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 Hematoma (1884); Incontinence (1928); Neuropathy (1983); Injury (2348); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2007, the patient underwent spine fusion surgery on the thoracic and lumbar region at levels t4-s1.During the surgery, the patient was implanted with rhbmp-2 and collagen sponge.The rhbmp-2 collagen sponge was applied from posterolateral approach.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine and was placed outside a cage (i.E.In the posterolateral gutters).Post-op, the patient complained of progressively worsening pain in her low back and radiculopathy into her lower extremities., due to which patient underwent revision surgery.On (b)(6) 2012, the patient underwent spine fusion surgery on the thoracic region at levels t1-t7.During the surgery, the patient was implanted with rhbmp-2 and collagen sponge.The rhbmp-2 collagen sponge was applied from posterolateral approach.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine and was placed outside a cage (i.E.In the posterolateral gutters).Post-op, the patient complained of progressively worsening pain in her lower back, with radiculopathy into her lower extremities.Patient still continues to experience severe and unrelenting pain in her low back with radiculopathy into her lower extremities.Patient has difficulty standing for any length of time and walking any distance, and requires the use of a cane to assist in ambulation.Patient injuries prevented her from practicing daily life activities and reportedly the patient has suffered serious and permanent injuries.

Manufacturer Narrative

(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.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on, (b)(6) 2012, patient underwent following procedure: removal of t1 to s1 and pelvis instrumentation (stainless steel).Exploration of fusion.Re-instrumentation t1 to t12 with titanium.T1 to t7 posterolateral fusion using autogenous bone, 1 large kit bmp, 10ml of bone graft; for pre-op diagnosis of: drainage from spine secondary to possible infection.Non-union.Scoliosis.Stenosis.Per-op notes: ".The screws were all removed in lumbar spine as well as the pelvis.Again, there was little pockets of pus associated with the pelvic wing screws.The fusion appeared solid.We replaced thoracic screws with 70 x 40 at t10, t11, t12 on the right and t11 and t12 on the left.The t9 screw did not appeared to be good so it was left out.The bone graft was performed after decortication.Patient was taken to recovery room in stable condition." on (b)(6) 2012, the patient underwent x rays of the thoracolumbar spine.Impressions: post revision of spinal fusion.Minimal midthoracic scoliosis convex to the left.On (b)(6) 2012, patient presented for follow-up after removal of stainless steel rods and placement of titanium rods.On (b)(6) 2012, patient presented for follow-up two weeks post-op removal of instrumentation from t1 to pelvis and re-instrumentation t1-t12.Scoliosis x-rays showed remaining thoracic instrumentation in good position from t1 to t12.On (b)(6) 2012, patient presented for post-op follow-up.On (b)(6) 2012, patient presented with complaints of dysuria and urge incontinence.Patient reported incontinence and severe pain.On (b)(6) 2012, the patient underwent x rays of the lumbosacral spine and thoracic spine.Impression: no fracture-dislocation lumbosacral spine.No change in alignment of lumbar sacral spine.Posterior bony fusion and resection of posterior spinous processes unchanged from (b)(6) 2012 scoliosis films.Status post posterior surgical fusion od thoracic spine with alignment unchanged.Metallic cylinder in place and upper thoracic spine unchanged.The patient also underwent mri of the thoracic spine.Impressions: multi level post-operative change again noted with extensive artifact significantly limits evaluation of the thoracic spine.Scattered degenerative change.No definite spinal cord deformity.Follow up ct myelogram could be performed for further evaluation if needed.The patient also underwent x rays of the lumbar spine.Impression: extensive post operative change status post anterior lumbar discectomy bony fusion extending l2-3 through l5-s1.Prior hardware removal partial posterior decompressions posterior lateral bony fusions.Persistent hardware fusion again noted lower thoracic spine.A large septated fluid collection in posterior para spinous soft tissue as above possible minor foci of air.Although this may be secondary to post operative change hematoma, seroma infection abscess is not