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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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| Catalog Number 7510800 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Chest Pain (1776); Dysphagia/ Odynophagia (1815); Bone Fracture(s) (1870); Headache (1880); Neuropathy (1983); Pain (1994); Scarring (2061); Swelling (2091); Stenosis (2263); Injury (2348); Neck Pain (2433); Burn, Thermal (2530); Osteopenia/ Osteoporosis (2651)
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Event Type
Injury
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Manufacturer Narrative
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(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.
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Event Description
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It was reported that on (b)(6) 2009: patient presented with pre-op diagnosis: pseudoarthrosis with loosened pedicle screws at l4.Procedure: hardware removal and exploration of fusion at l4-5.Re- instrumentation of l4-5 with large diameter pedicle screws at l5 and hydroxyapatite- coated screws at l4 as well as rods.Use of right morselized iliac crest bone autograft as well as rhbmp-2/acs bone morphogenic protein product in the lateral gutters at l4-5.Per-op notes: hardware were identified and set screws, rods and pedicle screws were removed.The screws at l4 were loose.A hydroxyapatite coated pedicle screws were used.Then 6.5mm screws at l5 were replaced with larger diameter 7.5mm screws, same length.At l4 cement was injected into the pedicle screws hole.An intraoperative x-ray confirmed hardware in good position.A fair amount of morselized iliac cres bone autograft into the lateral gutters over the decorticated bony element as well as bone morphogenic protein product.No complications were reported.Patient underwent x-ray of the lumbar spine.Impression: interval exchange of pedicle screws, posterior fixation rods l4-5.Mild subluxation l4 on l5 of approximately 7mm.On (b)(6) 2010: patient underwent ct myelogram.Impression: no soft tissue abnormality of the abdomen or pelvis to explain the patient's pain.Increasing anterior spondylolisthesis of l4 on l5 despite surgical intervention.On (b)(6) 2011: patient presented with left side pain, trouble swallowing.On (b)(6) 2011: patient presented for follow up.Impression: severe eye pain, acute glaucoma, facial drooping with eye and temple pain, question etiology.Certainly need to consider a temporal arteritis.On (b)(6) 2012: patient presented with heat burn, chest pain, right ear pain, pressure headaches, feel worse at right, gerd (b)(6) 2012: patient presented with bilateral shoulder pain.On (b)(6) 2012: patient presented with neuropathy pain, bilateral shoulder pain.On (b)(6) 2013: patient presented with hand pain and finger swelling.On (b)(6) 2013: patient presented with hand pain and swelling.Patient underwent x-ray of the left hand.Impression: old fracture of fifth metacarpal.Osteoarthritis at the fifth pip joint.Patient underwent x-ray of the right hand.Impression: erosions the ulnar styloid, proximal aspect of the fifth metacarpal and distal scaphoid bone, marginal erosions of the second and third metacarpal heads.On (b)(6) 2013: patient presented with hand pain and swelling, leg pain, chronic left flank pain.On (b)(6) 2013: patient presented with scar neuroma formation with neuropathic pain.Bilateral lower extremity peripheral neuropathy with a likely small fiber neuropathy.Chronic degenerative joint disease in the shoulders.Lumbar degenerative disc disease.On (b)(6) 2013: patient presented for follow up.Assessment: peripheral neuropathy, diabetic foot pain with small fiber neuropathy.On (b)(6) 2013: patient met an accident.On (b)(6) 2013 and (b)(6) 2014: patient presented for follow-up of right shoulder pain and back pain.Patient presented with the following diagnosis: complaint of dm, diabetic neuropathy, chronic left flank pain, chronic low back pain, palpations.On (b)(6) 2013: patient presented with low back pain, chronic left flank pain.Patient presently complaints of persistent pain in lower, numbness in both legs and both hands, shoulder discomfort, hip pain, constant tingling and burning in both feet, sexual dysfunction, depression/mental anguish.Patient was unable to sit/ stand for long periods of time.
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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) 2009: patient underwent right shoulder 4 views.Impression: normal right shoulder.On (b)(6) 2009: patient presented with following preop diagnosis: full thickness rotator cuff tear right shoulder with subacromial impingement.Procedure: open arthroscopy with minor debridement labral tissue.Open rotator cuff repair, acute, subacromial decompression acromioplasty with bursectomy and coracoacromial ligament release.On (b)(6) 2009: patient presented with right shoulder pain.On (b)(6) 2010 patient presented with left flank and left sided abdominal pain.Patient presented for er xr abdominal series.Impression : no acute cardiopulmonary or abdominal findings.On (b)(6) 2010 patient presented for er xr hand right: conclusion: acute fracture proximal phalanx.Suspect old, fracture mid phalanx, but with deformity and arthritic changes proximal interphalangeal-joint.On (b)(6) 2010 patient presented with hand injury.On (b)(6) 2010 patient presented for ct renal stone (noncontrast abdomen and pelvis ct).Impression: no acute obstructive uropathy.Small gallstone.Grade ii anterolisthesis l4 on l5 with possible loosening around the l4 pedicle screws.On (b)(6) 2011: patient got admitted in the facility for some tests.On (b)(6) 2011: patient presented with left side pain, trouble swallowing.On (b)(6) 2012: patient presented with anterior shoulder at bicipital groove area and also in lateral upper arms.Stabbing aching pain.On (b)(6) 2015 patient for presented for "er xr chest pa and lat".Impression: unremarkable chest.On (b)(6) 2015 patient for presented for "er xr lumbosacral spine ap and lat." impression: no acute findings.Intact posterior fixation hardware.Grade 2 anterolisthesis l4 on l5.On (b)(6) 2015 the patient was diagnosed for lumbago, pain in soft tissue of limb.On (b)(6) 2015 the patient was diagnosed for pain in joint, shoulder region.
