MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Catalog Number 7510800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Palpitations (2467); Weight Changes (2607)

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) 2012 patient underwent mri lumbar spine.Impression: 1.Chronic l45 and l5-s1 degenerative disk changes with grade 1-2 lytic spondylolisthesis (l5-s1).On (b)(6) 2012 patient presented with back pain, bilateral leg pain and numbness.Msk exam: there are no trigger points noted in the spinal or para spinal region.The patient has (b)(6) slr's bilaterally.Rom of hips and shoulders are painless.Facet loading maneuvers are non-provocative.On (b)(6) 2012 patient underwent the endoscopy procedure.Assessment: mild appearing gastritis and duodenitis without evidence of ulcer or erosion.On (b)(6) 2012 patient presented with acquired spondylolisthesis, abdominal pain, epigastric, epigastric pain, palpitations, abdominal pain, reflux, esophageal, abnormal mammogram dx benign, abnormal mammogram, disc disease, lumbar l4-5 r effacement, other specified disease of nail, elevated blood pressure, anxiety state, hypercholesterolemia, insomnia, dysmenorrhea, premenstrual dysphoric syndrome, chromopertubation, lymphedema, grief reaction, fatigue, hypothyroidism.On (b)(6) 2012 patient admitted with following diagnosis: symptomatic l4-5 and l5-s1 degenerative lumbar spondylosis with grade 1/2 degenerative l5-s1 spondylolisthesis.Stage 1: anterior retroperitoneal approach for an l4-5 diskectomy, partial l5 vertebrectomy.Anterior inter body arthrodesis, l4-5, l5-s1.Application of peek.Interbody spacers, l4-5, l5-s1.Application of anterior lumbosacral plate with buttress screw, l5-s1.Harvest of autologous iliac crest graft, cancellous, right iliac crest, for use in interbody arthrodesis at l5-s1.Use of intraoperative fluoroscopy.Stage ii: percutaneous pedicle screw fixation l4-s1 utilizing the amendia percutaneous pedicle screw fixation system.Use of intraoperative fluoroscopy.Post operatively she was slowly mobilized.Other implants used independence spacer.5.5 x 25 bone screw, 4.5 x 40 mis pedicle screw, 4.5 x 55 mis pedicle screw, 4.5 x 45 mis pedicle screw, 40mm mis rod.Per-op notes: the spacer was packed with the combination of auto graft obtained from the iliac crest, as well as half of a large dose of rhbmp-2.This combination of bone graft material was placed in the interbody and then recessed into the interbody defect without difficulty.The anterior plate was applied to the peek spacer and a single buttress screw was utilized and placed through the plate into the s1 vertebra.This screw was a 5.5 x 25 mm long screw.An 11 blade was utilized to make an annulotomy in a very degenerative, collapsed l4-5 disk.Then utilized a combination, once again, of rotating curettes, as well as chisels to release the interbody space circumferentially back to the posterior longitudinal ligament utilizing lateral fluoroscopic guidance.The endplates were prepared with the bone rasp.At this point, doctor chosen to place a single alif peek spacer into the defect.The spacer measured 11 mm tall and was 30 mm wide.This was placed obliquely into the disk space in order to prevent much retraction on the great vessels, but ultimately was positioned in the midline by utilizing lateral and a-p fluoroscopic imaging.The implant had been previously packed again with a combination of infuse and auto graft.Of note, the complication had at: the l4-5 interspace was noting some bleeding coming from perhaps a small branch of the inferior vena cava.This was controlled with nu knit as per dr.Mangalat's recommendation.No further bleeding occurred once all release of retraction was performed.However, it did end up losing about 800 ml of blood from this area intermittently throughout: the case, particularly when they were working at the l4-5 interspace.The patient:, otherwise remained hemodynamically stable throughout the operation.Patient underwent x-ray.Impression: no evidence of retained instrument.On (b)(6) 2012 patient discharged.On (b)(6) 2012, (b)(6) 2012 patient admit in emergency room for complaint of leg pain.On (b)(6) 2012 patient presented for complaints of leg pain.On (b)(6) 2012 patient presented with chief complaint bilateral thigh pain, anteriorly and posteriorly.Patient diagnostic with ct scan of the abdomen and pelvis.Impression: