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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 7510400 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Arthritis (1723); Fatigue (1849); Fever (1858); Bone Fracture(s) (1870); Unspecified Infection (1930); Inflammation (1932); Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Swelling (2091); Stenosis (2263); Depression (2361); Numbness (2415); Sleep Dysfunction (2517); No Code Available (3191)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a transforaminal lumbar interbody fusion from l3 to l5, during which rhbmp-2/acs was used.Sometime postop, the patient reportedly began to experience intractable lower back pain that radiates into the lower extremities.The patient also had a persistent and severe inflammatory reaction that led to a failure of his spinal hardware.It is reported that most recently the patient has urinary dysfunction and lower extremity numbness.
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Manufacturer Narrative
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(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.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on, (b)(6) 2011: the patient underwent mri of lumbar spine due to lumbar herniated nucleus pulposus with history of compression fracture.Impression: compression deformity of the anterior superior end plate of the l4 vertebral body likely chronic in nature with no evidence of retropulsion; bilateral neural foraminal stenosis as a consequence of diffuse bulge of the annulus fibrosis l3-l4 and l4-l5.On (b)(6) 2011: the patient underwent epidural steroid injection.On (b)(6) 2011: the patient underwent ct guided epidural steroid injection due to low back pain.No patient complications were reported.On (b)(6) 2011: sleep disturbance.On (b)(6) 2011: the patient called and complained of orgasmic dysfunction induced by citalopram.On (b)(6) 2012: the patient presented with the following pre-operative diagnosis: l3-4 and l4-5 lumbar spinal stenosis with radiculopathy and spondylosis at 2 levels.He underwent the following procedures: l3, l4 and l5 laminectomy; transverse lateral interbody fusion using instrumentation and rh-bmp2/acs at l3-l4 and l4-5 levels; intraoperative fluoroscopy and interpretation.Per op notes, trial spacers were placed at both levels and it was observed that 9mm trail spacers were the perfect fit for both the levels.Therefore, they were fused 9mm, straight, stryker peek implant filled with rh-bmp2/acs sponges for both levels.The interbody implants were tapped into the l3-4 and l4-5 spacers under fluoroscopic guidance in the usual manner.The final position of the implant was checked using lateral fluoroscopy and was found satisfactory.No patient complications were reported.He also underwent x-ray of portable lumbosacral spine, intra-op, which showed bilateral pedicle screws from l3 through l5, with paraspinal rod on the left; anterior spinal fusion from l3 through l5 noted with disckectomy and interbody graft interposition; l3 through l5 laminectomies were also observed.A ct of lumbar spine was done to evaluate fusion.Impression: l3-5 laminectomies and posterior spinal fusion along with l3-4 and l4-5 diskectomies with interbody graft placement, without evidence of significant complications.On (b)(6) 2012: the patient was discharged home in good condition.On (b)(6) 2012: the patient presented for wound check.There were some concern with redness and swelling.Assessment: mild wound drainage.On (b)(6) 2012: the patient presented for wound evaluation.He reported bleeding from the superior margin of the wound.Impression: likely superficial hematoma.On (b)(6) 2012: the patient presented for follow-up with discogenic back pain.On (b)(6) 2012: patient presented for follow-up.Assessment: anxiety and depression.On (b)(6) 2013: the patient presented for recheck.Assessments: sleep apnea.On (b)(6) 2013: the patient presented for an office visit with increased low back pain.Diagnosis: discogenic back pain status post two-level tlif, back pain worse than preoperative baseline.On (b)(6) 2014: the patient presented with low back pain.Assessment: post laminectomy syndrome, lumbar stenosis.
