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 Arthritis (1723); Neuropathy (1983); Pain (1994); Weakness (2145); Burning Sensation (2146); Stenosis (2263)

Event Type  Injury  

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.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) 2008: the patient presented with previous lumbar fusion at l5-s1.Spondylolisthesis at l5-s1.Non-union at l5-s1.Painful deep hardware.Radiculopathy and weakness, left lower extremity worse than the right.The patient underwent the following procedures: revision lumbar hemilaminectomies with medial fasciectomies and foraminotomies for decompression of dura and neural elements.Excision of non-union with partial excision of inter-body cage device at l5-s1.Revision inter-body fusion and inter-body cage device insertion using interbody cage device at l5-s1.Revision posterolateral fusion at l5-s1 for completion of anterior and posterior column fusion through the single posterior incision.Revision instrumentation using pedicle screw instrumentation system at l5-s1.Removal of hardware at l5-s1.No patient complications were reported.On (b)(6) 2009: the patient underwent whole body bone scan due to history of l5-s1 fusion and sacro-iliac joint strain.Impression: degenerative appearing uptake at the l5-s1 level.Bilaterally increased uptake in the sacro-iliac joints also thought to be degenerative in nature.On (b)(6) 2009: the patient presented with spondylolisthesis at l5-s1.Previous lumbar fusion at l5-s1.Revision fusion at l5-s1.History of breast carcinoma with metastatic breast disease.Right lower extremity radiculopathy and intermittent weakness.The patient underwent the following procedures: removal of the painful hardware at l5-s1.Inspection of fusion at l5-s1.No patient complications were reported.On (b)(6) 2010: the patient underwent mri scan of lumbar spine due to low back and left leg pain.Impression: post-operative changes at l5-s1.Residual or recurrent disc material is seen at l5-s1 centrally and to the left of midline with deformity of the thecal sac.Fibrotic changes within the left lateral recess may compromise either the existing left l5 and/0r descending left s1 roots.Some inferior foraminal disc material is identified on the right at l5-s1 as well.Grade i spondylolisthesis is seen at l5-s1 and healed spondylolysis is suspected bilaterally at this level.On (b)(6) 2013: the patient underwent ct scan of lumbar spine due to pseudo-arthritis, leg pain and right leg burning sensation.Impression: post-operative changes are seen at l5-s1 consistent with plif with subsequent removal of trans-pedicular hardware.Despite retropulsion of the interbody graft at l5-s1, interbody fusion at this level appears grossly intact.Post-operative fibrotic changes or granulation tissue are seen within the left spinal canal extending to the left lower recess.This fails to produce obvious deformity of the thecal sac but may compromise the descending left s1 root.Non-specific inferior foraminal disc material is seen on the left at the l4-5.The patient underwent mri scan, lumbar spine due to pseudo-arthritis, leg pain and right leg burning sensation.Impression: post-operative changes at l5-s1.Grade i spondylolisthesis is seen at this level uncovering the native l5-s1 disc and/or the inter-body graft posteriorly.Enhancing post-operative fibrotic changes or granulation tissue are seen within the laminectomy defect at l5-s1 extending to the left lateral recess where compromise of the exiting left l5 and/or descending left s1 roots may be present.On (b)(6) 2016: the patient underwent ct of lumbar spine without contrast due to indication of chronic low back pain.The results were compared with those obtained in the mri of lumbar spine dated (b)(6) 2016.Impression: chronic l5 pars defects with remote post-surgical changes at l5-s1.There is partial osseous fusion across the l5-s1 disc space.Hyper-dense material posterior to the disc space and the ventral epidural space measuring 3.5 mm ap * 14 mm cc appears extruded disc spacer material.There is a persistent 4 mm anterolisthesis at this level.Moderate bilateral foraminal stenosis at l5-s1 with compression of both l5 nerves.The patient underwent mri of lumbar spine without contrast due to indications of chronic low back pain, bilateral leg pain for 10 years and lumbar surgeries.Impression: grade 2 isthmic spondylolisthesis at l5-s1 with post-surgical changes.No recurrent disc herniation but with epidural scar tissue.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on (b)(6) 2008 it was reported that the patient was admitted to the facility where the patient underwent spine fusion surgery using rhbmp2 on the lumbar region of spine from vertebrae l5-s1.The rhbmp-2 collagen sponge was placed outside the cage.Post-op, patient reportedly had "severe pain radiating into her lower extremities".

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6033027
• MDR Text Key: 57559926
• Report Number: 1030489-2016-02922
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/09/2017

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: 12/01/2009
• Device Catalogue Number: 7510400
• Device Lot Number: M110609AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/20/2016
• Initial Date FDA Received: 10/17/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 01/09/2017
• Supplement Dates FDA Received: 10/18/2016; 02/02/2017; 09/25/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/20/2007
• 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