 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.
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Event Description
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It was reported that on (b)(6) 2012: per the billing records, the patient also underwent x-rays of cervical and lumbosacral spine.
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Event Description
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It was reported that (b)(6) 2009 patient reported low back pain and instability.Patient underwent ct of thoracic spine.Impression: negative thoracic spine.Patient underwent ct of lumbar spine.Impression: spondylolisthesis secondary to spondylolysis at l5-s1; mild scoliosis with apex to right at l5-s1.On (b)(6) 2009, patient reported low back pain.Patient underwent discography for a pre-op diagnosis of chronic low back pain, no radiculopathy; l5-s1 grade 1 spondylolisthesis; multi-level disc degeneration, l3-4, l4-5 and l5-s1; rule out disc mediated low back pain.Patient underwent ct of lumbar spine post discography.Impression: degenerative disc disease; spondylolysis l5 with grade 1 spondylolisthesis; laminotomy defect at the l5 level on right.On (b)(6) 2009, patient underwent fluoroscopically guided bilateral l5 pars blocks for diagnostic purposes; for a pre-op diagnosis of chronic mechanical right greater than left back pain, no radiculopathy; l5-s1 grade 1 spondylolisthesis with pars defects possibly symptomatic for mechanical pain; severe l5-s1 disc degeneration, moderate to severe l4-5 disc degeneration.Prior discography did not elicit pain.No complications were reported during the procedure.On (b)(6) 2009, patient reported left buttock pain and bilateral low back pain.X-ray showed optimal placement of fusion at l5-s1 vertebrae.No evidence of shift or recent trauma.On (b)(6) 2009, patient underwent ct of lumbar spine.Impression: hardware providing fusion to l5-s1 stabilizing an anterior subluxation due to spondylolysis at l5-s1.On (b)(6) 2010, patient reported symptomatic isthemic spondylolisthesis.Patient underwent ct of lumbar spine due to low back pain.Impression: no changes from prior study from (b)(6) 2009.Patient underwent x-ray of lumbar spine which showed increase in bone mass in tlif cage.No evidence of shift or loosening.On (b)(6) 2010, patient reported right sided back pain.Patient underwent x-ray of lumbar spine which showed instrumentation to be intact.There was no migration of tlif cage, no evidence of loosening and proximal visit was more medial than left.Patient underwent ct of lumbar spine.Impression: post-surgical changes at the lumbosacral level with associated subluxations unchanged since prior examination from (b)(6) 2010.
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Event Description
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It was reported that on: on (b)(6) 2007: the patient underwent ap lateral lumbosacral spine and pelvis x-ray.Impressions: mild possible spondylolysis of the l5-s1 vertebra with increased angle.Radiographically normal pelvis and hip films.On (b)(6) 2009: the patient underwent lumbar spinal mri.Impression: central anulus tear at l3-4; retro-subluxation at l4-5; spondylolisthesis secondary to spondylolysis at l5-51 with bilateral neural foramina narrowing at l5-51 causing impact to both the right and left l5 nerve roots.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on, (b)(6) 2012: patient presented for an office visit with chief complaints of sinus symptoms (chronic) and depression.Associated symptoms include difficulty breathing, headache, hoarseness, nasal congestion, nasal drainage, postnasal drainage and sinus pressure.The review of system revealed that the patient is positive for difficulty breathing and headache.On (b)(6) 2012: patient presented at dental office with complaint of cracked #8 crown.On (b)(6) 2012: patient presented with medication renewal request.
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Manufacturer Narrative
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(b)(6).(b)(4).
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Event Description
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(b)(6).The surgical approach used: transforaminal lumbar interbody fusion (tlif) and posterior lumbar interbody fusion (plif) patient reported that fractures in bones, which led to great instability over time led him to undergo rhbmp-2/acs treatment and got the surgery for pain management.Post-op rhbmp-2/acs treatment, patient alleged and still continue of having chronic pain and swelling at the fusion site, inflammation at the fusion site that causes stiffness in moving around, and numbness in his back and right side.Patient complained of having discomfort at all times with back pain and other symptoms continued after each surgery and got worsened over time.Patient reported that he's no longer able to participate in any physical activities like snowboarding, hiking, climbing.In year 2009-2010 and year 2012-2014, on unknown dates patient presented with diagnosis of back pain.For which patient also underwent for imaging studies.On (b)(6) 2015: patient underwent appendix removal procedure.On an unknown date patient underwent l5-s1 fusion.(b)(6) 2012: patient presented with dorsal left 3rd mcp joint pain, swelling and redness.Patient underwent left hand x-ray which showed no fracture or dislocation.Post splinting neurovascular exam was normal.Diagnosis: dorsal left 3rd mcp pain/swelling/erythema; strain vs cellulitis.(b)(6) 2012: patient underwent mendible x-ray due to pain and status post trauma.(b)(6) 2013: patient presented with complaints of fb/fb sensation to his right eye that started 2 days pta when he got something in his right eye while grinding metal underneath his car.Patient noted blurry vision to his right eye, right eye redeness and tearing.Diagnosis: right inferomedial (nasal) corneal foreign body/abrasion.Elevated blood pressure r/o hypertension.