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Manufacturer Narrative
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Additional info : image review (b)(6) 2011 lumbar mri sagittal views show disc space degeneration and narrowing at l3 and l4 with posterior bulging discs at these levels.Discs above and below appear normal.No foraminal stenosis is appreciated.Anterior endplate collapse is seen in the superior endplate of l2 with sclerosis and fragmentation of the upper half of the body at this level.There is also increase signal within the interspinous space between l3 and l4 suggesting some instability at this level.L3/4 facet joints appear normal on t2 images.On (b)(6) 2011 abdominal ct adds no additional information to assessment of lumbar pathology.Abdominal contents appear grossly normal.On (b)(6) 2012 pa lumbar x-ray single ap view shows screws in place at l3, l4 and l5.Peek interbody spacers are in place at l3 and l4.Full decompressive laminectomies have been performed from l2 to l5.On (b)(6) 2012 lumbar ct pedicle screws are seen bilaterally at l3, l4 and l5.L3 screw penetrates the lateral vertebral wall on the right.Posterolateral fusion bone is seen about the construct but is not fused.No heterotopic bone is seen.Spacers appear to be crescent.They are well positioned, but fusion has not yet occurred.No other pathology is noted at other levels.Sagittal reconstructions also show lack of fusion.No additional information is provided.On (b)(6) 2013 lumbar ct spot view shows pedicle screw fusion construct from l3-l4-l5 with screws, rods and interbody spacers.Axial images show crescent spacers at l3 and l4 with screws and rods in good position.Full decompression has been performed posteriorly in the region of the fusion.No evidence of heterotopic bone is noted in any cuts.Sagittal and coronal cuts are reviewed for fusion solidity.There are very tenuous bridging areas, but these are far too small to stabilize the levels involved.General lordosis is flattened.Other levels appear normal.Coronal levels verify excellent position of screws.No residual stenosis is noted in the central canal or foramen at any level.
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Manufacturer Narrative
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Phone number :(b)(6).(b)(4).
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Event Description
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It was reported that on (b)(6) 2010: the patient presented for an office visit due to right wrist injury.(b)(6) 2010, patient presented for microbiology tests.(b)(6) 2011: patient underwent xray of lumbar spine due to lumbago.Patient also complained of chronic pain since 6 years.(b)(6) 2011: the patient underwent x-rays of the lumbar spine due to lower back pain.Impression: minimal scoliosis and almost completely straightened lumbar lordosis, versus splinting; an old anterosuperior fracture of l4, and also apparently l5.The l3-4 and l4-5 disc spaces are minimally narrow.(b)(6) 2011: the patient underwent surgical removal of wisdom teeth.(b)(6) 2011: the patient presented with low back pain.The patient had a history of hyperextension injury due to falling out of military bus (2006).Two years previous to the day of visit, the patient suffered a flare of pain that caused severe muscle spasm and lasted several days.He normally had stiffness and mild to moderate pain localized to the low lumbar region.He had an xray of lumbar spine that revealed l4 and l5 vertebral fractures that appeared chronic.Musculoskeletal exam revealed mild tenderness to palpation at lower lumbar paraspinals, loss of lumbar lordosis, and mild reduction in thoracolumbar flexion.Diagnosis: 1.L4 and l5 lumbar vertebral fracture - chronic 2.Suspected lumbar ddd 3.Lumbar spondylosis (b)(6) 2011: the patient presented with low back pain.His mri was reviewed which demonstrated l3/4 and l4/5 ddd and a chronic l4 endplate fracture.Diagnosis: l4 vertebral fracture - chronic 2.Lumbar ddd l3/4, l4/5 3.Lumbar spondylosis (b)(6) 2011: the patient presented with increasing low back pain over the past two months.(b)(6) 2011: the patient presented with low back pain and reported excellent result from his esi thus far.(b)(6) 2012: the patient underwent multiple portable x-rays of lumbosacral spine (b)(6) 2012: the patient underwent ct scan of lumbar spine without contrast.Impression: l3-5 laminectomies and posterior spinal fusion along with l3-4 and l4-5 diskectomies with interbody graft placement, without evidence of significant complication.(b)(6) 2013: the patient described his pain as aching, sharp, throbbing, exhausting, miserable and continuous.The pain was reported to be worst in the afternoon and evening.The pain would worsen by strenuous activities.(b)(6) 2013: the patient described his pain as aching, sharp, penetrating, throbbing, stabbing, exhausting, miserable and tiring.The pain was reported to be worst in the evening.The pain would worsen on overdoing activities, carrying child.(b)(6) 2013: the patient underwent xr of lumbosacral spine 2 or 3 views.Impression: stable post surgical changes of fusion.(b)(6) 2013: the patient underwent psychodiagnostic evaluation.Conclusions: axis i: ptsd, dysthymic disorder, generalized anxiety dis order, history of alcohol abuse.Axis ii: diagnoses deferred.Axis iii: history of back injury.Axis iv: psychosocial stressors: posttraumatic stress, chronic pain, new child in the family.Axis v: current gaf: 50; highest gaf past year: estimated 50 (b)(6) 2013:.Musculoskeletal examination revealed chronic low back pain and apparent spinal fracture, arthritis in other joints, osteoporosis.Psychological exam was positive for mood swings, depression, anxiety.(b)(6) 2014: the patient underwent lab tests for blood.
