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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

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MEDTRONIC SOFAMOR DANEK; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR Back to Search Results
Device Problem Break (1069)
Patient Problems Bone Fracture(s) (1870); Pain (1994); Disability (2371)
Event Date 06/10/2014
Event Type  Injury  
Manufacturer Narrative
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.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 on: (b)(6) 2014: the patient presented with preoperative diagnosis of lumbar spondylosis and stenosis and degenerative scoliosis.The patient had 10 years of back pain and complained of shooting pain down his both legs recently.He underwent the following procedure: an l3-l5 minimally invasive posterior lumbar interbody fusion utilizing interbody devices at both levels as well as pedicle screw instrumentation from l3-l5, also utilizing fluoroscopy, the o-arm and operating microscope.As per the op notes, ¿¿ at the l3-4 disk space on the right side¿ an interbody device was tapped into place.Unfortunately, as it was being tapped into place, it did appear to break; however, we got some c-arm images at this point and did not appear that any of the devices in the canal, some of it appeared to be in the endplate and it was actually moreover on the left side.All the metallic markers appeared to be in the endplate and it was actually moreover on the left side.All the markers appeared to be outside of the canal and over on the left side¿ attention was then turned to the l4-l5 disk space¿ a peek cage was put into place and it was filled with morcellized allograft, specifically demineralized bone matrix mixed with calcium granules.Once an appropriately sized device was found, it was tapped into place.As it was being adjusted, the underside of the dura was torn at this level.This was repaired using a piece of duraform which was laid under the nerve root as well as some fibrin glue.Attention was then turned back to the l3-l4 level.A different device was put into place and it was also filled with the same material.This appeared to be in better position¿ fluoroscopy images were then used to confirm good placement of the hardware¿¿ the patient also underwent ct scan of lumbar spine due to possible epidural hematoma post l3-l5 fusion.Impression: there is hyperdense material within the lateral recess adjacent to the l3 vertebral body within an angular margin.This is adjacent to several hyperdense clips/marker.This is most likely broken graft within the left lateral recess.An epidural hematoma is considered unlikely given its angular margins.While in the recovery room, the patient had good strength in his proximal lower extremities, but had essentially no dorsiflexion or plantarflexion and he severely decreased sensation in both his feet.Post-op ct scan revealed a triangular wedge of a relatively radiolucent material at the immediately superior to the l3-l4 disk space level, more so on the right side.This corresponded to the broken interbody device that was recognized during the original case, however, the intra-operative o-arm spin after the hardware was placed during the first case did not show any graft material in the canal.Operation 2: the patient had the following pre-operative diagnosis: status post l3-l5 fusion with new onset of neurological deficit and broken hardware.He underwent the following procedure: minimally invasive hemilaminectomy at l3-l4 on the left side for decompressive of the thecal sac and removal of broken hardware utilizing fluoroscopy and operative microscope.As per the op notes, ¿¿ we used a combination of high speed drill, kerrison and pituitary rongeurs and angled curets to remove all of the exposed peek cage that was visible.The underlying divot in the bone and the vertebral body of the l3 was also visible.After that, it appeared that the dural tube and the nerve root were free.It did not appear that there were any other fragments there¿ we used fluoroscopy again to confirm that we had a good decompression¿.The wound was closed¿¿ on (b)(6) 2014: the patient was noted to have bilateral lower extremity paresthesia and absence of motor function.He was further noted to have a large hematoma at the area of his right posterior surgical incision.On (b)(6) 2014: the patient underwent multiplanar, multisequential images of the lumbar spine due to posterior fusion at l3-l5 with back pain.Impression: there are recent postoperative changes which includes enhancement and abnormal signal intensity of the dorsal paraspinal muscles and enhancement within the epidural space at l3 and l4.L3 and l4 level central stenosis persist as does a left paracentral protrusion at l1-l2.On (b)(6) 2014: the patient was noted to have "hypergesia" in his left foot and was unable to move his toes or ankles.On (b)(6) 2014: the patient was admitted for acute inpatient rehabilitation due to post-op weakness of the distal lower extremities and positive bilateral foot drop.The patient continued to suffer from severe pain requiring opiate pain control, saddle anesthesia and neurogenic bladder requiring intermittent catheterization.On (b)(6) 2014: the patient had some difficulty with bowel movements.He continued to have sensation