|
MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
|
Back to Search Results |
|
| Catalog Number 7510800 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Ossification (1428); Bronchitis (1752); Cyst(s) (1800); Dyspnea (1816); Headache (1880); Muscle Spasm(s) (1966); Muscle Weakness (1967); Neuropathy (1983); Pain (1994); Swelling (2091); Weakness (2145); Burning Sensation (2146); Tingling (2171); Dizziness (2194); Stenosis (2263); Depression (2361); Numbness (2415); Respiratory Tract Infection (2420); Neck Pain (2433); Neck Stiffness (2434); Paraplegia (2448); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
|
|
Event Type
Injury
|
|
Event Description
|
|
It was reported that the patient underwent a spine fusion surgery on the lumbar region of her spine from vertebrae l5 to s1 using rhbmp-2/acs.Patient's post-operative period was followed by a temporary period of relief and has subsequently been marked by increasingly severe radiating pain in her legs.Patient developed ectopic bone growth at the implant site.Patient continues to experience severe and unrelenting radiating pain in her lower extremities.
|
| |
|
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.Products from multiple manufacturers were implanted 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.
|
| |
|
Event Description
|
|
It was reported that on (b)(6) 2014 per billing records, patient underwent mri cervical spine and "joint of upper".On (b)(6) 2015 per billing records, patient underwent ct spine lumbar "w/ou" and x-ray of "lumbosacral min".
|
| |
|
Manufacturer Narrative
|
|
(b)(4).
|
| |
|
Event Description
|
|
It was reported that on on (b)(6) 2006 mri was reviewed which revealed early desiccation of l5-s1.She had about 9 mm paracentral disc herniation into the foramen with significant displacement of the s1 nerve root with some abutment of the l5 nerve root.On (b)(6) 2006 the patient presented with the following diagnosis: extruded disc.On (b)(6) 2006 the patient presented for follow-up and reported left leg pain and could not walk more than a block.Impression: 1.Recurrent disc herniation.2.Underlying spondylosis l4-s1.On (b)(6) 2006 the patient underwent mri of lumbar spine due to paraplegia lower limb/trauma.Impression: there was a left paracentral large extruded near free disc fragment at the l5-s1 level extending inferiorly behind the upper s1 vertebral body where it completely effaces the left lateral recess, involving the left s1 nerve root.On (b)(6) 2006 patient underwent x-ray lumbar spine.Impression: there was evidence of an l5-s1 disc spacer and pedicle screw placement at the l5 and s1 vertebral bodies; there was normal vertebral height and alignment; no acute art for complication was seen.On (b)(6) 2006 the patient underwent x-rays of lumbar spine due to lumbar radiculopathy, post-op.Findings: status post "orif" changes were visualized; bony position and alignment was satisfactory.On (b)(6) 2008 mri was reviewed which revealed no paracentral c5-6 disc herniation that does efface the hemicord as well as extend into the foramen.There was some early foraminal narrowing at c4-5.Discogram report was positive at both c4-5 and c5-6.On (b)(6) 2009 per billing records, the patient presented for an office visit.On (b)(6) 2009 patient underwent mri of the cervical spine.Impression: 1) a moderate left paracentral disc spur complex at c5-6 was causing mild compression of the left anterolateral spinal cord.No cord edema was present.There was also mild to moderate bilateral foraminal narrowing.2) mild disc spur complex at c6-7 without central canal stenosis.There was neural foraminal narrowing, mild on the right and moderate on the left.3) generalized disc desiccation throughout the cervical spine.4) 7 mm multiloculated right parotid cyst.On (b)(6) 2010 the patient stated the following medical problems: headaches, dizziness, blurred vision, cataracts, pain <(>&<)> stiffness in neck, sinus problems, shortness of breath, bronchitis, frequency of urination, aching <(>&<)> swollen muscles/joints, muscle weakness, fibromyalgia, numbness, difficulty in walking and depression.On (b)(6) 2012 patient presented for follow-up and reported neck pain radiating to the arms and low back pain radiating to the legs.Patient underwent xr lumbar spine.Impression: status post lumbar fusion; a s1 pedicle screw was broken and minimally displaced.On (b)(6) 2013 patient underwent x-ray of right thumb/hand.Impression: no acute process.On (b)(6) /2014 patient presented for follow-up and reported increased pain in the neck as well as across the low back, down both buttocks and both legs.On (b)(6) 2014 patient presented for follow-up on (b)(6) 2014 patient presented for follow-up and reported that her skin gets red and blotchy from the new generic oxycodone medicine.On (b)(6) 2014 patient presented for follow-up and reported increased pain.She got her medications refilled.On (b)(6) 2014 patient presented for follow-up and reported worsen neck pain.On (b)(6) 2014 patient presented for follow-up and reported fluctuations in her pain with the weather changes.On (b)(6) 2014 patient got hit on her right shoulder and right side of the neck and hence presented with complaints of increased pain.She underwent x-rays of the cervical spine and right shoulder, which determined that there were no fractures or dislocation and the cervical hardware appears stable.On (b)(6) 2014 per billing records, patient underwent mri cervical spine and "joint of upper".Impression: c5-7 acdf, c3-4 right bony foraminal stenosis, c4-5 3mm bulge and spur causing severe biforaminal stenosis, c7-t1 bulge.On (b)(6) 2014 patient reported that she continues to have right shoulder pain and had increased pain in the low back, near the incision site.On (b)(6) 2015 per billing records, patient for an office visit.On (b)(6) 2015 patient reported increased low back pain and weakness in bilateral legs.On (b)(6) 2015 patient presented for follow-up and reported that she continued to have pain in her right shoulder and neck.She also reported an upper respiratory infection.On (b)(6) 2015 patient presented for follow-up and reported that though her upper respiratory infection had been resolved, she was having some sinus issue.On (b)(6) 2015 patient presented for follow-up and reported increased pain in her back and legs.She had been having more difficulty in sleeping due to the pain.On (b)(6) 2015 patient presented for follow-up and got reviewed her medications.She reported increased pain and denied any new symptoms or medical problems.On (b)(6) 2015 per billing records, patient underwent ct scan head/brain; wo contrast.On (b)(6) 2015 patient presented for follow-up and reported increased pain in neck than the lower back and increased numbness in bilateral hands.On (b)(6) 2015 patient presented for follow-up and reported that her neck and lower back pain were adequately controlled.On 07/21/2015 patient presented for follow-up and reported that she had been experiencing more headaches, which she feels was attributed to the neck issues.She was ambulating with a cane due to increased pain, weakness and instability in her right leg.(b)(6) 2015 per billing records, patient underwent ct spine lumbar "w/ou" and x-ray of "lumbosacral min".Impression: slight anterior spondylolisthesis, bulging of the disc and hypertrophic changes of the posterior elements result in mild canal and bilateral foraminal stenosis at l3-4, grade 1 anterior spondylolisthesis, bulging of the disc and facet hypertrophy at l4-5.On (b)(6) 2015 patient presented for follow-up and reported right sided low back pain and burning that radiates into the right buttock and down the right leg.Patient underwent x-ray of lumbar spine which revealed l3-4 and l4-5 grade 1 anterolisthesis.On (b)(6) 2015 per billing records, patient underwent mri spine w/o contrast.Impression: bulging disc and facet hypertrophy on the left at t11-12 with significant left sided foraminal stenosis and probable left-sided nerve root impingement.Bulging disc and facet hypertrophy with mild bilateral foraminal stenosis at l3-4.Facet hypertrophy at l4-5 resulting in mild to moderate bilateral foraminal stenosis.On (b)(6) 2015 patient presented for follow-up and reported that she continued to experience low back pain that radiates into the right buttock and right leg.On (b)(6) 2015 patient presented for follow up and stated that her pain had been controlled well on the ms contin.She mentioned that she feels less depressed than she had been.On (b)(6) 2015 patient presented for follow up and stated that her pain had been controlled well on the ms contin.Ros revealed: numbness/ tingling arms/legs, decreased sleep, dropping things.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).
