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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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| Catalog Number 7510800 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Failure of Implant (1924); Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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X- ray review results:ap & lateral post operative image from thoraco pelvic fixation provided no hardware failure is evident on these images.Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Note: there was no alleged malfunction with the product.The report is being filed for notification purposes.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that on: (b)(6) 2017: the patient underwent anterior lumbar interbody fusion at l5-s1 and revision posterior lumbar instrumented fusion, t10 to pelvis, with use of bmp due to pseudoarthrosis l5-s1, status post previous transforaminal lumbar interbody fusion and adjacent level fixation.Intra-operatively lateral fluoroscopy was taken to verify the level.After that was done, an anterior annulotomy was performed and the remaining l5-s1 disk was removed in a piecemeal fashion using a combination of curette and curette and kerrison.We noted hat on the ct scan, as well an intra-operative clinically, that the interface between l5 inferior endplate and graft was fused.There was pseudoarthrosis, was mainly at the s1 and allograft interface.We were able to remove the allograft successfully.Then we used a curate to smooth out and remove any fibrous union at the endplate of s1 and l5.The remaining disks left over from the previous tlif was clear to the posterior anulus.After preparation of the endplate, a small and medium cage was trialed.They felt the small was appropriate size, and a small packed with a small packet of bmp and the chipped allograft was then gently impacted into the l5-s1 disk space.The gutters of the cage was further packed with allograft as well.After the allograft was placed, intraoperative ap and lateral x rays were taken and the metal cage was felt to be in satisfactory position.Again, a time-out was then performed to confirm our second part of the procedure, which is a revision t10 to pelvis instrumentation.A longitudinal scar was made over the lower thoracic to the pelvic area in the midline through the previous scar.The previous scar was then slowly incised and careful hemostasis was achieved until exposure of the rod as well as the screw head on both sides.They were able to remove the rods bilaterally without difficulty as well as the set caps for the screw itself.They then explored the pedicle entry area on the right side of l5 level.Using a series of reduction clamps, they were able to contour around and replace the rods on both sides.All the subcapsular were secured and torqued with appropriate force.Final x-rays were taken.The anterior cage as well as the new rods were contoured with appropriate lumbar lordosis.All the screws appeared to be well fixed within the pedicles.On (b)(6) 2017: the patient went for follow up visit with leg pain and admitted due to pelvis bone graft done on (b)(6) and hardware removed from lower back on same day.Pain radiating from thigh to calf.Difficult to stand due to increase pain, swelling and tenderness.On (b)(6) 2017: the patient went for follow up visit.The diagnosis were: status 2 weeks post anterior lumbar fusion l5-s1 and revision for pseudoarthrosis.Lumbar x-ray from (b)(6) 2017.Findings were: two views of the vertebral column were performed while the patient was upright for scoliosis survey.Vertical rods from t10-s1 posterior instrumented fusion.There are also bilateral iliac screws present.The hardware has been revised since (b)(6) 2016.Disc spacers are again seen at l2-3, l3-4 and l4-5 disc spaces, unchanged in position and orientation since (b)(6).Anterolisthesis at the c4-5 level is also unchanged since that study.Lumbar lordosis measures approximately 57 degrees.T1 spinopelvic inclination measures -5 degrees.There is new minimal right basilar atelectasis since (b)(6) 2016.Scoliosis view radiograph.Findings were : upright standing ap and lateral spine view scoliosis series were provided.On (b)(6) 2017: the patient went for follow up visit and the diagnosed with post anterior lumbar fusion l5-s1 and revision for pseudoarthrosis.Her leg pain was resolved.Numbness over the anterolateral aspect of the thigh and left side is still lingering.She had developed some left side trochanteric bursitis that is tender to palpitation.X-ray demonstrates that patient has intact interbody at l5-s1, no signs of loosening.Overall, hardware is intact.(b)(6) 2017: the patient was diagnosed with underwent a two day anterior-posterior decompression and fusion for degenerative lumbar scoliosis on (b)(6) 2014.Multiple level direct lateral interbody fusion l2-l4 with transforaminal lumbar interbody fusion.Left l5-s1.Currently has symptomatic pseudo arthrosis l5 and s1 with bilateral broken rods.She underwent 2 stage anterior posterior revision for l5-s1 pseudarthrosis with l5-s1 alif and revision screw and rod instrumentation.She had a successful front and back surgery for her degenerative scoliosis.She had done well until developing symptomatic pseudoarthrosis at l5-s1 with resultant fracture and bone loss.Recent ct confirms that she is fused from l5 in a cephalad direction, but there is no evidence of fusion at l5-s1, bilateral s1 screws.She has become increasingly debilitated with both back and bilateral lower extremity pain and was finding it increasingly difficult to stand with a stance of being pitched forward.Her x-ray confirm that she has kyphosis through the l5-s1 disk in a standing posture with gapping of the rods posteriorly.On (b)(6) 2018: the patient underwent scoliosis/2 view examination.The findings were: two views of the vertebral column were performed while the patient was upright for a scoliosis survey.There are bilateral pedicle screws joined by vertical rods from t10-s1 posterior instrumented fusion with bilateral iliac screws.Note was made of disc spacers within the l2-3 through l5-s1 disc spaces.There is a grade 1-2 anterolisthesis at the c4-5 level.This is unchanged dating back to (b)(6) 2016.A grade 1 anterolisthesis is seen at l3-4 level, stable since (b)(6) 2017.No new spinal malalignments are identified.No new fracture is seen in the vertebral column.The patient has got some pain towards the left upper area of her thoracic spine at the location of top-most screw.She has 5/5 strength in bilateral lower extremities.She has exquisite