excluded.Multilevel spinal stenosis most marked with moderate spinal stenosis l5-s1.Multilevel foraminal narrowing most marked right l4-5 bilaterally l5-s1 greater right.Scattered degenerative change elsewhere are lower thoracic lumbar spine.Slight loss of lordosis minor multilevel anterior retrolisthesis scoliosis.On (b)(6) 2012, the patient underwent ct scan of the lumbar and thoracic spine.Impression: ct guided aspiration of lumbar paraspinal fluid.Deep midline posterior fluid collection extending along the lumbar spine.Fluid was aspirated for cultures.No complications were noted.The patient underwent mri of the lower back.Impressions: once again, exam significantly limited secondary to extensive post operative fusion changes through out the thoracic spine resulting susceptibility artifact.Allowing for these limitations, there is no obvious new compression fracture or spondylolisthesis.No obvious new vertebral body or disc space edema evident that would clearly indicate osteomyelitis.No definite new large disc extrusion or spinal stenosis although evaluation must be considered limited for these purposes.No obvious new paraspinal soft tissue inflammatory collection or fluid collection identified, although once again, evaluation limited.Somewhat smaller but still extensive rim-enhancing deep midline posterior fluid collection, consistent with hematoma, seroma, or csf pseudocyst, potentially infected.This is certainly amenable to percutaneous aspiration.No findings indicative of osteomyelitis.Post operative changes from spinal fusion.Pre-existing fusion rods on the lower thoracic and upper lumbar levels.These extend to l1 inferiorly.On (b)(6) 2012, patient presented for follow-up.Patient reported pain.Mri of thoracic and lumbar spine showed a lot of fluid collection.On (b)(6) 2012, patient presented for follow-up and reported back pain, located over lower back and hip area.Patient reported that three weeks after surgery she developed urinary incontinence.On (b)(6) 2012, patient presented for follow-up on seroma on lower back.Patient reported moderate pain in left hip region which radiates down the leg.On (b)(6) 2012, patient presented for follow-up.Patient reported low back pain.Scoliosis x-ray showed instrumentation from t1 to t12.She had good balance and correction of deformity was maintained.On (b)(6) 2012, patient presented for follow-up.Urine culture was tested positive two weeks ago.On (b)(6) 2012, patient presented with complaints of dysuria and urge incontinence.Patient also reported nocturia.On (b)(6) 2012, (b)(6) 2013, patient presented for follow-up and evaluation on post-op back infection.On (b)(6) 2012, patient presented for six month follow-up for fusion and removal of instrumentation.Patient reported occasional back pain.Scoliosis x-ray showed instrumentation from t1 to t12.On (b)(6) 2013, patient presented for office visit with chief complaint of history of urinary tract infection.On (b)(6) 2013, (b)(6) 2014, (b)(6) 2015, patient presented for follow-up on treatment and evaluation of prosthetic spinal hardware infection.Patient reported mild pain.On (b)(6) 2013, patient presented for follow-up on recurrent urinary tract infection and history of overactive bladder.On (b)(6) 2013, patient presented for follow-up on treatment and evaluation of prosthetic spinal hardware infection.Patient reported a click in hip.X-ray was done which showed no abnormalities.On (b)(6) 2014, patient presented with recurrent urinary tract infection, urgency/frequency.On (b)(6) 2014, patient presented with complaints of overactive bladder.On (b)(6) 2014, patient presented for follow-up on right total hip replacement 11 years post-op.Patient underwent x-ray of right hip for follow-up on right total hip replacement.Impression: stable right total hip replacement.Patient underwent x-ray of pelvis for follow-up on right total hip replacement.Impression: stable right total hip replacement.Mild to moderate osteoarthritis left hip.On (b)(6) 2015, patient presented for office visit with complaints of overactive bladder.

• 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: 4893977
• MDR Text Key: 21766986
• Report Number: 1030489-2015-01379
• 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,consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2015
• Device Catalogue Number: 7510800
• Device Lot Number: M111108AAI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2015
• Initial Date FDA Received: 07/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/23/2012
• 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