|
| |
|
Event Description
|
|
It was reported that on (b)(6) 2006 degenerative disc disease at l5-s1.2.Facet joint osteoarthritis.Pre-op diagnosis was extruded disc.She underwent l5-s1 laminectomy/discectomy.(b)(6) 2006: the patient underwent the following diagnosis: l5-s1 laminectomy/discectomy.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).
|
| |
|
Event Description
|
|
It was reported that on (b)(6) 2006 the patient presented for follow-up and reported severe left gluteal and leg pain.On (b)(6) 2006, the patient presented for follow-up and reported left leg pain and could not walk more than a block.On (b)(6) 2006, the patient underwent x-ray chest.Impression: normal examination.On (b)(6) 2006, the patient underwent x-ray lumbar spine.Impression: intraoperative marker.On (b)(6) 2006, the patient underwent l5-s1 hemilaminectomy and micro discectomy, left side.No complications reported.On (b)(6) 2006, the patient underwent x-ray lumbar spine 4 views.Impression: degenerative disc disease at l5-s1.Facet joint osteoarthiritis.The patient underwent the following procedures: l4-s1 revision decompression central and extraforaminal.L5-s1 posterior interbody fusion with hydrocele interbody cage and bone morphogenic protein.L5-s1 posteriolateral fusion with local bone graft and bone morphogenic protein #2.L5-s1 pedicle screw instrumentation with malibu pedicle screws.Procedure: dissection was carried out over l4-5 and l5-s1 facets to prepare the lateral recesses and expose the transverse processes for hemostasis, and deep retractors were placed.The central laminectomy of l5 was performed and inferior 1/2 of l4 was removed to adequately decompress centrally in the lateral recess.Using an osteotome, complete facetectomy was performed of l5-s1 to adequately decompress the lateral recess.After confirming adequate decompression of s1 nerve root, extraforaminal foraminotomies of l5 were performed bilaterally.An 8mm lordotic interbody cage was packed into disc space in oblique fashion and recessed 8mm with excellent interference fit.A slice of bmp sponge was placed in the mid portion of the cage.6.5mm diameter pedicel screws were placed in l5 and s1.45mm pedicle screws were placed in l5 and 40mm screws were placed in s1.Lateral x-ray confirmed position of cage and screws.Appropriate sized rods were cut and contoured and placed on multi axial screws.Locking nuts were placed and final tightening was performed.Bmp was wrapped around local bone graft and placed in lateral gutters.Fascial layer was closed with sutures and staples.Patient was taken to recovery room in stable manner.No complications were reported.Patient underwent x-ray lumbar spine.Impression: post spinal fixation.On (b)(6) 2007, the patient presented for follow-up and reported cervical and leg pain.On (b)(6) 2007, the patient presented for follow-up and reported leg pain.On (b)(6) 2008, the patient presented for follow-up and reported persistent cervical radiculopathy.On (b)(6) 2010, patient presented for follow-up and reported neck pain radiating into her arms and mid thoracic back pain radiating around the left side of rib cage.On (b)(6) 2010, the patient underwent mri thoracic spine.Impression: herniated disk at t7-8.2.Alt and disks at t3-4, t10-11, t11-12.3.Left sided foraminal stenosis at t11-12 in part due to facet hypertrophy.Patient also underwent x-ray lumbar spine.Impression: status post spinal fusion.No acute process.Patient also underwent ct lumbar spine.Impression: limited multifactorial canal stenosis at the l2 common l3 and l4 levels.Transpedicular stabilization and fusion of the l5 and s1 bodies.There is a metallic intradiscal prosthesis which appears in good position.Patent midline laminectomy at l5.Patient presented for follow-up and reported neck pain radiating into her arms.On (b)(6) 2010, the patient underwent the following procedures: anterior c5-c6 and c6-c7 decompressive diskectomies with decompression of spinal cord and exiting nerve roots with foraminotomies bilaterally.Anterior c5-c6 and c6-c7 interbody arthrodesis.Preparation of iliac crest structural allograft for arthrodesis.Placement of c5, c6, c7 cervical plate instrumentation.Patient also underwent single spine view x-ray.Impression: localization x-rays as described above.No complications were reported.On (b)(6) 