postoperative leg pain, likely related to nerve irritation.Status post anterior and posterior l4-l5, l5-s1 fusion for a grade 2 spondylolisthesis with degenerative disk disease at l4-l5.Polypharmacy.History of attention deficit disorder.Patient underwent ct scan of abdomen.Impression: no acute upper abdominal pathology.Nonvisualized left kidney.Surgical versus congenital absence.Patient underwent ct scan of pelvis.Recent lumbar anterior and posterior fusion can be seen l4 to s1.There is a collection of fluid in the left iliac fossa, anterior prevertebral space and infraumbilical region below the inferior aspect of the incision.Subtle air-fluid levels in the intraperitoneal collections.Apparent fluid collections in the anterior paraspinous region, left iliac fossa are contiguous and track to the level of the left psoas muscle, which is diffusely edematous.Communication with the subcutaneous collection however is not well appreciated.Probable postoperative hematoma, serorna.Infection of this collection is difficult entirely excluded.There are areas of loculation of the collection suggested, suggesting early organization.Recent anterior and posterior lumbar decompression and fusion l4 to s1, vas described.Anterior component l5-s1 is seen along with posterior bilateral pedicle screws l4 and s1 with connecting arch bars.Bone graft harvest right iliac crest is suggested.Central canal through the fused segments appears to be patent.There is advanced degenerative disc disease l4-l5 present.Disc space maintenance at l4-l5 and l5-s1 can be seen.On (b)(6) 2012 patient presented with acquired spondylolisthesis, abdominal pain, epigastric pain, palpitations, abnormal mammogram, disc disease, lumbar l4-5 r effacement, other specified disease of nail, elevated blood pressure, hypercholesterolemia, insomnia, dysmenorrhea, premenstrual dysphoric syndrome, chromopertubation, lymphedema.On (b)(6) 2012, (b)(6) 2012 patient presented with post op follow up visit.Patient underwent x-rays of lumbar spine.Impression: chronic l45 and l5-s1 degenerative disk changes with grade 1-2 lytic spondylolisthesis (l5-s1) a.1 month sip l4-5, l5-s1 360 fusion.History of inconsistent and inappropriate uds - off all narcotics pills at the present.Insomnia - wishes to try halcion which has helped in the past.On (b)(6) 2013 patient presented for consultation on hypothyroidism/abnormal weight gain.Assessment: hypothyroidism.Last tsh elevated but she was off medication - needs a repeat test today.Abnormal weight gain despite diet and exercise - this was present prior to her surgery - will check for endocrine causes.Fatigue.Multifactorial and in part her poor sleep.On (b)(6) 2013, (b)(6) 2013 patient presented for follow up of l 4-5, l5-s1 360 fusion.Patient underwent lumbar spine x ray.Impression: chronic l4s and ls-s 1 degenerative disk changes with grade 1-2 lytic spondylolisthesis (ls-s1).A.3 months sip l4-s, ls-s1 360 fusion.History of inconsistent and inappropriate uds - off all narcotics pills at the present.Insomnia - wishes to try halcion which has helped in the past.Recent onset l psis region pain/ si joint dysfunction symptoms/ trigger point and l leg ls dermatomal sciatica.On (b)(6) 2013 patient presented with back pain.Patient underwent radiographic lumbar spine x ray.Impression: chronic l45 and l5-s1 degenerative disk changes with grade 1-2 lytic spondylolisthesis (l5-s1).A.3 months sip l4-5, l5-s1 360 fusion.History of inconsistent and inappropriate uds - off all narcotics pills at the present.Insomnia - wishes to try halcion which has helped in the past.Recent onset l psis region pain/ si joint dysfunction symptoms/ trigger point and l leg l5 dermatomal sciatica.On (b)(6) 2013 patient presented for follow up of hypothyroidism/ abnormal weight gain.Assessment: hypothyroidism.She needs more thyroid hormone she is willing to increase dose.Weight loss with diet /very nice.Fatigue likely from thyroid -if persists with normal tsh will consider sleep study joint aches likely from thyroid - will test for autoimmune joint disease if persists once tsh normal.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5049286
• MDR Text Key: 24883199
• Report Number: 1030489-2015-02176
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510800
• Device Lot Number: M1111D3AAO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Weight: 86