|
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); Arthritis (1723); Diarrhea (1811); Dysphagia/ Odynophagia (1815); Headache (1880); Incontinence (1928); Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Swelling (2091); Urinary Tract Infection (2120); Vomiting (2144); Weakness (2145); Tingling (2171); Stenosis (2263); Injury (2348); Sweating (2444); Ambulation Difficulties (2544); Hematuria (2558); Weight Changes (2607); No Code Available (3191)
|
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
(b)(6).(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) 2008, patient underwent posterior lumbar interbody fusion surgery on the lumbar region of her spine from vertebrae l4 to s1.Reportedly, during the surgery,only select parts rhbmp-2 collagen sponge were used to fuse more than one level of the spine.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the posterolateral elements).Post-operative period had been marked by chronic lower back pain and associated radiculopathy in both lower extremities.She experienced difficulty sitting, standing and walking, and requires a cane to assist with ambulation.Severe pain and symptoms ultimately compelled plaintiff to undergo a risky, painful and costly revision surgery on (b)(6) 2014.These serious injuries prevent patient from practicing and enjoying the activities of daily life that she enjoyed pre-operatively.
|
| |
|
Manufacturer Narrative
|
|
(b)(4) (persisting back pain), (b)(4) (pseudoarthrosis), (b)(4) (leg pain).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) 2008 patient presented with following pre-operative diagnosis: intractable back and right leg secondary to herniated disk, l4-l5 with instability, questionable pars defect, l5-s1.Procedures: de-compressive laminectomy l4-l5 on the right with complete disc excision l4-l5, inter body graft l4-l5 using peek 11x11 graft with bmp, auto graft.Posterolateral fusion bilaterally l4-l5, l5-s1 with auto grafts.Bone graft, bmp, segmental pedicle screw fixation bilaterally l4-s1 with 6.5x40 mm screw with 2 peek rods with fluoroscopic guidance.Installation of preservative free duramorph intrathecal for post op pain control.Per op notes: ¿¿ auto graft was packed in to the interspace at l4-5 with dbm.After this was accomplished, surgeon then inserted the peek graft filled with rhbmp-2/acs and auto graft which was 11 high x 9 wide in to the interspace, countersunk it 5 mm.There was good purchase in to the end plates.The rest of autograft, rhbmp-2/acs, bone graft was placed in the posterolateral gutters on the right side for posterolateral fusion of the transverse processes, facet and interlaminar spaces were fused with rhbmp-2/acs, auto graft and bone graft¿¿ no known patient complications.On (b)(6) 2008 patient presented for office visit.Impressions: status post lumbar fusion l4 to s1 with improvement of radicular symptoms; continued back pain which is not unusual.The patient is very early in the healing process; narcotic dependency which is stable; urinary urgency due to prolapsed bladder.On (b)(6) 2008 patient presented for office visit.Impressions: status post posterior lumbar fusion l4 to s1 with resolving the mechanical back pain; intermittent leg pain, most likely secondary to peridural fibrosis; narcotic-dependency which the patient is beginning to wean off of her medication.On (b)(6) 2008 patient presented for office visit.Impressions: status post posterior lumbar fusion l4 to s1 with resolving the mechanical back pain; difficulty in the morning with muscle spasms which is not unusual.On (b)(6) 2008 patient presented for office visit.Impressions: status post posterior lumbar fusion l4 to s1 with resolving mechanical back pain; mild backache, most likely to continued deconditioning.On (b)(6) 2008 patient presented for office visit.Impressions: status post lumbar fusion l4 to s1 with exacerbation following traumatic assault which most likely is muscle in etiology.On (b)(6) 2008 patient presented for office visit.Impressions: status post lumbar fusion l4 to s1 with continued back pain with narcotic ¿ dependency, however the patient is willing to try and wean off her narcotics; work related contributing factor to back problems i.E.Working 12 hour shift with pushing, pulling and lifting.On (b)(6) 2008 patient underwent following examination: ct lumbar spine with multi planar reformatted imaging.Impressions: status post decompressive surgery in the lower spine with fusion present at l4-l5 and l5-s1.There is lucency surrounding the screws at the s1 level.This can be seen in loosening of the screws.One of the screws on left also extends to the inferior margin of the disk space where there is a small defect in the end plate.Do not see any canal or significant foraminal narrowing; bilateral renal stones.On (b)(6) 2014 patient presented with following pre operative diagnosis: failed lumbar fusion.Procedure: l4, l5, s1 removal of peek rods and 6 screws at l4, l5, and s1.Per op notes: ¿¿ 6 locking screws were removed and 2 peek rods.The screws