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

Catalog Number 7510400

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

Patient Problems Wound Dehiscence (1154); Contusion (1787); Neuropathy (1983); Sprain (2083)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2010, the patient underwent left extreme lateral interbody fusion with interbody cage, and beta tricalcium phosphate graft with rh-bmp2/acs at tl2-ll, l1-12, 12-l3, and l3-l4.Indication for procedure: a (b)(6) male, status post 13 osteotomy with extension of his fusion who developed a pseudarthrosis with broken rods at 13.He maintained positive sagittal imbalance, and risks and benefits of su rgical intervention versus continued nonoperative intervention were discussed with the patient.He signed a consent form after recommendation for the above procedure with a staged ll osteotomy per-op notes: the patient was seen in the holding room.He was turned in the right lateral decubitus position.After time-out was performed, a posterolateral incision was made and blunt dissection carried down to the fascia which was pierced with blunt scissors.Next, bilateral annulotomy was performed and a subtotal diskectomy down to subchondral bleeding bone was performed.Serial trials up to a size 10 lordotic cage was performed.There was opening of the disk space during trials.The cage was then selected and filled with beta tricalcium phosphate with rh-bmp2/acs sandwiched between.The cage was then malleted under fluoroscopy and final images showed restoration of disk height and lordosis and adequate placement of the implants.Bilateral annulotomy was performed and subtotal diskectomy down to subchondral bleeding bone was performed.The cage was inserted and disk height restoration was again noted.Less lordotic restoration was achieved.A 10 mrn lordotic cage was selected and filled with beta tricalcium phosphate and rh-bmp2/acs graft.Next, under fluoroscopic guidance another direct lateral incision was made overlying the ll-2 disk space.This was in the intercostal space of til and 12.Serial dilation tubes were placed and a self-retaining retractor placed.The psoas muscle utilizing neuro monitoring, with no stimulation.Bilateral annulotomy performed and subtotal diskectomy down to subchondral bleeding bone.Serial trials up to a size 12 flat was performed.The cage was then selected, filled with beta tricalcium phosphate graft and rh-bmp2/acs and malleted into place under fluoroscopic guidance into adequate position.A bilateral annulotomy was performed with subtotal discectomy down to subchondral bleeding bone.Serial trials up to a size 10 flat was performed.The cage was then selected to bold rh-bmp2/acs and beta tricalcium phosphate and malleted into place under fluoroscopic guidance.Valsalva maneuver was performed and no parenchymal lung leak was identified.Preoperative diagnosis: l2-3 and l3-4 pseudarthrosis, anticipated ll osteotomy with fusion takedown from tl2-l2.On (b)(6) 2010: the patient underwent surgery.Wherein implanted with pedicle screws and rods.Preoperative diagnoses: l2-4 pseudarthrosis, flat back syndrome.Procedure performed: ll osteotomy cpt , posterior spinal fusion, t12-la for deformity utilizing local autogenous bone graft, reinsertion of spinal iliac fixation.On (b)(6) 2010: the patient was discharged.Discharge: lumbar pseudarthrosis, recurrent flat-back syndrome.Procedure performed: t12 through l4 extreme lateral interbody fusion, l1 osteotomy with posterior spinal fusion, t12 through l4.On (b)(6) 2010: the patient presented with chief complaint five weeks status post anterior/posterior ll osteotomy with fusion.Radiographs revealed ll osteotomy has collapsed but the cages are in good position from t12 to l4.Assessment: five weeks status post anterior/posterior spinal fusion with ll osteotomy.On (b)(6) 2010, the patient presented with ten weeks status post ll osteotomy with revision ti2-l4 fusion.The patient underwent x-rays, which revealed that patient has complete collapse with loss of lordosis ll osteotomy level.He has 12 cm of sagittal imbalance.Assessment: ten weeks status post ti2-l4 anterior posterior fusion with osteotomy at l1.On (b)(6) 2010: the patient presented with two weeks status post ll osteotomy and ti2-l4 xlif.Patient underwent x-ray impression: ap lateral scoliosis films show positive sagittal imbalance, improved from preop.No coronal imbalance.His rods are all intact.Cages are all in disk spaces.Standing ap lateral lumbar spine shows vertebral body collapse at ll , comparison with his immediate postoperative films show loss of lordosis at that level.Assessment: two weeks status post ti2-l4 xlif and ll osteotomy.On (b)(6) 2011, the patient presented for follow-up lumbar osteotomy.Assessment: seven months status post ll osteotomy and fusion for pseudoarthrosis.On (b)(6) 2011, the patient presented with chief complaint of back pain assessment: right wrist sprain, lumbar contusion, chronic pain.On (b)(6) 2011, the patient presented with chief complaint of back wound.Assessment: lumbar decubitus ulcer.On (b)(6) 2012, the patient was admitted for wound dehiscence and radiculopathy.Patient suffered from stabbing back pain.The patient a lso had infection.He also experienced erythema and swelling in his legs.

• 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: 5024185
• MDR Text Key: 23804574
• Report Number: 1030489-2015-02045
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2013
• Device Catalogue Number: 7510400
• Device Lot Number: M110905AAD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/21/2010
• 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