(b)(6) 2013: patient presented for eye check up.Patient reported improving redness, no swelling drainage or systemic symptoms.No visual blurring, only slight discomfort.(b)(6) 2013: patient underwent ct lumbar spine without contrast due to indications of back pain/previous surgery.(b)(6) 2014: patient underwent mr lumbar spine without gadolinium due to indication of lumbar radiculopathy.(b)(6) 2009 the patient underwent x-rays of the lumbar spine.(b)(6) 2009 the patient presented with the complaint of low back pain form l5-s1, isthmic spondylolisthesis.He also had deep discomfort within his pelvis as well as low back that worsens with bending forward.On examination, there was increased pain with forward flexion.On (b)(6) 2009: the patient presented with pre-op diagnosis of isthmic spondylolisthesis l5, s1 with low back pain.The patient underwent the following procedures: l5, s1 minimally invasive transforaminal lumbar interbody fusion wit placement of interbody peek cage, local body grafting and posterior l5, s1 transpedicular instrumentation mis system with a peek and rhbmp-2/acs were implanted during the procedure.Per the op notes, complete discectomy was performed, and a small packet of rhbmp-2/acs, one half of it was placed in the far end portion of the l5, s1 disk space.Then this was packed by several cubic centimeters of allograft.Then a 10 mm*26 mm peek cage which had one sixth of a small bmp packet also with allograft was placed in the disk space.Ap and lateral imaging demonstrated it as well positioned.Additional allograft was placed behind the cage.A 6.5*50 screw was placed into l5 and a 6.5*45 screw into s1.A 35mm lordotic rod was placed in the caudad and cephalad percutaneous direction through the screws and was tightened and locked in place to ensure the tlif cage would not back out into the canal.There were no apparent complications after the procedure.On (b)(6) 2009: the patient underwent -rays of the lumbar spine.(b)(6) 2009 the patient was discharged from the hospital.Final diagnosis: low back pain form l5-s1, isthmic spondylolisthesis.(b)(6) 2010 on a telephonic encounter, the patient stated that he continued to have pain in his right lower extremity.On (b)(6) 2010: the patient presented with the complaint of right sided low back pain despite previous l5-s1 spondylolisthesis operative management and left low back pain, numbness and tingling.The patient has elicited pain with lumbar extension.The ct scan reports indicate hardware impacting the facets joints, specifically at the l5 level.(b)(6) 2010 the patient presented with the pre op diagnosis of painful instrumentation, l5-s1; incomplete fusion, l5-s1.The patient underwent the following procedures: removal of right transpedicular instrumentation, l5-s1, with replacement of left l5 pedicle screw and revision of posterolateral fusion, l5-s1 with bmp and allograft bone.Per the op notes, on the left side, the transverse process of l5 and sacral ala were decorticated and a combination of 1/2 pack of a small bmp with 5 cc of allograft matrix was laid in to the lateral recess.Then on the right side, the transverse process of l5 and sacral ala were decorticated and other half of the bmp as well as 5 cc of demineralized bone matrix was placed into lateral recess.Intraoperative fluoroscopy was utilized.No patient complications were reported.On (b)(6) 2010: the patient presented with a history of revision of lumbar fusion hardware and underwent x-rays of the lumbar spine.(b)(6) 2010 the patient was discharged from the hospital.Final diagnosis: symptomatic right l5 screw causing right sided low back pain.
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Event Description
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It was reported that on (b)(6) 2012: the patient presented for follow up of injuries and for onset of respiratory infection.The patient continued with milder soreness of posterior neck and right hip.The patient had several days of nasal congestion; felt hot and cold first, had sinus pressure, sight cough.The patient reported chronic left greater than right nasal congestion.On (b)(6) 2013: the patient presented for follow up visit for back pain.On (b)(6) 2013: the patient presented for follow up visit for back pain at surgery site achy pain all day, right leg pain, stiffness when bending.On (b)(6) 2013: the patient presented for lab follow-up visit.On (b)(6) 2014: the patient presented with a chief complaint of ¿poss¿ splinter in right foot for 2 weeks.On (b)(6) 2014: patient also underwent x-ray of lumbar spine.Impression: successful fluoroscopy guided intrathecal contrast administration.There is grade 1 spondylolisthesis of l5 on s1.A moderate posterior disc bulge is seen at the l3/ l4 level.On (b)(6) 2014 per billing records, patient underwent ct scan of l spine post myelogram.Impressions: no significant neuroforaminal narrowing or spinal canal stenosis.Moderate bilateral neuroforaminal narrowing at l4-l5.Impressions: successful fluoroscopy guided intrathecal contrast administration.On (b)(6) 2014: the patient presented for follow up for low back pain and right leg pain.On (b)(6) 2014: the patient presented for follow up visit for worsening back pain.On (b)(6) 2016: the patient presented with low back and right leg pain.Patient¿s lower back pain was getting worse and chronic.Patient was also suffering from the following: radicular pain, posterior aspect of lower extremities of top of outer thigh, leg pain, pain localized to one or more joints upper and lower back pain, pain in between shoulder blades that was sharp and frequent, pain in low back radiating down the back of his right buttocks.The pain was sharp, shooting and constant and was worse when lifting his leg.The patient underwent frontal, lateral and spot view of the lumbar spine.Impressions: high suspicion of loosening of the left l1 screw.The patient underwent thoracic spine with swimmers views.Impressions: no acute findings.No fracture.Mild degenerative disc disease of the lower thoracic spine.
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