|
MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
|
Back to Search Results |
|
| Catalog Number 7510400 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Ossification (1428); Abdominal Pain (1685); Cyst(s) (1800); Edema (1820); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Seroma (2069); Weakness (2145); Burning Sensation (2146); Tingling (2171); Hernia (2240); Stenosis (2263); Numbness (2415); Fibrosis (3167); No Code Available (3191)
|
|
Event Type
Injury
|
|
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) 2011 the patient underwent total disc displacement surgery using the anterior cervical fixation system and bmp.Reportedly, intra-op, patient's facet joint at the l5-s1 got fractured and the abdominal nerves were damaged due to which patient suffered significant abdominal pain, thigh pain and nerve damage.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).
|
| |
|
Event Description
|
|
It was reported that on: (b)(6) 2011 patient underwent alif l4-s1 and tdr l3-l4.On (b)(6) 2014 patient underwent postop visit for mri, ct scan.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).
|
| |
|
Event Description
|
|
It was reported that on (b)(6) 2011, the patient underwent total disc replacement surgery, using the device and bmp.Reportedly, the patient's abdominal nerves were damaged during the surgery.Postoperatively, there was bony overgrowth in patient's body and the patient experienced significant abdominal pain which became increasingly more severe, thigh pain and nerve damage-related issues.The patient had to undergo numerous treatments and surgeries to identify the source of the pain and treat patient's pain.The patient began to seek treatment from specialists, including gastroenterologists and pain management physicians.For several years, from approximately 2013 through 2015, patient underwent a series of tests and exams, including but not limited to colonoscopy, upper gi imaging, x-rays, ct scans, and ultrasounds of his abdomen, to attempt to determine the cause of his pain.The patient additionally underwent several surgical procedures, including but not limited to, hernia mesh implant and removal surgeries, to treat his pain.On or around (b)(6), 2014, the patient's primary pain management physician and surgeon performed a laparoscopic surgical procedure as a treatment for the patient's pain, where in the surgeon discovered and later informed the patient that his abdominal nerves may have been damaged during the (b)(6) 2011 procedure.On or about (b)(6) 2015, the patient underwent another surgery, wherein the surgeon discovered a portion of bmp overgrowth in the patient's abdomen.The patient's surgeon removed this overgrowth and advised the patient of this unnatural growth following the surgery.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).
|
| |
|
Event Description
|
|
It was reported that on: (b)(6) 2011 patient underwent alif l4-s1 and tdr l3-l4.Preoperative diagnosis: failed back syndrome, post traumatic pain syndrome, status post discectomy decompressions.Procedure: l5-s1 complete and radical discectomy.L4-5 complete and radical discectomy.L3-4 complete and radical discectomy.Distraction and realignment of disc space, l3-4, l4-5 and l5-s1.Arthrodesis, l4-5.Placement of prodisc, lumbar l5-s1.Placement of zuma interbody cage and zuma anterior, lumbar plate, made by cervical spine, l4-5.Placement of interbody device, l3-4.Use of intraoperative fluoroscopy.Use of extra small bmp and graft putty, l4-5.Per op-notes: "sequential distraction was performed and allowed for sequential distraction.The appropriate sized zuma interbody cage was then filled with part of a small bmp end graft putty, placed in a counter sign position at l4-5 and the appropriate." on (b)(6) 2011 the patient underwent muscle sparing anterior abdominal extra peritoneal approach for total disc replacement at l3-4 and l5-s1 and anterior lumbar spine fusion at l4-5.Preoperative diagnosis: degenerative disc disease, l3-4, l4-5 and l5-s1.On (b)(6) 2012 the patient was presented for office visit for one year follow up.The patient reported pain as aching, pressure, with burning sensation.On (b)(6) 2012 the patient was presented for office visit with burning in his feet bilaterally.Pain coming from l5-s1 foramen on the left hand side.On (b)(6) 2012 the patient was presented for office visit with severely disabled by both his low back pain which is localized to the l5-s1 region and buttock.In addition, he has a burning dysesthetic pain in his feet bilaterally.His aching, burning pain is aggravated by any activity including walking, standing and prolonged sitting.On (b)(6) 2012 the patient was presented for office visit with severely disabled and miserable from the pain.He has two areas of pain, one is burning pain in the soles of his feet bilaterally which is aggravated by any weight bearing activities improved by stretching and getting off his feet.The other one is localized mid lumbar pain with radiation to the left abdominal region.On (b)(6) 