were clearly loose at l4-l5 bilaterally and s1 bilaterally with toggling in their screw hole.Some 6 screws were then removed¿¿ patient also presented with following pre operative diagnosis: pseudoarthrosis and hardware malfunction.Procedures: exploration of fusion at l4, l5 and s1; re-do instrumented fusion of l4, l5, and s1; re-do arthrodesis of l4, l5 and s1; re-do allograft fusion of l4, l5 and s1; use of intraoperative monitoring.Per op notes: ¿¿ there was a pseudoarthrosis at l5-s1.There was lucency and loosening of the screws at s1 bilaterally and at l5 on the right.This was indicative of a pseudoarthrosis.Therefore it was decided to re-fuse.6.5 mm screws were removed.7.5x40 screws were placed at l4 and l5, and 8.5x45 screws at s1¿¿ no known patient complications were reported.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).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) 2010 patient presented for office visit with complaint of back pain and headache.On (b)(6) 2011: patient presented to office to follow up for repeat evaluation of urinary incontinence and uterovaginal prolapse.Patient's complaints include pain, dyspareunia, voiding dysfunction.On (b)(6) 2011: patient presented for office visit for urodynamics.On (b)(6) 2011: patient presented for office visit with uterovaginal prolapse and stress incontinence.Patient was fitted with pessary fitting for apical prolapse.On (b)(6) 2011: patient presented for office visit for evaluation of headaches.On (b)(6) 2012 patient presented for office visit.On (b)(6) 2012: patient presented for office visit with chief complaint of chronic lbp.On (b)(6) 2013, (b)(6) 2014: patient underwent bilateral digital screening mammogram with cad due to family history of breast cancer.Impression: stable mammographic appearance without evidence of malignancy.On (b)(6) 2013: patient presented for office visit with hand injury(left finger pain, left hand pain).Patient reports tingling in left hand.Patient underwent radiographic test of left finger.Impression: degenerative changes second dip joint with an equivocal impaction and /or articular fracture at the base of the distal phalanx.In addition there is surrounding soft tissue swelling.On (b)(6) 2013: patient presented with complaint of vomiting, diarrhea, migraine.On (b)(6) 2013: patient presented with soft tissue injury to left foot.On (b)(6) 2014, (b)(6) 2015: patient presented for med check and to talk about adipex.Assessment: low back pain; weight gain.On (b)(6) 2014: patient underwent x-ray of lumbar spine.Impression: l4 through s1 lumbar fusion with minimal lucency surrounding the pedicle screws at s1, which can be indicative of hardware loosening.On (b)(6) 2014: patient presented for follow up on left finger pain.Assessment: degenerative arthritis of finger; family history of malignant hyperthermia.On (b)(6) 2014: patient presented with complaint of low back pain.On (b)(6) 2014: patient underwent x-ray of lumbar spine.Impression: postoperative changes of posterior fusion at l4 through s1, stable; moderate degenerative change at l4-l5 and mild at l5-s1, stable; no evidence of instability; previously described periprosthetic lucency involving the pedicle screws at s1 is faintly visualized.Patient also underwent ct of lumbar spine without contrast.Impression: since (b)(6) 2008, interval l4-l5 laminectomies and l4-s1 bilateral posterior pedicle screw fusion.There were lucent rims surrounding the bilateral s1 pedicle screws, suggestive of hardware loosening; t11-t12: a broad-based disc- osteophyte mild to moderate right and mild left foraminal stenosis; mild degenerative changes at the l3-l4 through l5-s1 levels, resulting in l5-s1 mild left foraminal narrowing, l4-l5 minimal right foraminal narrowing and l3-l4 minimal bilateral foraminal narrowing.Patient also underwent bilateral mammogram screening.Impression: stable mammograms without evidence of malignancy in either breast.On (b)(6) 2014: patient underwent "xr lumbar spine minimum 4 views".Impression: "postoperative changes of posterior fusion at l4 through s1, stable; moderate degenerative change at l4-l5 and mild at l5-s1, stable; no evidence of instability; previously described per prosthetic lucency involving the pedicle screws at s1 are faintly visualized." on (b)(6) 2014 patient presented for office visit.On (b)(6) 2014 patient presented for office visit.Her mri further documents loosening of her screws at s1.Patient is in a great deal of pain.On (b)(6) 2014 patient underwent "mr lumbar spine with and without contrast".Impressions: "status post l4 through s1 posterior fixation with posterior decompression at l4-l5.There is no evidence of spinal canal stenosis or significant neural foraminal narrowing; bilateral screw loosening at s1 with non-fusion at the l5-s1 level is better demonstrated on prior ct scan." on (b)(6) 2014: patient presented for office visit for hand pain.Diagnosis: degenerative arthritis of finger.Patient underwent x-ray of finger.Impression: interval fusion at the second dip