in his feet, but he also had some tingling sometimes.On (b)(6) 2014: the patient underwent ct and xr myelogram of lumbar spine due to postoperative lower extremity numbness and weakness status post l3-l5 fusion.Impression: 1.Successful lumbar myelogram performed at l2-3 puncture.2.New postoperative changes from left l3 hemilaminectomy with removal of retained interbody graft fragments.There is severe canal stenosis at l3-4 from combination of soft tissue or fluid and gas in space previously occupied by the graft fragment as well as right posterolateral impression from gas and fluid or soft tissue.It is unclear whether this represents gas in evolving postoperative scar tissue versus fluid collections or hematomas.3.Severe canal stenosis at l4-5 from combination of developmentally slender canal, broad disc bulge and facet and ligamentum flavum hypertrophy, as well as mass effect from liquid or soft tissue contained within right hemilaminectomy defect, with similar differential diagnosis to l3-4 findings.4.No significant change in moderate-severe canal stenosis at l2-3 from broad disc bulge and facet and ligamentum flavum hypertrophy with the developmentally slender canal.On (b)(6) 2014: the patient was discharged.On (b)(6) 2014: the patient was admitted with the pre-operative diagnosis of severe lumbar stenosis.The patient continued to have some levels numbness in his feet and his saddle region as well as some difficulties with urination.He underwent the following procedure: lumbar laminectomy for decompression at l2-3 and a lumbar laminectomy and partial facetectomy for decompression at l3-4 and l4-5.As per the op notes, ¿¿a midline incision was made from approximately the level of the l2-3 disk space down to the level of the l4-5 disk space¿ we removed the spinous processes and all the lamina as well down to the level of the l4-l5 disk space.We also removed the ligamentum flavum in a piecemeal fashion.There was some scar tissue, but we were able to remove it and free off the dura dorsally and lateral recesses all the way down to the l4-l5 disk space and somewhat beyond that given that a portion of the l5 lamina was removed as well.The dura appeared free.During the initial surgery, there was a small dural rent in the lateral recess at l4-l5 on the right side.This was inspected and appeared that the dural substitute was fairly adherent to the native dura, but there might be a tiny amount of csf seen.So, another piece of dural substitute was placed on top of this and evicel was placed on top of that.The remainder of the dura appeared intact everywhere and all the thecal sac appeared to be very free¿¿ postoperatively, the patient was noted to be in 10/10 pain.On (b)(6) 2014: the patient had abdominal distention, constipation, and a full bladder.Physical examination demonstrated no improvement in his weakness or absence of dorsiflexion/plantarflexion.On (b)(6) 2014: the patient reported 10/10 pain with no relief from oral medications and minimal relief from dilaudid.He was diaphoretic with pain.On (b)(6) 2014: the patient developed worsening numbness and tingling in both legs.On (b)(6) 2014: the patient presented for an office visit.Some improvement in sensation and his equina syndrome was noted but the patient still had very poor motor function in his dorsiflexion and plantar flexion.The patient remained hospitalized until (b)(6) 2014.He continued to require self-catheterization in the moving in order to urinate.He continued to be without ability to move his feet and weakness of his distal lower extremities.He was discharged with a diagnosis of incomplete paraplegia.On (b)(6) 2014: the patient underwent an emg study, which found evidence of acute bilateral lumbar polyradiculopathies affecting the muscles sharing the l4, l5, s1 myotomies.On (b)(6) 2015: the patient presented for evaluation.Post-operative ct scan was re-reviewed, which showed interbody devices at l3-l4 and l4-l5 with the interspace; an additional interbody device within the l3 vertebral body extending into the spinal canal, especially to the left of midline, impinging on the lateral recess.It was noted that the patient had no movement of the feet save for slight movement of the great toe with loss of dorsiflexion and plantarflexion bilaterally.There was weakness of the hamstring muscles and gluteal muscles bilaterally along with atrophy.Sensation was impaired to light touch and sharp stimuli in both lower extremities.There was numbness in a saddle distribution to the groin.Deep tendon reflexes were absent at the knees and the ankles.Currently, the patient is reported to be paraplegic and suffering from cauda equina syndrome.He is also reported to be totally disabled, in a wheelchair, with a neurologic bowel and bladder.
 
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Type of Device
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
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 Key6826284
MDR Text Key83834627
Report Number1030489-2017-01970
Device Sequence Number1
Product Code MAX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial
Report Date 08/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/07/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Disability;
Patient Age44 YR
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