2013 the patient was presented for office visit with significant pain in his lower back with radiation into his left buttock.The patient reported pain also being present in his feet with numbness and a burning sensation compatible with neuropathy.On (b)(6) 2013 the patient was presented for office visit with pain.Pain is in the left ischial tuberosity region which could be compatible with a piriforms syndrome type pain complex.The patient underwent xrays which demonstrated no evidence of any significant scoliotic deformity.On (b)(6) 2013 the patient was presented fro office visit.Examination: he has evidence of significant palpation tenderness in the pirifoms region with reproduction of his symptoms by palpation.He has decreased sensation in the l4, l5 and s1 distribution bilaterally.On (b)(6) 2013 the patient was presented for office visit with left buttock pain which is aggravated by activity including standing or axial loading.Other than the left l5-s1 facet and neuroforaminal region of concern, the l3-4 disc has been placed in an ideal position, but gravity and core instability of his muscles, he has developed a slight rotation and a slight scoliotic deformity., however, the area around the artificial disc is calcifying and re-stabilizing this part if his spine.By exam, he has decreased sensation in his feet bilaterally.Range of motion results in exaggeration of his pain in extension which is limited to approximately 15 degrees.On (b)(6) 2013 the patient was presented for office visit with continued totally disabled for an undetermined period of time.On (b)(6) 2013 the patient was presented for office visit for emg and nerve conduction studies.On (b)(6) 2014 the patient was presented for office visit with back pain, which is aggravated by being in the erect position or even slightly flexed.On (b)(6) 2014 patient underwent postop visit for mri, ct scan.Impression: this demonstrated good positioning of his implant with no evidence of subluxations or implant failure.He continues to show good evidence of a fusion at l4-5.He ahs reasonable notion on flexion extension at l5-s1 and to a lesser extent at l3-4.His scoliotic deformity has remained stable and less than 10 degrees on the coronal plane centered at l3-4.On (b)(6) 2014 the patient underwent laparoscopic adhesiolysis.Laparoscopic bilateral inguinal hernia repair with mesh, tap.Pre operative diagnosis: left lower quadrant abdominal pain.Bilateral hernia.Possible inguinal hernia.Abdominal distension.On (b)(6) 2014 the patient was presented for office visit with abdominal bloating and abdominal pain in the left mid and left lower quadrant.On (b)(6) 2014 the patient underwent laparoscopic left groin mesh removal and exploration of retroperitoneal nerves.Left t11-l1 posterior cutaneous nerve transection.Intermediate level repair of skin and soft tissue.Preoperative diagnosis: chronic postoperative pain.Left lower quadrant abdominal pain.Meralgia paresthetica.On (b)(6) 2015 the patient underwent: robotic assisted laparoscopic left pelvic foreign body removal.Robotic-assisted laparoscopic left lateral fermorocutaneous and genitofemoral neurolysis.On (b)(6) 2015 the patient underwent: left retroperitoneal laparoscopic neurolysis x 4.Left retroperitoneal laparoscopic transection and release of fibrotic sheath.Left retroperitoneal laparoscopic excision of ossified mass.Preoperative diagnosis: chronic left lower quadrant abdominal pain.Heterotopic ossification.History of bmp implantation.
|
| |
|
Event Description
|
|
It was reported that on, (b)(6) 2012: patient underwent ct of lumbar spine without contrast.Impression: l3-4: there has been prior placement of a prosthetic disc with good alignment of the prosthesis.There is a right paracentral large spur unchanged compared to prior examination.There is no spinal stenosis or neural foraminal narrowing, unchanged from prior examination.L4-5: there has been prior anterior spinal fusion with solid bony fusion identified anteriorly.The fusion hardware is intact anteriorly.There is broad based posterior spur.There has been prior left hemilaminectomy.There is mild right lateral recess narrowing.No left lateral recess or left neural foraminal narrowing is seen.There is no spinal stenosis.These findings are unchanged compared to prior examination.L5-s1.Again noted is artificial disc placement unchanged compared to prior examination with no evidence of complications.There is no evidence of spinal stenosis or neural foraminal narrowing.There are also finding suggestive of prior left hemilaminectomy.Patient also underwent mri of lumbar spine without contrast.On (b)(6) 2012: patient presented with pre-operative diagnostic: right piriformis dystonia and right obturator intermus dystonia, for which the patient was administered a therapeutic botox chemodenervation injection.On (b)(6) 2012: patient presented for a follow-up evaluation.On (b)(6) 2012: patient underwent ct lumbar myelogram due to patient having bilateral burning in the feet intermittent lower extremity