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Manufacturer Narrative
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(b)(4).
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Event Description
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(b)(6) 2011: the patient presented to establish care.Patient had multiple problems; chronic pain; depression; orgasmic dysfunction secondary to his medications; anxiety; osteoarthritis; history of back fracture; degenerative disc disease with a strong family history of degenerative disc disease; fungal nail infection; color deficient vision.(b)(6) 2015: the patient presented with back pain and wound drainage with low grade fever.Assessment: mild wound drainage, probably from some seroma after his very extensive back surgery; some low grade fever during this, treated with keflex but no clinical evidence of a wound infection.(b)(6) 2012: the patient presented for wound check.There were some concern with redness and swelling.(b)(6) 2012: the patient presented for follow-up and he was having issues with his pain control.Assessment: wound inflammation, most likely reaction to dissolvable sutures which were removed as much as feasible, can not rule out a low grade cellulitis but no fluctuance or other suspicious symptoms with ongoing post-operative muscle spasms and pain after very extensive back surgery.(b)(6) 2012: the patient presented for follow-up.Assessment: post-operative pain with his chronic back pain significant improved; orgasmic dysfunction, depression and anxiety doing well.(b)(6) 2012: the patient presented for follow-up.Assessment: overall doing better after his back surgery with dramatic decrease in his post-operative medication use.Depression is doing well; orgasmic sexual dysfunction, significantly improved with periactin; anxiety, stable.(b)(6) 2012: the patient presented with history of previous l3-l5 laminectomies with rod fixation and underwent ct of lumbar spine and comparison was made with (b)(6) 2012.Impression: progression of disc based irregularity at the l3-4 and l4-5 discs.Differential considerations include changes related to slowly incorporating bone plugs, incomplete bony union/motion, or infection.If there is clinical concern for infection, suggested mri with contrast.(b)(6) 2012: results of ct scan done on (b)(6) 2012 was reviewed.There is a fracture of the l3 transpedicular screws bilaterally at their bracket.There is a questionable fracture of the l4 bilateral screws at their bracket.The l5 screws appear intact.The fusion remains incomplete posteriorly.There is slightly more irregularity in the l3-4 and l4-5 disc plug.There is limbus change at the l4 superior end plate anteriorly and more focal osteoarthritic spondylosis at l3-4 and l4-5.Assessment: significant problems after the fusion surgery; ongoing pain with multiple broken screws.(b)(6) 2012: the patient underwent ct scan of lumbosacral spine without contrast.Impression no evidence of screw fractures.(b)(6) 2012: the patient presented for recheck and he pain continued to be problematic.It was not really changed much.It had been adequately controlled.Assessment: chronic pain with advanced back disease after extensive back surgery.Healing adequately with no evidence of hardware failure.(b)(6) 2012: the patient presented for recheck and was doing well.Depression and orgasmic dysfunction are doing well on his current m edications.He has not had any falls, injuries, or other exacerbating factors.(b)(6) 2012: the patient presented doing fairly well other than some increased fatigue.Assessment: chronic pain; arthritis; degenerative disc disease; depression.(b)(6) 2012: the presented with significant stress issues.His back and chronic pain were well controlled.Assessment: significant stress issues; underlying back pain; degenerative disc disease; disability.(b)(6) 2012: the patient presented for follow-up and doing significantly better.Anxiety, depression were much improved.Assessment: anxiety; depression; chronic pain; arthritis; degenerative disc disease.