2010, patient underwent x-ray spine, two views.Impression: status post spinal fusion.No acute process.Patient presented for follow-up and reported some pain in lower back and pain in neck and across shoulders.On (b)(6) 2010, patient presented for visit and reported back and neck pain.On (b)(6) 2010, patient underwent x-ray spine-cervical ap <(>&<)> lat.Impression: status post spinal fusion.No acute process.On (b)(6) 2010, patient underwent x-ray spine-cervical ap <(>&<)> lat.Impression: the cervicothoracic junction is not visualized on the lateral view due to overlying soft tissues.Previous c5-c6 and c6-c7 anterior interbody arthrodesis with intact appearing surgical hardware.On (b)(6) 2010, the patient underwent x-ray cervical spine.Impression: status post spinal fusion.No acute process.Patient presented for visit and reported spasms in left leg.On (b)(6) 2010, patient underwent mri lumbar spine.Impression: bulging disk and facet hypertrophy on the left at t11-12 with significant left-sided foraminal stenosis and probable left-sided nerve root impingement.Bulging disk and facet hypertrophy with mild bilateral foraminal stenosis at l3-4.Interval resolution of bulging disk at l4-5.There is facet hypertrophy at this level resulting in mild to moderate bilateral foraminal stenosis.Status post lumbar laminectomy and fusion at l5-s1 with mild bilateral foraminal stenosis.There is a mild amount of enhancing scar tissue along the margins of the thecal sac and in the left lateral recess.On (b)(6) 2010, patient underwent x-ray cervical spine.Impression: status post spinal fusion.No acute process.Patient presented for follow-up and reported some pain.Patient presented for a visit.On (b)(6) 2010, the patient underwent ct cervical spine.Impression: there is no ct evidence of acute traumatic injury to the cervical spine.C5-c7 anterior spinal fusion with bone grafts with minimum posterior spurring and minimal neural foraminal narrowing at these levels.Heterogenous thyroid lobes probably representing small thyroid nodules and better evaluated by ultrasound.On (b)(6) 2011 ,the patient underwent mri thoracic spine.Impression: mild degenerative disc disease most pronounced at t7-8 with a shallow disc protrusion.There is no spinal stenosis.No cord signal abnormality demonstrated.On (b)(6) 2012, the patient underwent x-ray spine cervical comp with oblique.Impression: status post fusion.No acute process.Patient also underwent x-ray knee complete left.Impression: status post lumbar fusion.On (b)(6) 2012, the patient underwent mri lumbar spine.Impression: 1.T11-12 disc osteophyte complex causes mild mass effect on the thecal sac.2.L3-4 shallow disc osteophyte complex mildly flattens the thecal sac but does not cause significance spinal canal narrowing.There is lateral mass effect also noted secondary to facet arthropathy and right greater left ligament flavum hypertrophy.Left ligamentum flavum hypertrophy at l4-5 contributes to mild dorsal lateral mass effect on the thecal sac.Stable postsurgical changes.Moderate left and right foraminal narrowing noted at l5-s1.On (b)(6) 2012, patient presented for follow-up and reported neck pain radiating to the arms, numbness in arms and low back pain radiating to the legs.On (b)(6) 2012, the patient underwent mri cervical spine.Impression: post surgical changes described above are unchanged from the prior examination.Spur-disc complexes appreciated c4-5 and c5-6 with mild mass effect on the ventral thecal sac with no significant spinal canal narrowing.Mild foraminal narrowing is redemonstrated at c5-6 secondary to uncovertebral joint arthropathy.The patient also underwent mri cervical spine.Impression: t11-12 disc osteophyte complex causes mild mass effect on the thecal sac.2.L3-4 shallow disc osteophyte complex mildly flattens the thecal sac but does not cause significant spinal canal narrowing.There is lateral mass effect is also noted secondary to facet arthropathy and right greater left ligamentum flavum hypertrophy.Ligamentum flavum hypertrophy at l4-5 contributes to mild dorsal lateral mass effect on thecal sac.Stable post surgical changes.Moderate left and mild right foraminal narrowing noted at l5-s1.On (b)(6) 2012, patient presented for follow-up and reported neck pain radiating to the arms and low back pain radiating to the