pains and weakness.Impression: the patient is status post artificial displacement at l3-l4 and l5-s1.At the l3-l4 level; there is significant anterior and lateralized osteophyte formation which is extending into the disk space.Solid fusion l4-l5.There is intraforaminal osteophyte formation of the lumbar spine but the exiting nerve roots are not truncated.In addition the central canal is not compromised.On (b)(6) 2012: patient presented with persistent postural headache status post myelogram on (b)(6) 2012.Patient underwent fluoroscopic guided blood patch.On (b)(6) 2013: patient underwent normal ct scan of the brain.Findings: the ventricles and sulci are of normal size and appearance.There are no focal brain parenchymal lesions, masses, mass effects or areas of hemorrhage.The brainstem and cerebellum are of normal size and appearance.There are no vascular calcifications noted.The orbits, base of skull and visualized portion of the proximal cervical spine are normal.Visualized portions of paranasal sinus are free of disease.On (b)(6) 2013: patient presented for a follow-up evaluation.On (b)(6) 2013: patient visited office with chief complaints of pain in his low back left buttock and left lower extremity.Patient also reported of the following problems: reflex sympathetic dystrophy of lower extremity, disorder of peripheral autonomic nervous system, facet joint pain, sacroiliac joint inflamed, sciatica, myofibrosis, acquired spondylolisthesis, degeneration of intervertebral disc.Patient presented with pre-operative diagnostic: left piriformis dystonia and 2) left obturator intermus dystonia, for which the patient was administered a therapeutic botox chemodenervation injection under fluoroscopic guidance.No intra-operative complications were reported.On (b)(6) 2013: patient presented for a follow-up evaluation.Reportedly, patient complained of pain in the low back located on the left side, which radiates down both lower extremes with weakness, numbness and burning in both feet.On (b)(6) 2013: patient underwent mri of pelvis with and without contrast due to persistent left butt pain suggesting piriformis syndrome.Impression: the piriformis muscles are symmetric without hypertrophy, atrophy or edema.The sciatic nerve on the left exits under the muscle without evidence of muscular penetration.The course of the sciatic nerve is well seen: there is no evidence of enlargement, perineural edema or abnormal gadolinium enhancement.Patient has changes in both hips suggestive of femoroacetabular impingement with mild articular cartilage damage.Postoperative changes of lumbar spine.On (b)(6) 2013: patient presented for a follow-up evaluation.Reportedly, patient complained of pain in the low back located on the left side, which radiates down both lower extremes with weakness, numbness and tingling.Patient also complained of left glut with radiation to left abdomen.Assessment: peripheral autonomic neuropathy, degeneration of thoracic or lumbar intervertebral disc; lumbar or lumbosacral intervertebral disc, sciatica.On (b)(6) 2013: patient presented with pre-operative diagnostic: lumbar radiculopathy, for which the patient was given an injection at left l5-s1 epidural steroid injection (esi).No intra-operative complications were reported.On (b)(6) 2013: patient underwent mri of the lumbar spine due to low back pain and lumbar radiculopathy radiating to left gluteal region.The patient complained of burning numbness and weakness in both legs.Impression: satisfactory appearance of artificial discs and fusions l3-l5 given that there is significant metallic artifact.There is no compromise of the neural elements.There has been no interval change compared to prior examination.On (b)(6) 2013: patient presented for a follow-up evaluation.On (b)(6) 2013: patient presented for a follow up.Patient complained of left lower back pain that radiates to the left glut and left abdomen with dull, pressure pulling aching sensation.Patient also complained of numbness to both feet with weakness.Patient was recommended for a sacroiliac joint injection for diagnostic purposes.On (b)(6) 2013: patient presented with pre-operative diagnostic: sacroiliac joint arthropathy, for which the patient was administered a sacroiliac joint steroid injection under fluoroscopic guidance.On (b)(6) 2013: patient presented with complaints of bilateral lower extremity pain, left side greater than right.Patient also complained of having burning feeling in both lower extremities.On (b)(6) 2013: patient presented with complaints of consistent left sided low back pain.Patient also complained of having pain in the left glut with radiation down the groin and abdomen.On (b)(6) 2013: patient underwent x-ray of lumbar spine (4 views: ap <(>&<)> lateral flexion extension).Result: the patient is status post intervertebral disk prosthesis placement at l3-4 as well as l4-5.There is no evidence of hardware fracture.No acute vertebral body compression fracture.No radiographic evidence of acute complication.On (b)(6) 2013: patient underwent ct of the abdomen and pelvis due to abdominal pain predominately left lower quadrant and left groin discomfort.Impression: there are no dilated loops of bowel and no evidence of mass, fluid collection, or inflammatory changes.A normal appendix is visualized.On (b)(6) 2013: patient presented with pre-operative diagnostic: lumbar facet arthropathy, for which the patient was administered a lumbar facet injection at left l5-s1 under fluoroscopic guidance.On (b)(6) 2013: patient presented for a follow-up evaluation.Assessment: acquired spondylolisthesis, degeneration of lumbar or lumbosacral intervertebral disc, reflex sympathetic dystrophy of the lower limb, peripheral autonomic neuropathy, sciatica, sacroiliitis.On (b)(6) 2013: patient presented with pre-operative diagnostic: lumbar facet arthropathy, for which the patient was administered a lumbar facet injection under fluoroscopic guidance.On (b)(6) 2013: patient presented for a follow-up post-injection.Patient complained of having minimum relief from injection, aching pain in lower back that radiated down left lower extremity to gluteus.Patient also complained of having constant burning sensation in feet.On (b)(6) 2013: the patient presented with a complaint of aching pain in lower back that radiates down left lower extremity.On (b)(6) 2014: patient presented for a follow-up visit.On (b)(6) 2014 patient presented for office visit.Assessment: constipation, outlet obstruction from back surgery.On (b)(6) 2014: patient presented for a follow-up visit due to abdominal pain.On (b)(6) 2014: patient presented with complaints of llq (left lower quadrant) abdominal pain and constipation.Patient underwent x-ray (with contrast) study of abdomen.Patient also underwent ct of abdomen pelvis (w contrast).Result: no bowel obstruction or other acute findings in the abdomen or pelvis.Moderate to large amount of stool throughout the colon.On (b)(6) 2014: per billing records, patient underwent mri of lumbar spine with and without contrast.On (b)(6) 2014: the patient presented for follow up for abdominal pain.On (b)(6) 2014, patient presented for office visit with complaint of abdominal pain.Assessment: abdominal pain: not constipated.On (b)(6) 2014: patient presented for a follow-up visit due to abdominal pain.On (b)(6) 2014: the patient presented for abdominal ultrasound injection.On (b)(6) 2014: the patient presented for post ultrasound injection.On (b)(6) 2014: the patient presented for evaluation of abdominal pain.On (b)(6) 2014: patient underwent x-ray of lumbar spine (4 views).The current study is compared with the previous examination of (b)(6) 2013.Result: the nearly circumferential peripheral fusion at l3-l4 was present previously.It is likely that at l4-l5 the fusion centrally is solid.There has been no change in the position of the hardware.Patient also underwent x-ray of thoracic spine (3 views) due to the abdominal pain in the left radiating to the left leg.Impression: unremarkable thoracic spine x-rays series.On (b)(6) 2014: the patient was pre-operatively diagnosed with left complex regional pain syndrome, abdomen.Left radiculopathy, lumbar and underwent the left l1-l2 and l2-l3 transforaminal epidural steroid injection.On (b)(6) 2014: patient underwent ct of lumbar spine ( w/o contrast).Comparison study was made with the previous mri lumbar spine dated (b)(6) 2014.Findings: disk prosthesis at the l3-4 level is in place.Disk prosthesis at the l5-s1 level is in place.Interbody fusion at the l4-5 level with ventral plate and screws are in place.Patient also underwent mri of lumbar spine ( w <(>&<)> w/o contrast).Impression: status post anterior interbody fusion at l3-4 through l5-s1, which makes evaluation difficult due to artifact.However, no significant abnormality is demonstrated, but the left l5-s1 foramen cannot be adequately evaluated.It may be stenosed, there being facet hypertrophic change at this level.This might be better detailed with ct.Artifact.However, no significant abnormality is demonstrated, but the left l5-s1 foramen cannot be adequately evaluated.It may be stenosed, there being facet hypertrophic change at this level.This might be better detailed with ct.On (b)(6) 2014: patient underwent mri of left hip post arthrogram.Impression: tear of the mid to cephalad portion of the anterior l xxxxabrum.Large os acetabulum at the cephalad portion of the anterior labrum.Fraying of the anterior to mid superior labrum.Severe cam deformity of the left femoral head/ neck junction but with mild superolateral left hip chondrosis.Findings of cam type femoroacetabular impingement of the right hip.Status post lumbar spinal fusion.On (b)(6) 2014: patient presented to ed with abdominal pain, attributed to hernia, for which, reportedly, he had undergone laparoscopic repair this past august.Patient got admitted for pain control.On (b)(6) 2014: patient who was admitted with pre-operative diagnosis: sympathetically mediated llq pain, underwent the following procedure: lumbar sympathetic nerve