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

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

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.X-ray review results: post-op x-rays for thoraco lumbar sacral stabilization shows a unilateral rod fracture at the lumbo sacral transition.By report occurred, 24 months post-op fusion status is unknown, degree of deformity correction is unknown, but there appears to be partial collapse of the vertebra at this level.An interbody graft is also present here.Although it is unknown whether the product caused or contributed to the reported event, we are filling this mdr for notification purpose.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on: (b)(6) 2017: the patient was presented with the following pre-op diagnosis: l4 hemivertebrae with spine deformity associated with low back pain and radiculopathy.He underwent the following procedures: t10 to ileum arthrodesis using bmp allograft and autograft.L4 pedicle resection.L3/5 cage replacement.Kyphotix correction and derotation.Continuous intraoperative neuromonitoring with sseps, meps and emg.Operative findings: resection of the right l4 pedicle and placement of interbody cage.Good sagittal and coronal correction based on intraoperative fluoro at the end of the procedure.As per operative notes,¿ we tried several temporary spacers and decided to place a 14 mm x 26 mm cage, which provided the best fit based on lateral x-ray.The peek cage was then opened and packed with autograft bone.The cage was then placed under intermittent fluoro to confirm good orientation and proper position.A similar 5.5 mm cobalt chrome rod was then placed on the left an set screw were placed.Final lateral and ap x-rays show good cage placement as well as good correction of the kyphotic and scoliotic deformity.Once we were satisfied with the cage placement and deformity correction, final tightening was performed.The incision was copiously irrigated before the arthrodesis was performed.Using the high-speed drill, we decorticated from t10 to the ileum and packed the posterolateral margins with bmp and mixture of allograft and autograft.A medium-medium drain was placed and secured to the skin".On (b)(6) 2017: patient presented for 6-week post-operative appointment after staged procedure for thoracolumbar scoliosis correction with l4 vertebrectomy.He had history of imperforate anus, colostomy with chronic back pain and leg pain and scoliosis.His rle radicular pain that he had immediately after surgery has dissipated.His primary area of pain is in his low back and buttock on the left side.On (b)(6) 2017: patient presented for 3 months post-operative appointment.He has noticed an increase in his lower back pain and some left leg symptoms since that decreased.On (b)(6) 2017: the patient was presented with the following pre-op diagnosis: lumbar scoliotic deformity s/p t10-ilium fusion, with hardware failure.He underwent the following procedures: exploration of prior thoracolumbar instrumented fusion on the right side.With removal and replacement of right sided fractured rod.Placement of new right sided satellite rod.Placement of second right iliac screw.Operative findings: right sided fractured rod removed and replaced with two new cobalt chromium rods.Second right sided iliac screw placed to reinforce construct.On (b)(6) 2017: patient presented for 6 weeks post-operative appointment after revision t10 to ilium fusion after fracture of right rod.He denies any significant lower extremity pain.In general, he feels as through he is making significant progress.On (b)(6) 2017: the patient underwent x-ray thoracolumbar spine ap lateral examination.Impression: no displacement of fixation hardware following instrumentation from t10 to posterior iliac.On (b)(6) 2018: the patient presented for a follow-up visit.Assessment: status post right fusion.Osteoarthritis of first metatarsophalangeal joint.On (b)(6) 2018: patient presented for 6 months post-operative appointment after revision t10 to ilium fusion after fracture of right rod.He feels as though he is somewhat improved compared to pre-op but is frustrated that the left buttock and thigh symptoms persist.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on (b)(6) 2019, patient presented with back pain.Patient underwent x-ray scoliosis anterior posterior(ap) and lateral.Impression: patient status post t11-iliac posterior instrumented fusion without acute adverse features.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on: (b)(6)2017: patient underwent x-ray scoliosis ap and lateral.Impression: right thoracic, left thoracic, right lumbar, left lumbar scoliosis with dysplastic changes involving the lower sacrum.Cross section imaging of the sacroiliac joints and the sacrum may be useful for further assessment the nature of dysplastic changes and possible lower sacral spina bifida.Moderate diastases at the symphysis pubis.Suspect advanced chronic degenerative changes at the left sacroiliac joint.(b)(6) 2017: patient underwent x-ray chest portable.Impression: bibasilar atelectasis.(b)(6) 2017: patient underwent x-ray scoliosis ap and lateral.Impression: interval partial posterior spine instrumentation from t10 to bilateral ilia following lumbosacral region hemivertebra resection.Residual scoliosis curves.Patient underwent x-ray scoliosis ap and lateral.Impression: t11 through ilium posterior screw and rod fixation with interval bilateral fixation rod revision since (b)(6) 2017 without evidence of complication.Decreased magnitude of thoracolumbar and lumbar scoliosis.Dilated small bowel in the right abdomen and pubic diastases.Unchanged persisting right thoracic, left thoracic scoliosis above the level of posterior spinal instrumentation.(b)(6) 2017: patient presented with bladder/back pain.(b)(6) 2017: patient underwent x-ray thoracolumbar spine ap and lateral.Impression: unchanged alignment following posterior fixation from t10 to posterior ilia.(b)(6) 2017: patient presented for office visit with low back pain.Diagnosis: low back pain, scoliosis unspecified.Patient underwent x-ray of lumbar spine.Impression: fractured harrington rod on right at s1 level.No acute abnormality.Patient underwent x-ray of thoracic spine.Impression: scoliosis with previous thoracolumbar fusion posteriorly.No acute abnormality.(b)(6) 2017: patient underwent computed tomography of thoracic spine without contrast material.Impression: patient is status post posterior fixation from t10 to lumbar levels.Patient underwent computed tomography of thoracic spine without contrast material.Impression: status post posterior fixation from t11 to bilateral iliac bones with l4 vertebrectomy and multilevel bone chip placement.The screw appears in place with no evidence of surrounding areas of translucency.Redemonstration of s-shaped scoliosis.(b)(6) 2017:patient underwent x-ray scoliosis ap and lateral.Impression: posterior spinal fusion from t11 to posterior ilium with interval placement of the right sided rod.Moderate dextroscoliosis of the upper thoracic spine.(b)(6) 2017: patient underwent x-ray thoracolumbar spine ap and lateral.Impression: unchanged alignment following posterior instrument.(b)(6) 2018: patient underwent x-ray scoliosis ap and lateral.Impression: patient status post posterior instrumented fusion from t11 to iliac without acute adverse features.Dextroscoliosis of upper thoracic spine, similar in appearance.

• 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 USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8393522
• MDR Text Key: 137935561
• Report Number: 1030489-2019-00225
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2019
• 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 Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 76