legs.Patient underwent xr lumbar spine.Impression: status post lumbar fusion.Patient also underwent ct lumbar spine.Impression: postop l5-s1 appears to be completely fused posterior laterally with bony fusion.Pedicle screw fixation and metallic fusion spacer at the disc space also noted.Wide laminectomy and patent canal.Laminectomy l4-5 is patent as well.Moderate stenosis l3-4 secondary to ligamentum flavum, facet and bulging disc changes.On (b)(6) 2012, patient presented for follow-up and reported neck pain radiating to the arms and low back pain radiating to the legs.On (b)(6) 2012, patient underwent x-ray spine cervical.Status post lumbar fusion.No acute process.Also underwent x-ray knee left.On (b)(6) 2013, patient presented for follow-up and reported neck pain radiating to the arms and low back pain radiating to the legs.On (b)(6) 2013, patient presented for follow-up and reported low back pain and neck pain.On (b)(6) 2013, patient presented for follow-up and reported low back pain radiating to the legs.On (b)(6) 2013, patient presented for follow-up and reported controlled low back pain.On (b)(6) 2013, patient presented for follow-up and reported neck pain radiating to the arms and low back pain radiating to the legs.On (b)(6) 2013, patient presented for follow-up and reported neck pain radiating to the arms and low back pain radiating to the legs.On (b)(6) 2013, patient presented for follow-up and reported a fall due to leg giving out.On (b)(6) 2013, patient presented for follow-up and reported neck pain radiating to the arms and low back pain radiating to the legs.On (b)(6) 2013, patient presented for follow-up and reported stable neck pain radiating to the arms and low back pain radiating to the legs.On (b)(6) 2013, patient presented for follow-up and reported neck pain radiating to the arms and low back pain radiating to the legs.On (b)(6) 2013 patient presented for follow-up and reported fluctuating neck pain radiating to the ar,ms and low back pain radiating to the legs patient underwent x-ray right hand.Impression: no acute process on (b)(6) 2013, patient presented for follow-up.On (b)(6) 2014, patient presented for follow-up and reported fluctuating neck pain radiating to the arms and low back pain radiating to the legs.On (b)(6) 2014, patient presented for follow-up and reported increased neck pain radiating to the arms and low back pain radiating to the legs.On (b)(6) 2014, the patient underwent mri cervical spine in sagittal and axial planes.Impression: body foraminal stenosis on the right at c3-4.Broad-based herniation with cord impingement comment mild to moderate canal.Severe left and moderate to severe right sided foraminal stenosis at c4-5.This appears somewhat more pronounced than the prior study.Postoperative changes at c5-6.Mild bulging of the disc and bony spurring at c7-t1 and c7-t1 with mild left sided foraminal stenosis.Patient also underwent mri lumbar spine.Impression: herniated disc at t10-11 with canal stenosis.Bulging disc and facet hypertrophy on the left at t11-12 with significant left sided foraminal stenosis and probable left- sided nerve root impingement.Bulging disc and facet hypertrophy with mild bilateral foraminal stenosis at l3-4.Facet hypertrophy at l4-5 resulting in mild to moderate bilateral foraminal stenosis.Status post lumbar laminectomy and fusion at l5-s1 with moderate right and mild left sided foraminal stenosis.There is a mild amount of enhancing scar tissue along margins of the thecal sac and in the left lateral recess.On (b)(6) 2014, patient presented for follow-up and reported controlled neck pain radiating to the arms and low back pain radiating to the legs.Patient underwent fusion surgery with plif approach, where bmp was in cage and bmp and posterolateral fusion l5-s1 with bmp in bilateral gutters currently patient complained of leg pain, inability to walk, nerve injury; weakness and numbness in legs; worsening severe pain; inability to walk straight; and inability to sit or lay for long periods of time, trouble sleeping; and depression on (b)(6) 2006: patient was admitted for major back surgery.On (b)(6) 2010: patient underwent acdf (no rhbmp-2/acs).
|
| |
|
Manufacturer Narrative
|
|
If information is provided in the future, a supplemental report will be issued.
|
| |
|
Search Alerts/Recalls
|
|
|