block (3 with the pain service), left lumbar level: l1/l2 under fluoroscopy.Reportedly, the patient tolerated the procedure well without any complication.On (b)(6) 2014: patient underwent intra-op x-ray imaging of left hip with pelvis.Findings: surgical hardware is seen at the lower lumbar spine.Small dysplastic bumps are present at bilateral femur head/neck junctions consistent with pistol grip morphology.There is no hip joint space narrowing.The pubic symphysis and visualized sacroiliac joint spaces are normal.No fracture is identified.A bone island is present in the right femoral head and stable.Focus of fibrocystic change in the left femoral head/neck junction is stable.Sub-centimeter sclerotic lesion in the superomedial left acetabulum likely represents a bone island.On (b)(6) 2014: patient underwent x-ray therapeutic injection left hip post arthrogram.Impression: contrast filled the joint space in a normal manner.On (b)(6) 2014: patient got discharged from the hospital.On (b)(6) 2014 patient presented for office visit with complaint of low back pain.Assessment: lumbago.Nerve root disorder.Nerve or musculoskeletal symptoms.Nerve injury.On (b)(6) 2014, patient presented for pain management follow up visit.On (b)(6) 2014: patient underwent a physical exam for a pre-operative clearance.Impressions: possible incisional hernia.History of hodgkin.History of coccidioidomycosis.On (b)(6) 2015: the patient presented for follow up for spine problem and medications refilling.On (b)(6) 2015: patient underwent mri of pelvis without contrast, due to left buttock and hip pain and concern for ischiofemoral impingement syndrome.Comparison study was done with the mri of left hip arthrogram from (b)(6) 2014.Impression: no finding to suggest ischiofemoral impingement stable findings of left hip osteoarthritis and cam deformity.On (b)(6) 2015, patient presented for pain management follow up visit.Assessment: lumbago.Nerve root disorder.Nerve or musculoskeletal symptoms.Nerve injury.On (b)(6) 2015, patient presented with following pre operative diagnosis: peripheral impingement of the anterior abdominal nerve with scarring of the nerve and abdominal adhesions.Procedure performed: lysis of adhesions of the abdomen under ultrasound guidance as well as anterior abdominal nerve ablation using chemical neurolysis with wydase and ropivacaine.On (b)(6) 2015: patient underwent mri of abdomen pelvis w/o contrast due to potential problem with hernia.Impression: abnormal appearance of the mesh in the left inguinal region with fat separating the mesh from the posterior rectus sheath as well irregular contour with areas of thickening and tenting of the mesh.No significant inflammation or meshoma.No recurrent hernia.Marked atrophy of the left rectus abdominis muscle.Postsurgical changes in the mid left anterior abdominal wall.No evidence of hernia at this site.On (b)(6) 2015: patient presented for a physical exam due to pain.On (b)(6) 2015: patient was diagnosed pre-operatively with: chronic postoperative pain, possibly due to mesh; left meralgia paresthetica; left genitofemoral neuralgia.Operative findings: mesh intact, flat; no hernia recurrence; heterotopic ossification with bony plate noted in left pelvis, at the level of the inguinal ligament; complete sheet-like compartmentalization of the retroperitoneum in space overlying lateral femoral cutaneous and genitofemoral nerves; 5.Intact lateral femoral cutaneous and genitofemoral nerves otherwise.On (b)(6) 2015: patient presented for consultation.Reportedly, he continued to have pain, which he described as a tightness and hardness in the left lower quadrant with pain radiating down to the thigh.On (b)(6) 2015: the laparoscopic video of the robotic procedure performed 3 weeks ago on the patient was reviewed.The doctors after analyzing the video and discussing among them decided that any further surgery would not only be at high risk but also would not alleviate the sensory and pain symptoms that the patient is experiencing.In addition, an open procedure would not have any advantage over what has been already done robotically.On (b)(6) 2015: patient presented for a physical examination due to pain.Patient underwent an ekg exam.Impression: cleared for abdominal surgery.On (b)(6) 2015: the patient presented for an office visit.On (b)(6) 2015: microscopic findings: sections reveal nerve with depleted numbers of myelinated fibers, subperineurial edema and presence of renaut bodies.On (b)(6) 2016: patient presented for a follow-up visit and underwent a physical examination.Impressions: fever, probable sinusitis.On (b)(6) 2016, patient presented for pain management follow up visit.Assessment: nerve injury.Genitofemoral neuralgia of left side.Hx of inguinal hernia surgery.On (b)(6) 2016: patient presented for a follow-up visit and underwent physical examination.Impressions: heterotropic ossification in the abdomen, status post multiple abdominal operations.Sinusitis on z-pack.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).