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Event Description
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It was reported that on (b)(6) 2009: the patient also underwent fluoroscopic guided lumbar myelogram.Impression: grade i/ii anterolisthesis l4 on l5.Moderate central narrowing, l3-4.Findings compatible with nerve root impingement, l4-5 and l5-s1 on the left.On (b)(6) 2009: the patient presented with lower back pain.Assessment: lower back pain with lower extremity radiculopathy.History of previous lumbar fusion with pseudoarthrosis at l4-5.Rade 4 spondylolisthesis of l4-5.On (b)(6) 2009: the patient was discharged home in stable condition.
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Manufacturer Narrative
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Add'l info: (b)(4).
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Event Description
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It was reported that on (b)(6) 2013, the patient presented for follow up of posterior tibial nerve block.Assessment : diabetic peripheral neuropathy and bilateral foot pain.(b)(6) 2013, the patient presented for follow up regarding evaluation and treatment of the neuropathic pain.(b)(6) 2013, the patient presented with pre-op diagnosis of small fiber neuropathy and extremity pain and underwent treatment of small fiber neuropathy (b)(6) 2015 the patient was presented for office visit with low back pain, bilateral lower extremity pain.(b)(6) 2015 the patient was presented for office visit with neck and shoulder pain.The patient also underwent x rays of the cervical spine and shoulders.There was some ac and glenohumeral arthritis in the left shoulder.In the right shoulder again there was a little bit of glenohumeral degeneration and ac arthritis.The lateral cervical spine shows decreased lordosis with age appropriate degenerative change but no significant malalignment.(b)(6) 2015 the patient was presented for office visit with low back pain and lower extremity pain anterior into his feet.Assessments: low back pain with bilateral anterior lower extremity pain that radiates into both feet, worsened with a head on collision on (b)(6) 2015 and then when he fell into a hole at a car wash later in (b)(6) 2015: the patient presented for a follow up.(b)(6) 2015 the patient was presented for office visit with left shoulder pain and right shoulder pain.(b)(6) 2015 the patient was presented for office visit with low back pain.Mri studies were reviewed.They do show the hardware previously placed at l4-5.They are still well positioned.He still has spondylolisthesis at this level, but there seems to be fusion here.(b)(6) 2015 the patient was presented for office visit with bilateral shoulder pain.
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Manufacturer Narrative
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Add'l info: (b)(4).
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Event Description
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It was reported that on (b)(6) 2011 patient admitted to hospital in emergency department for the diagnosis of chronic abdominal pain, left lower quadrant.(b)(6) 2011 patient underwent the following exam: right upper quadrant ultrasound.Impression: cholelithiasis with no abnormal gallbladder wall thickening or biliary ductal dilatation.The pancreas was obscured by gas.(b)(6) 2011 patient presented due to abdominal bloating and cholelithiasis.Impression: no scintigraphic evidence of acute cholecyst itis or biliary obstruction.(b)(6) 2012 patient presented due to nose abscess.(b)(6) 2012 patient underwent ct maxillofacial area w/o contrast.Impression: 1.No significant paranasal sinus disease was appreciated.The ostiomeatal units appear patent bilaterally.2.There was slight bowing of the nasal septum rightward.(b)(6) 2012 patient underwent pa chest with three views of the left ribs impression: mildly displaced left anterior 9th rib fracture.(b)(6) 2012 patient underwent three-view study of the right hand and three-view study of the right wrist.Impression: slightly atypical findings of the distal radius which may be chronic though a non-displaced, minimal buckling type injury of the metaphyseal region cannot be entirely excluded.(b)(6) 2013: patient underwent posterior tibial nerve block to treat the pre-op diagnosis of peripheral neuropathy, bilateral foot pain.(b)(6) 2013 patient underwent dx spine lumbar 2 or 3 views.Impression: 1.Foreign body material overlying or within the distal right sacrum.2.Postsurgical changes as described.Grade ii l4 anterolisthesis noted with evidence of pedicle screw loosening at l4.The stability of the l4 vertebral body is unclear given the presence of extensive bone fusion on either side of the l4-l5 disc space however.Without the benefit of comparisons studies it's not possible to determine whether l4 is stable and pedicle screw loosening of recent origin.(b)(6) 2014 patient underwent dx foot minimum 3 views.Impression: acute fracture of the proximal -mid diaphysis of the left fourth proximal phalanx.Old fracture of the left fifth metatarsal.(b)(6) 2015 patient presented due to back pain, toe pain-swelling, extremity injury- minor.Impression: diagnosis: lumbar strain and closed fracture of the toe.(b)(6) 2015 patient underwent lumbosacral spine.Three views.Impression: stable mild grade 2 anterior spondylolisthesis of l4 on l5.Postoperative changes are also noted at the lower lumbar levels as discussed above.Otherwise no evidence of acute fracture, dislocation or bony destructive process.(b)(6) 2015 patient underwent dx chest pa and lat.Impression: mild prominence of increased pulmonary markings at the left lung base consistent with minimal interstitial pneumonitis.(b)(6) 2016: patient had a mvc on (b)(6) 2015 and present with chief complaint of rib and back pain.Patient underwent x-ray examination of foot.Impression: 1) comminuted and mildly impacted fracture of the 4th proximal phalanx.2) mild osteopenia.On physical examination mild vertebral point tenderness over the lumbar spine and tenderness and mild swelling of the left fourth toe.Clinical impression: left 4th metatarsal fracture, chest wall strain and back strain.Patient underwent x-ray of lumbosacral spine (ap and lateral).Impression: 1) no acute findings.2) intact posterior fixation hardware.3) grade 2 anterolisthesis l4 on l5.
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