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 Appropriate Term/Code Not Available (3191)

Patient Problems Neuropathy (1983); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Neither device nor applicable imaging studies returned to manufacturer for evaluation.

Event Description

It was reported that on (b)(6) 2010 the patient presented with bilateral leg swelling and back pain.The patient underwent ct myelogram, which revealed lucencies around the ti2 screws cephalad with impingement upon the ti2 superior end plate.No other neurologic impingement or screw malpositioning is present.Radiographs, standing ap and lateral views of the lumbar spine show 32 degrees of kyphosis at the t11 through 11junction on a spot lateral of the thoracolumbar junction.Ap and lateral of the lumbar spine otherwise shows good alignment of his lumbar lordosis.Assessment: adjacent level kyphosis after t12-s1 posterior fusion and l3 osteotomy, concern for dvt bilateral lower extremities.On (b)(6) 2010: the patient underwent tll-ti2posteriorosteotom, ti-li posterior spinal fusion for deformity utilizing local autogenous and bone graft and allograft rh-bmp2/acs, ti-li segmental instrumentation.Preoperative diagnoses: t11- ti2 adjacent level kyphosis, loss of fixation at t12.Indication for procedure: a (b)(6) male status post an l3 osteotomy with good correction of his spine alignment and resolution of his preoperative symptoms.He developed crepitation pain and adjacent level kyphosis with loss of fixation at t12.Risk and benefits of surgical intervention were discussed with the patient.He consented for the procedure.Per-op notes: the wound was irrigated multiple times at the end of the procedure with bulb syringe saline.The spinous processes and lamina were removed with a rongeur and morselized for autogenous bone grafting.Large 2 rh-bmp2/acs kits were then cut longitudinally and a "fajita" construct was made with the bone graft and the rh-bmp2/acs and laid along the exposed the decorticated lamina from t3-ll.Final images were obtained which showed adequate placement of all implants and realignment of the spine.Crosslinks were placed at the caudal and cephalad extent of the new construct.Two deep drains were placed on each side of the posterior spine.Three grams of powdered vancomycin was then scattered throughout the exposed wound.The wound was then closed in a layered fashion with absorbable suture in the fascia and subcutaneous tissue and staples in the skin.On (b)(6) 2010: the patient was discharged.Discharge diagnosis: adjacent level kyphosis with loss of fixation at t12.On (b)(6) 2010 the patient presented with two weeks status post extension of fusion and osteotomy for adjacent level kyphosis.Patient underwent x-ray.Impression: radiographs of his spine show implants in good position with good sagittal alignment.Restoration of his adjacent level angulation.Findings: two weeks status post t3-ll adjacent level posterior fusion with osteotomy.On (b)(6) 2010 the patient presented with three months status post l3 osteotomy and six weeks status post extension of fusion to t3.Patient underwent x-ray.Impressions: ap lateral thoracic spine and ap lateral lumbar spine show implants in good position.He has positive sagittal alignment due to the junctional kyphosis developed at t12.There is also lucencies around his s1 screws bilaterally.Posterior lateral fusion mass is present from l1 down to l5 and potentially the sacrum.Assessment: three months status post l3 osteotomy with subsequent extension up to t3.Right lumbar radiculitis, concern for l5-s1 pseudoarthrosis.On (b)(6) 2010: the patient presented with right buttock pain in leaning forward patient underwent x-rays impression: radiographs of the thoracic and lumbar spine ap lateral shows good restoration of his lumbar lordosis with thoracolumbar kyphosis and positive sagittal imbalance.No loss of fixation at any level.Assessment flat back syndrome, right lumbar radiculitis, four months status post l3 osteotomy, two months status post extension of fusion up to t3.On (b)(6) 2010 the patient presented with bilateral buttock pain and leaning forward the patient underwent x-rays of lumbar spine.Impressions radiographs of his lumbar spine show positive sagittal imbalance.He has instrumentation without loosening from t3 to l5.Pedicle screws si have seem to have migrated caudally to their initial placement.The patient underwent ct myelogram shows adequate position of all implants from t3-l5.He has bone graft posteriorly at l5-s1.However, there are cephalocaudad halos around his pedicle screws at s1.The screws are now impinging upon the caudal aspect of the s1 pedicle near the foramen at s1.Assessment: lumbosacral pseudoarthrosis with loss of fixation and radiculitis.07 may 2010 the patient presented with evaluate bump on back.The patient underwent x-ray.Assessment: l5-s1 nonunion with lumbosacral kyphosis.

• 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: 5024161
• MDR Text Key: 23813610
• Report Number: 1030489-2015-02039
• 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: Other
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2012
• Device Catalogue Number: 7510800
• Device Lot Number: M110809AAN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/25/2009
• 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): Required Intervention