|
| |
|
Event Description
|
|
It was reported that on, (b)(6) 2011 patient underwent alif l4-s1 and tdr l3-l4 and l5-s1.Preoperative diagnosis: failed back syndrome, post traumatic pain syndrome, status post discectomy decompressions, degenerative disk disease, l3-l4, l4-l5 and l5-s1.On (b)(6) 2011: the patient underwent x-ray of lumbar spine due to back pain.Impression: surgical changes noted.On (b)(6) 2011: the patient presented with failed back syndrome as part of his diagnosis as he was involved in an injury that resulted in his symptoms.On (b)(6) 2011: the patient underwent mri of the lumbar spine without contrast due to pain.Impression: l3-l4: there is extensive metallic artifact seen anteriorly within the disc space.There are bilateral mild facet degenerative changes ligamentum flavum hypertrophy with no spinal stenosis or neural foraminal narrowing.L4-l5: there has been interval left hemilaminectomy.There are postsurgical changes within the disc space.There are bilateral neural foraminal broad based spurs as also seen on the prior exam.No central canal narrowing is seen.There is no left neural foraminal narrowing.There is mild right lateral recess narrowing.L5-s1: there is extensive metallic artifact seen anteriorly.There are findings suggestive of interval left hemilaminectomy.No evidence of spinal stenosis is seen.On (b)(6) 2011: the patient underwent mri of upper extremity without contrast due to pain.Impression: non specific increased signal in the supraspinatus and infraspinatus tendons, mild without definite imaging evidence of tear, compatible with tendinopathy.Associated small subacromial/subdeltoid effusion.Abnormality of the anterior lip of the glenoid labrum.Small subchondral cyst in the humeral head, likely degenerative.On (b)(6) 2011: per billing records patient underwent x-ray.On (b)(6) 2013 the patient was presented with continued left greater than right buttocks pain as well as numbness, tingling, burning, and pins and needles in both feet.The patient underwent x ray.Autofusion has occurred at l3-4, having converted this to a solid fusion.L4-5 appears to be a solid fusion and l5-s1 appears to be a midline centered prosthesis in good position but with probably superimposed facet arthropathy.Impression: significant facet arthropathy and consequent radiculopathy in the l5-s1 recess.On (b)(6) 2013 the patient was presented for office visit.Impression: diagnostic studies have been reviewed, which include act myelogram, ct scan.They are fairly non conclusive in regards to very obvious source of the patient's left sided buttock pain.The prosthesis appears to be well seated and symmetric.On (b)(6) 2013: the patient underwent lumbosacral spect scan due to low back pain.Impression: abnormal uptake at the l3-4 level, predominantly anteriorly and to the right of midline.No abnormality of the interbody device.Mild uptake is seen at the l5-s1 level on the left side.This appears to correspond to the left l5-s1 facet joints.The patient underwent whole body bone scan.Impression: mild degenerative pattern is seen in both acromioclavicular joints, both knee joints and both ankle joints.Abnormal uptake is seen at the l3-4 disc space level that is eccentrically greater to the right lateral margin.There are no correlative cross-sectional imaging studies available.On (b)(6) 2013: patient underwent radiographic examination.Impression: photogenic l3-4 and l5-s1 disc spaces corresponding to the disc replacements.Anterior right activity at l3-4 related to an osteophytic spur.Asymmetric increased activity in the inferior left sacroiliac joint.On (b)(6) 2013 the patient was presented for office visit.Imaging studies included a spect scan, which did show uptake at the left l5-s1 facet joints.On (b)(6) 2013 the patient was presented for office visit with left sided buttock pain, back pain, and leg pain and 8/10 was the analog pain description.Impression: the patient continued to present with an entirely failed surgical outcome after artificial disc replacement and fusion in a hybrid manner.His symptoms included a variety of symptoms including left buttock pain, sacroiliac pain, and abdominal pain.On (b)(6) 2013: per billing records patient underwent colonoscopy.On (b)(6) 2014: the patient underwent mri of lumbar spine due to severe low back pain, right foot drop for one to two months and burning in both feet.Conclusion: the interspaces at l4-l5 and above l3 are unremarkable.The ferromagnetic artifact due to anterior interbody fusion alloys at l3-l4 and l5-s1 are probably clear relative to neural foraminal encroachment.On (b)(6) 2014 and (b)(6) 2015 patient presented for office visit with complaint of bloating and abdominal pain.Problem list: irritable bowel syndrome with constipation.On (b)(6) 2014: patient came for follow up visit.On (b)(6) 2015, patient presented for office visit with complaint of bloating and abdominal pain.Problem list: irritable bowel syndrome with constipation.On (b)(6) 2015: patient came for review of his study.On (b)(6) 2016 the patient underwent whole body bone scan.Impression: mild degenerative pattern is seen in both acromioclavicular joints, both knee joints and both ankle joints.Abnormal uptake is seen at the l3-4 disc space level that is eccentrically greater to the right lateral margin.There are no correlative cross-sectional imaging studies available.The patient underwent lumbosacral spect scan due to low back pain.Impression: abnormal uptake at the l3-4 level, predominantly anteriorly and to the right of midline.No abnormality of the interbody device.Mild uptake is seen at the l5-s1 level on the left side.This appears to correspond to the left l5-s1 facet joints.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).
|
| |
|
Event Description
|
|
It was reported that on (b)(6) 2010: the patient was pre-operatively diagnosed with low back pain, lumbar radiculopathy and neurological deficits, recurrent herniated disc l3-l4, l4-l5 and l5-s1 and underwent unilateral microdecompression l5-s1 and l4-l5, unilateral l3-l4 microdecompression, with neurolysis of scar tissue l4-l5 and l5-s1, intra-operative use of monitoring, intraoperative use of microscope and intraoperative use of x-ray interpretation.On (b)(6) 2010: the patient underwent chest x-ray 2 views.Impression: vascular crowding both lung bases.