tenderness to the greater trochanter bilaterally, left worse than right.Upright scoliosis x-ray the hardware is intact.The l5-s1 cage is well aligned.On (b)(6) 2018: the patient underwent rad/abd multi 3 views due to abd pain.The findings were: cholecystectomy clips right upper quadrant.Thoraco lumbar internal fixation multilevel intervertebral disc spacers at l2-s1 unchanged.On (b)(6) 2018: the patient was diagnosis with revision anterior/ posterior surgery for pseudoarthrosis l5-s1 (b)(6) 2017.Fracture left rod at l5-s1.Query pseudoarthrosis.Recent e-coli septicemia secondary to pancreatitis.Need to rule out infection.She had shooting pain in her low back radiating to her legs.Her pain persisted in her back.In (b)(6) 2017 her x-ray that looked everything was solid.Findings of x-ray were rods and pedicle screw spine fixation hardware is again seen from t10-s1 with bilateral iliac screws.A suspected defect in the left fixation rod at the level of l5/s1 is seen, with a history of a instrumentation fracture.On (b)(6) 2018: the patient went for follow up visit.Findings were: the diagnosed to add fixation right l5.Issue with the notching or contouring of the rod, then may be changing out the screw to multiaxial screws would allow positioning of the rod with less contouring.It would be highly unusual for an anterior lumbar interbody device with allograft and bmp not to fuse.Ct scan and gallium scan to exclude infection as soon as these imaging are done.On (b)(6) 2018: the patient went for follow up visit and the diagnosed with status one year lumbar interbody fusion, l5-s1 and revision posterior instrumented lumbar interbody fusion, t10 to the pelvis for pseudoarthrosis at l5-s1.Prior anterior posterior combined fusion for degenerative scoliosis, 2014.Currently has bilateral fractured rods at l5-s1 secondary to pseudoarthrosis despite alif.Recent crp gallium scan and ct reassuring for no evidence of infection.She had a non-union thereafter her first surgery because she did not have an interbody device or an interbody fusion done at that level with her first surgery.Her hardware has come loose and she has segmental fixation absent a single screw at l5 with an anterior cage.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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.
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Event Description
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18 mar 2014: as per the op-notes, ¿#10 scalpel blade was then used to cut through dermis.The bovie monopolar cautery was then used to cut all the way down to the fascia of the external oblique.The fascia of the external oblique was then cut through with the cautery.The external oblique was then dissected through until the fascia of the internal oblique was seen.This was also dissected through.We then saw the fascia of the transversus rectus.We then stimulated this with the nim probe to make sure there was no important nerve passing through.We found an area where there were no important structures.This was then dissected through with our finger.We then used our fingers to undertake dissection along the anterior aspect of the psoas muscle.We then used a nim probe to stimulate the psoas to make sure there were no important structures passing above it.With the help of intraoperative imaging, we then started at the l4 and l5 disc space.We made sure that our nim probe was well localized in the middle of the disc space.Once we were s atisfied that we were well localized, we then pierced the annulus with the nim probe.We then used a mallet to push the nim probe even further into the disc space.We then confirmed the localization of the njm probe with imaging.Once we were satisfied with the placement of the probe, we then placed our k-wire.This was confirmed under imaging again as well.Once we were satisfied with the position of the k-wire, we then removed the other sheath of the nim probe.We then used the dilators to dilate away the psoas muscle overlying the disc space.The placement of these dilators was confirmed with imaging.We then used the tubular retractors to keep our incision open.We then used a nim probe again to confirm the placement for placement of the screw into the vertebral body.We then used a 12 mm screw into the body.The nim probe was then used to stimulate over the disc space to make sure that there were no important structures passing above it.Once we were satisfied there were important structures, we then used electrocautery to remove any muscle overlying the disc space.The #15 scalpel blade was then used to cut through the annulus.We then used a combination of the pituitary rongeur, as well as the kerrison rongeurs to undertake the discectomies.We also used a combination of osteotomes and curettes to prepare the disc space.We used a series of dilators as welt under fluoroscopic imaging to help us dilate the disc space.We then used a trial starting at bx 45 mm in length.We then used the 10 x 45.We then used the 10 x 55 mm.Finally, we decided to use the 12 x 55 mm length spacer.The spacer was filled with bmp, as well putty.We then placed the spacer under direct imaging.Once we were satisfied with placement and imaging, we then removed the tubular retractors.We then focused on the next 2 levels.They were done in a similar fashion.At the l3-4 level, we placed a 10 x 50 mm spacer that was filled also with bmp and putty.At the l2·3 space, we placed a 10 x 45 mm spacer that was also filled with bmp and putty.We made sure that at each level there was no loss of amplitude or increase of latency from an electrophysiologle monitoring aspect.Throughout the procedure, there were no complications of the neural monitoring aspect.We then confirmed placement of the spacers on the anterior, posterior, and lateral imaging.Once we were satisfied with the placement of the spacer, we attempted to place our probe at the l 1-l2 level; however, this was not feasible due to the muscles that were present.As such, we decided not to place a spacer at that level.We irrigated the incision with saline solution.We ensured that there was adequate hemostasis of the muscles.We then reapproximated the fascia of the rectus abdominis muscle with #1 vicryl.The fascia of the external oblique was then reapproximated using #1 vicryf as well.We also reapproximated the muscles of the external oblique as well.The skin was then reapproximated using 2-0 vicryl.A 4-0 monocryl was used afterwards.The patient was extubated and brought in stable condition to the post-anesthetic care unit.¿.
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