(b)(6) 2012: the patient presented for follow-up.Depression, anxiety and sleep disturbance all were improving.Assessment: overall stable.(b)(6) 2012: patient presented for follow-up and was not doing well.He has not had any aberrant behavior.His depression is fairly stable.Assessment: hypoxemia, sleep apnea, chronic pain, arthritis.(b)(6) 2012: the patient presented for follow-up and was doing well.(b)(6) 2012: patient presented for follow-up and was doing well.Patient had some increase in his back problems to taking long trips no other injuries or exacerbating factors.Assessment: chronic back pain.(b)(6) 2013: the patient had sleep study and that does not show any significant sleep apnea.Still he was having significant sleep problems, ptsd, symptoms and anxiety.Pain control was adequate.There was not ant aberrant behavior.Assessment: chronic pain; degenerative disc disease; sleep disturbance, depression; some degree of ptsd.(b)(6) 2013: the patient presented for follow-up.Assessment: chronic pain; anxiety and depression; maintaining function but not making improvement with desire to taper off his narcotis in the near future.(b)(6) 2013: the patient presented for follow-up and was doing well, assessment: chronic back pain, fairly stable; degenerative disc disease, status post extensor surgery; arthritis; high stress; obesity.(b)(6) 2013: the patient presented for follow-up and was doing well with his chronic pain.Assessments: high stress, chronic back pain.(b)(6) 2013: the patient presented for recheck.Assessments: anxiety/ depression, arthritis, degenerative disc disease, status post fusion, advanced fungal nail infection.(b)(6) 2013: the patient underwent ct scan of the lumbar spine due to status post back fusion with low back pain paresthesias.Comparison is made with the previous mri of the lumbar spine dated (b)(6) 2011.Impression: status post 13 through ls anterior and posterior lumbar fusion with anatomic alignment and l3, l4 and partial l5 laminectomies; straightening of the normal lumbar lordosis; mild bilateral facet arthropathy, 15-s1.(b)(6) 2013: the patient was called about his ct scan of the lumbar spine, which did not show increased calcific density bridging the l3-l4, l4-l5 interspaces.The hardware was intact and appeared stable.(b)(6) 2013: the patient presented with chronic back pain, degenerative disc disease status post fusion without evidence of fusion on his ct scan, arthritis, hyperlipidemia with low hdl, fungal nail infection, hands and feet, improving on lamisil.Ct scan showed no evidence of fusion but hardware being intact.(b)(6) 2013: the patient presented with problems of chronic pain after failed fusion of his back with an experimental product; degenerative disc disease; arthritis; depression; anxiety; fungal nail infection.Assessment: chronic back pain; failed back fusion which was extensive with experimental product which seems to be increasing his back pain rather than improving; anxiety; depression; sexual dysfunction; fungal nail infection, improving on his lamisil.(b)(6) 2013: the patient presented with problems of chronic pain, degenerative disc disease, arthritis, urinary hesitancy.Assessments: chronic back pain, urinary symptoms.(b)(6) 2013: the patient presented for follow-up and complained about chronic back pain after the surgery.He was taking a maximum of 30 mg of oxycodone a day.Past medical history were depressions, chronic low back pain, sleep disturbance, hypertriglyceridemia.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on (b)(6) 2006, the patient presented with complaint of swelling.On (b)(6) 2007, the patient presented with complaint of dizziness, light headed.On (b)(6) 2009, the patient presented with complaint of reduced hearing in left ear.On (b)(6) 2013, the patient was admitted and underwent pathological evaluations - chemistry, hematology.On (b)(6) 2013, the patient presented with lower back pain.The patient described the pain as aching.Also had tingling and burning sensation.On (b)(6) 2015, the patient presented for follow up and complaint of depression, low back pain.
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