|
| |
|
Manufacturer Narrative
|
|
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) 2013: patient presented for ultrasound of abdomen due to left lower quadrant abdominal pain.Impression: no sonographic evidence for a bowel-containing abdominal wall hernia.A probable loop of bowel is seen deep to the area of pain in the left lower abdomen.On (b)(6) 2013: patient presented with electromyography and nerve correction study for evaluation of low back and lower extremity pain and numbness.Impressions: mild to moderate, chronic right l4-5 radiculopathy.On (b)(6) 2014: patient presented for a fluoroscopy of upper "gi" with contrast.Impression: no evidence of small bowel strictures or obstruction.On (b)(6) 2014: patient presented for an office visit due to lower left quadrant (llq) pain status post lumbar disc replacement (left lower abdominal pain).Patient underwent physical examination and review of systems which revealed no issues.On (b)(6) 2014: on same day, patient was underwent following diagnosis: left t12 posterior cutaneous nerve, resection; left t11 posterior cutaneous nerve, resection; left l1 posterior cutaneous nerve, resection due to mononeuritis of lower limb(lower left quadrant), chronic pain.Findings: sections reveal nerve with depleted numbers of myelinated fibers, subperineurial edema and presence of renault bodies.On (b)(6) 2015: patient presented for a follow-up visit due to post-op wound and seroma.On (b)(6) 2015: patient presented for a follow-up visit due to nerve block.Plan: left lateral cutaneous nerve block; follow up as needed for pain relief and evaluation of symptoms.On (b)(6) 2016: patient presented for post-op follow up visit due to post-op :laparoscopic removal of left retroperitoneal ossification and neurolysis.On (b)(6) 2016: patient presented for a follow-up visit.On (b)(6) 2016: patient presented with following pre-op diagnosis: left recurrent inguinal hernia; left groin pain; left genitofemoral neuralgia; left retroperitoneal calcification; complications from bmp; chronic postprocedural pain.Patient underwent following procedures: left genital branch and iliohypogastric peripheral neurectomies; left iliohypogastric nerve implantation into muscle; left inguinal hernia repair with mesh; left retroperitoneal release of fibrosis, adhesiolysis.Microscopic findings: left iliohypogastric nerve branch (biopsy): segment of unremarkable nerve branches; retroperitoneal tissue (history of calcification)(biopsy): fibroconnective tissue with focal foreign bodies; left genitofemoral nerve (excision): fibrovascular tissue with scant minute nerve twigs.On (b)(6) 2016: patient presented for a follow-up visit.On (b)(6) 2016: patient presented for a follow-up visit due to llq pain.Patient under an ultrasound therapy due to llq scar pain.
|
| |
|
Event Description
|
|
It was reported that on, (b)(6) 2011: patient underwent ct scan of the lumbar region.Impression: postoperative changes are present from prior posterior decompression with discectomy and interbody bone graft placement at l4-l5 with the hardware in good position and evidence of some degree of bony bridging involving the bone graft.Postoperative changes are present from intervertebral disc replacement at l3-l4 and l5-s1 with hardware in good position and no evidence of hardware complications.At l4-l5, there is mild right facet hypertrophy and residual right posterolateral bony spurring causing mild right neural foraminal stenosis and slight narrowing of the left neural foramen.At l5-s1, there is small residual posterior bony spurring and mild right facet hypertrophy causing slight narrowing of the right neural foramen.There is no significant spinal canal stenosis at any level of the lumbar spine.(b)(6) 2013: patient underwent x-ray of the lumbar region.Impression: normal sinus series.(b)(6) 2013: patient presented for office visit with a very complicated history after undergoing multiple lumbar surgeries.Orthopedic examination: there is mild discomfort with flexion and internal rotation.X-rays of pelvis with lateral hip views shoe early degenerative changes.Impression: early left hip osteoarthritis.Complex failed back syndrome.(b)(6)2014: patient underwent x-ray of the lumbar region.Impression: status post artificial disc replacement at l3-4 and ls-s1.Status post interbody fusion procedure at l4-5.No fracture, spondylolisthesis, or instability.Mild levoscoliosis of the lumbar spine.(b)(6)2014: patient presented for a follow-up visit for abdominal pain along scar line, exertion related foot drop, tingling and pain in bilateral feet and lateral hip pain.Physical examination revealed grimacing, reduced verbalization, guarded movements, limited mobility and stiff movements.Multiple mris reviewed show that there were post surgical changes in the l3-l4, l4-l5 and l5-s1 areas, consistent with previous surgery.There was significant ferromagnetic artifact at those levels and it was difficult to judge if there is new nerve root impingement.(b)(6) 2014: patient presented for a follow-up visit.Physical examination revealed decreased distension in the abdomen lately around the scar line.Patient underwent ultrasound in which no abnormalities were found.(b)(6) 2014: patient presented for consultation and evaluation.Impression: myofibrosis, facet joint pain.(b)(6) 2014: patient presented for consultation and evaluation: assessment: sciatica, facet joint pain, acquired spondylolisthesis, sacroiliac joint inflamed, disorder of peripheral autonomic nervous system, myofibrosis, reflex sympathetic dystrophy of lower extremity.(b)(6) 2014: patient presented for follow up of abdominal pain.Review of system: constitutional: fatigue.Assessment: abdominal pain left lower quadrant.Displacement of lumbar intervertebral disk, coccidioidomycosis, personal history of hodgkin¿s disease.