joint with intact hardware.Diffuse soft tissue swelling.On (b)(6) 2014: patient presented with complaint of acute and chronic pain.On (b)(6) 2014: patient presented with pre-op diagnosis of: left index finger pain; left index finger osteoarthritis.For which patient underwent left index finger distal interphalangeal joint arthrodesis.Patient tolerated the procedure well without any intraoperative complications.On (b)(6) 2014: patient presented for med check for pain meds.Assessment: low back pain, abnormal weight gain.On (b)(6) 2014: patient underwent colonoscopy.Impression: preparation of the colon was poor; stool in the entire examined colon; non-bleeding internal hemorrhoids.On (b)(6) 2014: patient presented for history and physical examination for scheduled removal of l4-s1 instrumentation.Patient was noted to have recent hematuria on urinalysis.Assessment: failure of hardware; chronic low back pain; migraine headaches; chronic opioid use; recent hematuria on urinalysis; elevated bmi; lee revised cardiac risk index equals 0.On (b)(6) 2014 patient presented for office visit with complaint of chronic pain.Patient underwent "xr lumbar spine limited study".Impression: post surgical changes consistent with posterior fusion at l4 through s1 with laminectomy and interbody fusion at l4-l5; prominent lucency around the s1 screws is again noted suspicious for loosening; no acute fracture or subluxation (b)(6) 2014 patient presented for office visit.On (b)(6) 2014 patient presented underwent "xr lumbar spine 2 or 3 views".Impression: "l4-s1 fusion described.Hardware appears intact and alignment appears unchanged.Well defined lucency compatible with bony resorption surrounding the l5 pedicle screws is stable or slightly increasing since the comparison study." on (b)(6) 2014 patient presented for office visit.On (b)(6) 2014 patient presented for office visit.Assessment: low back pain.On (b)(6) 2014 patient presented for office visit.On (b)(6) 2015: patient presented for med check for methadone.Assessment: low back pain.On (b)(6) 2015: patient presented with chief complaint of pelvic organ prolapse.Patient describes both palpable and visible prolapse to beyond the vaginal introitus with associated feelings of pelvic pressure.Patient reports some joint pain and muscle weakness in the lower back and lower extremities.Patient also reports ongoing issues with migraines.Impression: patient complete uterovaginal vault prolapse.She also has stress urinary incontinence by history, as well as urinary urgency, frequency and nocturia.She also reports feelings of incomplete bladder emptying and longstanding issues with constipation.On (b)(6) 2015: patient presented with chief complaint of uterovaginal vault prolapse, stress urinary incontinence and feelings of incomplete bladder emptying.Patient underwent urodynamic testing.Impression: no evidence of urinary incontinence, intrinsic sphincter deficiency or detrusor instability.Patient underwent (b)(6) test.Cytopathology report is negative for intraepithelial lesion and malignancy.On (b)(6) 2015: patient presented for treatment discussion for her prolapse and incontinence.Patient's chief complaints are complete uterovaginal vault prolapse and stress urinary incontinence.Patient reports occasional night sweats as well as difficulty swallowing, workup of latter has been negative.Patient also has had issues with constipation related to irritable bowel syndrome.She also reports some muscle weakness in the lower back and lower extremities as well as issues with migraines.Impression: there is no evidence of stress urinary incontinence, intrinsic sphincter deficiency or detrusor activity/instability on urodynamic testing.On (b)(6) 2015: patient presented with pre operative diagnosis of complete uterovaginal vault prolapse, retroperitoneal fibrosis and underwent supracervical abdominal hysterectomy, bilateral salpingo-oophorectomy , abdominal sacrocolpopexy, vaginal repair of enterocele, posterior colporrhaphy, perinerorrhaphy and cystoscopy.There were no patient complications.On (b)(6) 2015: patient presented for office visit.On (b)(6) 2015: patient presented for post operative follow up visit.On (b)(6) 2015: spinal range of motion is limited due to chronic pain.On (b)(6) 2015: patient presented for post op visit with complains of cramping, yellowing brown discharge, recent bloody bowel movement, bright red blood.Diagnosis: lower urinary tract infection.On (b)(6) 2015: patient presented for post operative evaluation.On (b)(6) 2015: patient presented for her early annual wellness visit.Assessment: general medical exam; low back pain; migraine; abnormal weight gain, therapeutic drug monitoring.On (b)(6) 2015: patient presented for medication check up.Assessment: low back pain.On (b)(6) 2016: patient presented for med check and initiate adipex treatment.Assessment: weight gain, drug therapy, low back pain.On (b)(6) 2016: patient presented for follow up on adipex.Assessment: weight gain, drug therapy.
|
| |
|
Search Alerts/Recalls
|
|
|