|
| |
|
Manufacturer Narrative
|
|
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) 2009: patient presented with pre-op diagnosis of l4-5 spinal stenosis and l5-s1 spinal stenosis.For which patient underwent l4-5 epidural steroid injection.(b)(6) 2009: patient underwent ¿emg¿ and ¿ncv¿ study.Impression: normal electrodiagnostic study of both lower limbs.There is no electrodiagnostic evidence of lumbar radiculopathy or generalized peripheral neuropathy.The minor abnormality in the asymptomatic right extensor digitorum brevis in the absence of other abnormalities does not warrant a pathologic conclusion (b)(6) 2010: patient underwent mri lumbar spine without contrast due to low back pain.Impression: no significant interval change compared to prior mri dated (b)(6) 2009 demonstrating following: l3-l4.Mild to moderate disc height loss with a 2-3 mm diffuse disc bulge.There is a mild-to- moderate spinal canal narrowing to 8 mm.Foraminal extension of the disc bulge renders mild -to-moderate right neural foraminal stenosis and mild left neural foraminal stenosis.L4-l5: moderate disc height loss with a 4 mm diffuse disc bulge.Moderate-to- severe left greater then right neural foraminal narrowing secondary to foraminal extension of the disc bulge.L5-s1: 3 mm broad-based disc protrusion causing narrowing of the lateral recess.The central spinal canal is patient.Foraminal extension of the disc protrusion renders mild to moderate left greater than right neural foraminal narrowing.There is mild to moderate disc height loss.
|
| |
|
Manufacturer Narrative
|
|
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) 2009: the patient underwent pet scan of skull to mid-thigh due to clinical history of lymphoma.Conclusion: interval development of hypermetabolic activity within the mediastum corresponding to adenopathy most consistent with tumor recurrence.Inflammatory etiology is possible, however distribution of adenopathy is not typical.Interval development of consolidation within the left lower lobe.Finding may be secondary to an inflammatory etiology or tumor recurrence.No other high suspicious areas are present to suggest tumor recurrence.On (b)(6) 2009: the patient presented with history of high fevers, night sweats, neck pain, severe muscle and joint aches.He complained of extreme fatigue for the last few days.He also had pain in ankles and feet bilaterally.He also had ambulation difficulties.On (b)(6) 2009: the patient underwent bone scan of whole body due to clinical history of lymphoma.Conclusion: normal exam.On (b)(6) 2010: the patient presented with fatigue.He also complained of slight hair loss on forehead.On (b)(6) 2010: the patient presented with weakness and was feeling lethargic.On (b)(6) 2010: the patient called as he was feeling very weak.He seemed to be severely fatigued.On (b)(6) 2010: the patient underwent ct of chest due to clinical history of lymphoma.Conclusion: single surgical clip in the upper mediastinum otherwise normal.On (b)(6) 2010: the patient underwent pet scan from skull to mid thigh due to clinical history of hodgkin¿s lymphoma.Conclusion: normal exam without evidence of hypermetabolic malignancy.Hypermetabolic mediastinal and hilar adenopathy seen in previous exam has disappeared.On (b)(6) 2010: the patient presented with back pain.On (b)(6) 2010: the patient presented for an office visit.He still felt fatigued.His dose of celebrex was increased from 100 mg/day to 200 mg/day.On (b)(6) 2011: the patient presented for an office visit.On (b)(6) 2012: the patient presented with severe pain in legs and bilateral neuropathic burning pain in feet.On (b)(6) 2012: the patient presented with back pain.On (b)(6) 2012: the patient¿s serology was slightly higher.On (b)(6) 2013: the patient presented with back pain.He also experienced lower extremity numbness, foot burning, severe lower back pain.On (b)(6) 2013: the patient presented with back pain.On (b)(6) 2013: the patient underwent colonoscopy due to abdominal pain and bloating.Impressions: normal terminal ileum.Stool in the cecum and ascending colon.Despite attempts at washing and suctioning, adequate views of these areas could be obtained.Visualized colonic mucosa was unremarkable.On (b)(6) 2014: the patient presented for an office visit due to back pain.On (b)(6) 2014: the patient presented with increased abdominal pain from his anterior spinal surgery.On (b)(6) 2015: per billing records, the patient underwent echo study of abdomen.On (b)(6) 2017: the patient presented as he had concussion and black-out for 1-2 seconds on the previous day due to hitting head on kitchen counter in a fall.The patient slight swelling near the top of the head.
|
| |
|
Search Alerts/Recalls
|
|
|
